Common Submission Dossier Template

COMMON SUBMISSION DOSSIER TEMPLATE
MEDICAL DEVICE NAME : Oxygen Concentrator

DEVICE OWNER NAME : AngelBiss Medical Technology Co.,Ltd
Prepared by ( Name / Signature ) : Avan Li

Approved by ( Name / Signature ) : Alla Huang
Date : 2020-Oct-08
1
Synopsis of the content Page
1. Executive Summary ……………………………………………………………………….3

2. Relevant essential principles and rule used to demonstrate conformity ..........8
3. Description and Features ………………………………………………………………………..37
4. Intended use …………………………………………………………………………………………….. 37
5. Indications of use ……………………………………………………………………………………………. 38
6. Instructions of use on the device ……………………………………………..……………. 38
7. Other relevant Specifications……………………………………….……….………………………….38
8. Contraindications …………………………………………….…………………..……….…….. 38
9. Warnings……………………………………………………………………..…………………………………..38
10. Precautions………………………………………………………………….……………..…………………..39
11. Potential adverse effects………………………………………………………………………………..39
12. Alternative therapy………………………………………………………………….……………………..39
13. Materials………………………………………………………………………………………………………..39
14. Other Relevant Specifications………………………………………………………………………..39
15. Other Descriptive Information………………………………………………………………………..40
16 Summary of design verification and validation documents ……………………..……41
17 Medical device labelling……………………………………………………………………….………....47
18 Risk analysis …………………………………………………………………………………………....48
19 Manufacturer information ………………………………………………………………….……52
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1. Executive Summary
a. Overview
Introduction
The oxygen concentrator is composed of an oxygen concentrator main machine (including an air compressor, a molecular sieve tower, filters
and a master board), a flow meter and a humidifier
Oxygen Concentrator can produce high concentration oxygen. By the respiratory inhalation of oxygen, the oxygen will go through the human
body's blood via the circulation of the blood, thereby improving oxygen concentration of the body's blood, so as to prevent or delay the
process of copd, heart disease, and death from cancer.
Intended purposes
This product is suitable for oxygen-deficient patients and places where lack of centralized oxygen supply of medical units for oxygen
therapy or oxygen health care.
Use under the doctor's advice on oxygen inhalation time, oxygen flow, nebulize and need for humidification.
Indications for use
This product is used in hypoxia crowd, ease of fatigue, fatigue driving, high altitude hypoxia and other physical discomfort caused by hypoxia.
This product with simple operation, first to add right amount of pure water or distilled water into the humidifying bottle, connected with the
cannula, or the oxygen tubing and oxygen headset, then connected to the power supply, pressing the power switch to start with. The power
interface of the product has a preventive function design, with the same specifications on both ends of the pipe interface, to avoid incorrect
connection.
This product can be used under the condition of no great dust at room temperature, can not be used for life support.
This product provides oxygen by oxygen tube, humidifying bottle and cannula or oxygen headset for oxygen breathing.
The time of breathing is about 30 minutes each time. The frequency of touch was determined by the conditions of hypoxia.
Novel features
Along with the coming high peak of the aged generation as well the fast grow of the human life level, human start to focus more attention on
healthcare and decease treatments. The demands for medical devices are even larger than any area of other medical industries. In recent years
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there are many kinds of medical system reform and improvement happening in the countries worldwide. The hospitals quantity and the scale
are having obvious growth that will lead to a higher demand market for hospital management system, medical devices configuration and
medical devices quality. This feature determines the important role of the medical devices among the medical area.
Recent years, along with the high-tech science like medical electronics, engineering technology development, the oxygen equipments are
newly created or improved continuously. The performance requirements of the products in stability, durability, safety, multi-functionality,
portability and miniaturization are urgently issued. Product designs are also tended to be modular in structure and assemble workmanship. In
functional requirements, the direction for progress for complete functions, reasonable design, easy operation are naturally been demanded.
Low cost device, easy maintenance, to save treatment time on patients, improve work condition for doctors, reduce pain of patients and
decrease the labour strength are urgently requested.
Thus the oxygen concentrator as medical device takes one of the role to serve for human healthcare.
b. Commercial marketing history:
The current marketing strengths has been over 35 countries, below are some lists of them:
Year Product Name countries
2018 Oxygen Concentrator Ukraine
2018 Oxygen Concentrator Hotland
2018 Oxygen Concentrator Malaysia
2018 Oxygen Concentrator India
2018 Oxygen Concentrator South Africa
2018 Oxygen Concentrator Pakistan
2019 Oxygen Concentrator Indonesia

2019 Oxygen Concentrator Nepal
2019 Oxygen Concentrator Iraq
2019 Oxygen Concentrator Bangladesh
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2019 Oxygen Concentrator Iran
2019 Oxygen Concentrator Bulgaria

2020 Oxygen Concentrator Italy
2020 Oxygen Concentrator Yemen
2020 Oxygen Concentrator Philippines
2020 Oxygen Concentrator Vietnam
2020 Oxygen Concentrator Chile
c. Intended purposes
This product is suitable for oxygen-deficient patients and places where lack of centralized oxygen supply of medical units for oxygen
therapy or oxygen health care.
Use under the doctor's advice on oxygen inhalation time, oxygen flow, nebulize and need for humidification.
Indications in labeling
Symbol Meanings Symbol Meanings
～ Alternating current Warning
BF type application
Class II Equipment
equipment
Turn off (Main Power) Turn on (Main Power)
Date of manufacture Serial number
Manufacturer EC-representative
5
Refer to
Enforcement
instruction manual
operating
Prohibit
instructions
No open flame fire open

ignition source and smoking No smoking
prohibited
UP Fragile
Keep Dry Stack Limit
No Rolling Temp Limit
Humidity Limit Atmosphere Pressure Limit
d. List of regulatory approval
No. Standard Version Name of document
Medical devices - Symbols to be used with medical device

1 EN ISO15223-1 2016 labels, labelling and information to be supplied -- Part 1: General
requirements
2 EN 1041 2008 Information supplied by the manufacturer of medical devices
3 EN ISO 14971 2012 Medical devices - Application of risk management to medical

devices.
2005+ Medical electrical equipment — Part 1: General requirements for

4 IEC 60601-1
basic safety and essential performance
A1:2012
6
Medical electrical equipment - Part 1-2: General requirements
5 IEC 60601-1-2 2014 for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
6 EN ISO 10993-1 2009 Biological evaluation of medical devices -- Part 1: Evaluation and
testing
7 EN ISO 10993-5 2009 Biological evaluation of medical devices— Part 5: Tests for in
vitro cytotoxicity.
8 ISO 10993-10 2010 Biological evaluation of medical devices—Part 10: Tests for
irritation and delayed-type hypersensitivity.
9 EN 62366-1 2015 Medical devices - Application of usability engineering to medical

devices
10 EN 62304 2006 Medical device software — Software life-cycle processes
2010+ Medical electrical equipment –Part 1-6: General requirements

11 EN 60601-1-6 for basic safety and essential performance – Collateral
A1:2015 standard: Usability
Medical electrical equipment Part 2-69: Particular requirements

12 ENISO80601-2-69 2014 for basic safety and essential performance of oxygen
concentrator equipment
Medical electrical equipment - Part 1-8: General requirements

13 for basic safety and essential performance - Collateral Standard:
EN60601-1-8 2014 General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
e. Status of pending request for market clearance
There is no any pending request for market clearance.
f. Important Safety related information
No adverse event has been received for ANGEL-Series Oxygen Concentrator. For the other companies which have the similar products, we
check the website http://www.gdda.gov.cn/ and http://www.sda.gov.cn. There hasn’t any adverse event occur before. Thus there are not
significant adverse events over the years, and thus no need to do field corrective actions.
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2. Relevant essential principles and rule used to demonstrate conformity
Checklist according to annex I of the Medical Device Directive A/ Standards, other directives Documentation (test reports,
(MDD) NA and other rules applied by protocols, literature or reason
Position
适用/ manufacturer 制造商引用的 for no applicability) 支持性文
按医疗器械指令（MDD）附录一的基本位置
不适用标准，其它指件(测试报告，方案，
要求检查表
令或规则文献或不适用的理由)
I. General Requirements
通用要求
The devices must be designed and manufactured in such ENISO13485:2016 ENISO13485:2016 certificate
1.
a way that, when used under the conditions and for the
purposes intended, they will not compromise the clinical EN ISO14971:2012 Risk management report
(AB/CE01-06)
condition or the safety of patients, or the safety and
health of users or, where applicable, other persons,
provided that any risks which may be associated with Product test report No.:
IEC 60601-1: 2005+A1:2012 (7019818140301-11-0)
their intended use constitute acceptable risks when
IEC 60601-1-2: 2014 (7019818140301-12-0)
weighed against the benefits to the patient and are (SET2019-06911)
ENISO80601-2-69:2014
compatible with a high level of protection of health and (SET2019-06912)
EN 60601-1-8:2014
safety. 器械的生产和设计必须保证：按照其预定用途和条
件使用，器械不会损害临床条件、或患者安全、或操作者
Clinical evaluation report Technology
或其他人员的安全和健康；假设与器械预期用途相关的任 MEDDEV2.7.1 rev04 （ABS-JSB-06-003）
Dept .records
何风险，与之给患者带来的益处相比，并与健康安全的保
EN62366-1:2015 cabinet
护程度相一致，则是可接受的。 Usability report
EN 60601-1-6: 2010 （AB/CE01-12）
This shall include: +A1:2015
A
Software Validation report
Reducing, as far as possible, the risk of use error due to EN 62304:2006 （AB/CE01-13）
the ergonomic features of the device and the environment
in which the device is intended to be used (design for Instruction for use
patient safety), and ENISO15223-1:2016 （ABS-DT-UM-01）
EN1041:2008 Label
（AB/CE01-08/03）
Consideration of the technical knowledge, experience,
education and training and where applicable the medical Bio-compatibility
EN ISO 10993-5:2009
and physical conditions of intended users (design for lay, Certificate(suppli
ISO10993-10:2010
professional, disabled or other users). ers)
应包括： MD Essential
MD Directive Requirements
尽可能地降低由于器械的人体工学特征和器械预期使 2006/42/EC Checklist
用的环境（为患者安全设计的）的错误使用而产生的风（AB/CE01-
AX.8）
8
NA and other rules applied by protocols, literature or reason Position
(MDD)
适用/ manufacturer 制造商引用的 for no applicability) 支持性文位置
按医疗器械指令（MDD）附录一的基本
要求检查表
险，和考虑技术知识、经验、教育和培训，预期用户（为
非专业人员、专业人员、伤残人员或其他人）的医疗和身
体条件。
The solutions adopted by the manufacturer for the design ENISO13485:2016 ENISO13485:2016 certificate
2.
and construction of the devices must conform to safety
principles, taking account of the generally acknowledged EN ISO14971:2012 Risk management report
(AB/CE01-06)
state of the art.
In selecting the most appropriate solutions, the Product test report No.:
manufacturer must apply the following principles in the IEC 60601-1: 2005+A1:2012 (7019818140301-11-0)
following order: (7019818140301-12-0)
IEC 60601-1-2: 2014 (SET2019-06911)
ENISO80601-2-69:2014 (SET2019-06912)
·Eliminate or reduce risks as far as possible (inherently EN 60601-1-8:2014
safe design and construction),
Clinical evaluation report
（ABS-JSB-06-003）
· where appropriate take adequate protection measures MEDDEV2.7.1 rev04 Technology
including alarms if necessary, in relation to risks that Usability report Dept .records
cannot be eliminated, （AB/CE01-12） cabinet
EN62366-1:2015
A EN 60601-1-6: 2010
▪ Inform users of the residual risks due to any +A1:2015 Software Validation report
（AB/CE01-13）
shortcomings of the protection measures adopted.
EN 62304:2006
Instruction for use
制造商采用的器械结构和设计方案，必须考虑在当前（ABS-DT-UM-01）
工艺技术条件下遵守安全原则。 ENISO15223-1:2016
EN1041:2008 Label
（AB/CE01-08/03）
在选择最合适方案时，制造商应按照以下顺序遵守原则：
可能地降低或避免风险
Bio-compatibility
（固有的安全设计和结构）对无法避免的风险，如适 EN ISO 10993-5:2009
Certificate(suppli
用，采取适当的防护措施，包括必要的报警。 ISO10993-10:2010
ers)
告知用户由于所提供防护措施的缺陷而带来的残留风 MD Essential Requirements

险。 MD Directive Checklist（AB/CE01-AX.8）
2006/42/EC
9
(MDD)
要求检查表
3. The devices must achieve the performances intended by
EN62366-1:2015 Usability report
the manufacturer and be designed, manufactured and （AB/CE01-12）
EN 60601-1-6: 2010
packaged in such a way that they are suitable for one or +A1:2015 Instruction for use Technology
more of the functions referred to in Article 1 (2) (a), as EN1041:2008 （ABS-DT-UM-01）
A Dept .records
specified by the manufacturer. cabinet
IEC 60601-1: Product test report No.
器械最后必须取得制造商期望获得的功能。器械设 (7019818140301-11-0)
计、制造和包装应与第1 条(2)(a)制造商所规定的一项或多 2005+A1:2012 (7019818140301-12-0)
项功能相适应。 IEC 60601-1-2: 2014 (SET2019-06911)
ENISO80601-2-69:2014 (SET2019-06912)
EN 60601-1-8:2014
Software Validation report
EN62304:2006 （AB/CE01-13）
MD Requirements
MD Directive 2006/42/EC Checklist（AB/CE01-AX.8）
ENISO14971:2012 Risk management report

4. The characteristics and performances referred to in (AB/CE01-06)
sections 1, 2 and 3 must not be adversely affected to EN1041:2008
such a degree that the clinical condition and safety of the Instruction for use
（ABS-DT-UM-01）
patients and, where applicable, of other persons are IEC 60601-1:
compromised during the lifetime of the device as 2005+A1:2012 Product test report No. Technology
indicated by the manufacturer, when the device is A Dept .records
IEC 60601-1-2: 2014 (7019818140301-11-0)
subjected to the stresses which can occur during normal (7019818140301-12-0) cabinet
ENISO80601-2-69:2014
conditions of use. EN 60601-1-8:2014 (SET2019-06911)
(SET2019-06912)
在制造商确定的器械使用寿命期内，在正常使用可能出
MEDDEV2.7.1 rev04
现的压力下，第1，2，3 款指的各项特征和性能应不能影 Clinical evaluation report
响临床条件、危害患者或其它人员的安全。（ABS-JSB-06-003）
EN ISO15223-1:2016 Label
5. The devices must be designed, manufactured and （AB/CE01-08/03）
packed in such a way that their characteristics and EN 1041:2008
performances during their intended use will not be Instruction for use
（ABS-DT-UM-01） Technology
adversely affected during transport and storage taking EN62366- Dept .records
account of the instructions and information provided by A 1:2015 cabinet
the manufacturer. EN 60601-1-6: 2010 Usability report
（AB/CE01-12）
器械设计、生产和包装应当保证器械的特征和性能在 +A1:2015
运输和储存过程中，只要遵守制造商提供的有关说明和信
息，就不会受到重大影响。
10
Risk management report
6. Any undesirable side effects must constitute an EN ISO14971:2012 (AB/CE01-06)
acceptable risk when weighed against the performances A MEDDEV2.7.1
rev04 Technology
intended. Clinical evaluation report Dept .records
EN62366-1:2015 （ABS-JSB-06-003） cabinet
EN 60601-1-6: 2010
Usability report
+A1:2015
（AB/CE01-12）
(MDD)
要求检查表
副作用的大小同器械的预期性能相比，是可接受的风
险。
6a. Demonstration of conformity with the essential EN ISO14971:2012 Risk management report
requirements must include a clinical evaluation in (AB/CE01-06) Technology
A MEDDEV2.7.1 rev04
accordance with Annex X. Dept .records
证明符合基本要求必须包括按照附录X 的临床评估 Clinical evaluation report cabinet
（ABS-JSB-06-003）
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

设计和结构的要求
7. Chemical, physical and biological properties

化学、物理和生物特征
11
7.1 The devices must be designed and manufactured in such
a way as to guarantee the characteristics and
performances referred to in Section 1 on the "General
requirements". Particular attention must be paid to:
the choice of materials used, particularly as
regards toxicity and, where appropriate flammability,
the compatibility between the materials used and
Technology
biological tissues, cells and body fluids, taking account
Risk management Dept .records
of the intended purpose of the device. EN ISO14971:2012 cabinet
report (AB/CE01-06)
Where appropriate, the results of biophysical or A
ENISO13485:2016 Package records Production
modelling research whose validity has been (ABS-QR-10-05) Dept .records
demonstrated beforehand. Clause 7.5.11
cabinet
器械的设计和生产必须保证达到本附录第I 部分的通 Bio-compatibility
EN ISO 10993-5:2009, Certificate(suppliers)
用要求，另外应特别注意： Technology
ISO10993-10:2010 Dept .records
合理选择原料，特别是易燃物质和有毒物质的选
择； cabinet
从器械预定功能出发考虑所选材料同人体生物组
织、细胞和体液的相容性。
如适用，事先已确认有效的生物物理学或模型研
(MDD)
要求检查表
究的结果
EN ISO14971:2012 Risk management

7.2 The devices must be designed, manufactured and Technology
packed in such a way as to minimise the risk posed by report (AB/CE01-06) Dept .records
ENISO13485:2016 cabinet
contaminants and residues to the persons involved in the Clause7.5.11, Package records
transport, storage and use of the devices and to the 8.2.6 (ABS-QR-10-05) Production
patients, taking account of the intended purpose of the Final inspection report Dept .records
A (ABS-QR-16-03) cabinet
product. Particular attention must be paid to the tissues ENISO80601-2-
exposed and the duration and frequency of the exposure. 69:2014
Test report No. Quality
器械的设计、制造和包装应当保证器械在运输、储存 (SET2019-06911) Dept .records
和使用过程中的污染和残留物对人体危害最低，应特别注 EN ISO 10993-5:2009 Bio-compatibility cabinet
意观察暴露于器械下的人体组织及其时间和频率。 ISO10993-10:2010 Certificate(suppliers)
12
7.3 The devices must be designed and manufactured in such
a way that they can be used safely with the materials,
substances and gases with which they enter into contact
during their normal use or during routine procedures; if
the devices are intended to administer medicinal products
they must be designed and manufactured in such a way Risk management
as to be compatible with the medicinal products Technology
EN ISO14971:2012 report (AB/CE01-06) Dept .records
concerned according to the provisions and restrictions A cabinet
governing those products and that their performance is ENISO80601-2-69:2014 Test report No.
maintained in accordance with the intended use. (SET2019-06911)
器械设计和生产必须保证在正常使用和常规过程中接
触其它材料、物质和气体不会影响其安全使用；如果器械
需要加载其它药品，器械的设计和生产必须保证同该药品
相兼容，必须考虑法规对该药品的规定和限制，保证器械
达到预定功能。
/ The device does not include /

7.4 Where a device incorporates, as an integral part, a N.A
substance which, if used separately, may be considered medicinal materials
to be a medicinal product as defined in Article 1 of
Directive 2001/83/EC and which is liable to act upon the
(MDD)
要求检查表
13
body with action ancillary to that of the device, the quality, N.A / The device does not include /
safety and usefulness of the substance must be verified medicinal materials
by analogy with the methods specified in Annex I to
Directive 2001/83/EC.
如果某种器械含有某种物质作为其组成部分，而且该
物质单独使用时可被认为是2001/83EC 第1 条含义内的药
品，并且它能够帮助该器械对人体产生辅助作用，这种物
质的安全性、质量和有效性必须通过2001/83/EC 指令附
录I 涉及的适用方法进行类推来确认。
For the substances referred to in the first paragraph, the

notified body shall, having verified the usefulness of the
substance as part of the medical device and taking
account of the intended purpose of the device, seek a
scientific opinion from one of the competent authorities
designated by the Member States or the European
Medicines Agency (EMEA) acting particularly through its
committee in accordance with Regulation (EC) No
726/20041 on the quality and safety of the substance
including the clinical benefit/risk profile of the
incorporation of the substance into the device. When
issuing its opinion, the competent authority or the EMEA
shall take into account the manufacturing process and the
data related to the usefulness of incorporation of the
substance into the device as determined by the notified
body.
对于第一段提到的物质，在考虑到该器械的预期用途
时确认了该物质作为医疗器械一部分的有效性之后，公告
机构应按 Regulation (EC) No 726/20041 法规，就该物质
的质量和安全性包括该物质与器械整合的临床受益/风险特
性，向成员国指定的一个主管当局或欧洲药品评价署
1
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures
for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines
Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regulation (EC) No 1901/2006.
14
(MDD)
要求检查表
（EMEA）特别是其委员会寻求科学意见。当发表其意见 / The device does not include
N.A /
时，主管当局或EMEA 应考虑公告机构认定的关于该物质 medicinal materials
与器械整合有效性的生产过程和数据。
Where a device incorporates, as an integral part, a
human blood derivative, the notified body shall, having
verified the usefulness of the substance as part of the
medical device and taking into account the intended
purpose of the device, seek a scientific opinion from the
EMEA, acting particularly through its committee, on the
quality and safety of the substance including the clinical
benefit/risk profile of the incorporation of the human blood
derivative into the device. When issuing this opinion, the
EMEA shall take into account the manufacturing process
and the data related to the usefulness of incorporation of
the substance into the device as determined by the
notified body.
如果某种器械含有人血制品作为其组成部分，在确认
了该血制品作为医疗器械一部分的有效性，并考虑到该器
械的预期用途的基础上，公告机构应就该制品的质量和安
全性包括该制品与器械整合的临床受益/风险特性，向欧洲
药品评价署（EMEA）特别是其委员会寻求科学意见。当
发表其意见时，主管当局或 EMEA 应考虑公告机构认定
的关于该物质与器械整合有效性的生产过程和数据。
Where changes are made to an ancillary substance
incorporated in a device, in particular related to its
manufacturing process, the notified body shall be
informed of the changes and shall consult the relevant
medicines competent authority (i.e. the one involved in
the initial consultation), in order to confirm that the quality
and safety of the ancillary substance are maintained. The
competent authority shall take into account the data
related to the usefulness of incorporation of the
substance into the device as determined by the notified
body, in order to ensure that the changes have no
negative impact on the established benefit/risk profile of
15
(MDD)
要求检查表
the addition of the substance in the medical device. N.A / The device does not include /
如果器械整合的辅助物质发生了变更，特别是关系到其生 medicinal materials
产过程，公告机构应被通知并向相关的药品主管当局
（也就是最初的咨询机构）咨询，以确认辅助物质的质量
和安全性得以维持。主管当局应考虑公告机构认定的关于
该物质与器械整合有效性的数据，以确保这种变更对已经
建立的医疗器械中的增加物质的临床受益/风险特性没有负
面影响。
When the relevant medicines competent authority (i.e. the

one involved in the initial consultation) has obtained
information on the ancillary substance, which could have
an impact on the established benefit/risk profile of the
addition of the substance in the medical device, it shall
provide the notified body with advice, whether this
information has an impact on the established benefit/risk
profile of the addition of the substance in the medical
device or not. The notified body shall take the updated
scientific opinion into account in reconsidering its
assessment of the conformity assessment procedure.
当相关的药品主管当局（也就是最初的咨询机构）得到关
于辅助物质对已经建立的医疗器械中的增加物质的临床受
益/风险特性有影响的信息后，应向公告机构提出建议，该
信息是否影响已经建立的医疗器械中增加物质的临床受益/
风险特性。公告机构应考虑到更新的科学意见，以重新考
虑对符合性评价程序的评价。
EN ISO14971:2012 Risk management report
7.5 The devices must be designed and manufactured in such A (AB/CE01-06)
Technology
a way as to reduce to a minimum the risks posed by Dept .records
IEC 60601-1: 2005+A1:2012 Product test report No. cabinet
substances leaking from the device. Special attention
shall be given to substances which are carcinogenic, (7019818140301-11-0)
IEC 60601-1-2: 2014 (7019818140301-12-0)
mutagenic or toxic to reproduction, in accordance with ENISO80601-2-69:2014 (SET2019-06911)
Annex I to Council Directive 67/548/EEC2 of 27 June EN 60601-1-8:2014 (SET2019-06912)
2
Internal note: replaced by (EC) 1272/2008
16
(MDD)
要求检查表
1967 on the approximation of laws, regulations and
administrative provisions relating to the classification,
N. / The device does not
A administer medicines /
packaging and labelling of dangerous substances3.
器械的设计和制造，必须将源自器械的物质泄漏的风
险降至最低。应当特别注意按 1967 年 6 月 27 日成员国法
律中 67/548/EEC2 委员会指令附录 I 界定的致癌物、诱基
因突变物和生殖毒性物质相关的危险物质 3 对分类、包装
和标签的法律法规，行政条款的符合。
If parts of a device (or a device itself) intended to
administer and/or remove medicines, body liquids or
other substances to or from the body, or devices intended
for transport and storage of such body fluids or
substances, contain phthalates which are classified as
carcinogenic, mutagenic or toxic to reproduction, of
category 1 or 2, in accordance with Annex I to Directive
67/548/EEC, these devices must be labelled on the
device itself and/or on the packaging for each unit or,
where appropriate, on the sales packaging as a device
containing phthalates.
如果器械的一部分（或器械本身）预期用于对身体给
药或除药、体液或其它物质，或预期用于运输或存储这些
体液或物质，包含有按 67/548/EEC2 指令附录 I 界定的 1
类或 2 类致癌物、诱基因突变物或生殖毒性物质的邻苯二
甲酸盐，该器械必须在自身和/或每台的包装上作出标识，
及适当时在器械的销售包装上作出含有邻苯二甲酸盐的标
识。
If the intended use of such devices includes treatment of

children or treatment of pregnant or nursing women, the
manufacturer must provide a specific justification for the
use of these substances with regard to compliance with
the essential requirements, in particular of this paragraph,
3
within the technical documentation and, within the
OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).
17
(MDD)
要求检查表
instructions for use, information on residual risks for these
patient groups and, if applicable, on appropriate
precautionary measures.
如果器械的预期用途包括对儿童、孕妇或哺乳期妇女
的治疗，制造商必须在技术文档和使用说明书中提供具体
的使用这些物质的理由，及关于对这些患者群的残留风
险，如适用，和合适的防范措施等信息，以符合基本要
求，特别是本条的要求。
7.6 The devices must be designed and manufactured in such A EN ISO14971:2012 (AB/CE01-06) Technology
a way as to reduce as much as possible, risks posed by Dept .records
the unintentional ingress of substances into the device
IEC 60601-1: 2005+A1:2012 Product test report No. cabinet
taking into account the device and the nature of the IEC 60601-1-2: 2014 (7019818140301-11-0)
(7019818140301-12-0)
environment in which it is intended to be used. ENISO80601-2-69:2014 (SET2019-06911)
考虑到器械和预期使用的环境，器械的设计和生产必 EN 60601-1-8:2014 (SET2019-06912)
须保证，最大限度地降低由于异物进入而造成危害的可能
性。
8. Infection and microbial contamination

感染和微生物污染
8.1 The devices and their manufacturing processes must be A

ENISO13485:2016 ENISO13485:2016 certificate Technology
designed in such a way as to eliminate or reduce as far Instruction for use Dept .records
EN1041:2008
as possible the risk of infection to the patient, user and （ABS-DT-UM-01） cabinet
EN ISO14971:2012
third parties. The design must allow easy handling and, Risk management report
where necessary, minimise contamination of the device IEC 60601-1: 2005+A1:2012 (AB/CE01-06)
by the patient or vice versa during use. IEC 60601-1-2: 2014 Product test report No.:
器械设计和制造工艺应当保证最大限度地降低甚至避 ENISO80601-2-69:2014 (7019818140301-11-0)
免患者、使用者和其他人员之间交叉感染的可能性；器械 EN 60601-1-8:2014 (7019818140301-12-0)
(SET2019-06911)
应当操作简单，必要时，减少患者对器械、器械对患者的 (SET2019-06912)
接触污染。 EN62366-1:2015
EN 60601-1-6: 2010 Usability report
+A1:2015 （AB/CE01-12）
8.2 Tissues of animal origin must originate from animals that

have been subjected to veterinary controls and
(MDD)
要求检查表
surveillance adapted to the intended use of the tissues. N.A / /
动物源组织必须从对按组织的预期用途被进行控制和监 The device does not use
管的动物中取得。 tissues of animal origin
Notified Bodies shall retain information on the
geographical origin of the animals.
公告机构应保留动物的原生地的信息。
Processing, preservation, testing and handling of tissues,

cells and substances of animal origin must be carried out
so as to provide optimal security. In particular safety with
regard to viruses and other transmissible agents must be
addressed by implementation of validated methods of
elimination or viral inactivation in the course of the
manufacturing process.
对动物组织、细胞和其它动物源物质的加工、贮存、
检验和处理，必须提供最可靠的安全保障。特别是病毒和
其它传染物质的安全，在生产过程中有采取有效的消除方
法或进行病毒灭活。
N/A / The device is not sterile /

8.3 Devices delivered in a sterile state must be designed,
manufactured and packed in a non-reusable pack and/or device
according to appropriate procedures to ensure they are
sterile when placed on the market and remain sterile,
under the storage and transport conditions laid down,
until the protective packaging is damaged or opened.
无菌器械的设计、生产和包装应采用一次性使用包装
方式，并且在一定工作程序下保证器械上市时处于无菌状
态，在贮藏、运输条件下只要包装不破损或开封，能够保
持无菌状态。
ENISO80601-2-69:2014 Report test No.

8.4 Devices delivered in a sterile state must have been A Technology
201.11.6.7
manufactured and sterilized by an appropriate, validated Dept .records
(SET2019-06911) cabinet
19
(MDD)
要求检查表
method.
无菌器械必须通过专门、有效的方法进行生产和灭菌。
N/A / The device is not sterile /

8.5 Devices intended to be sterilised must be manufactured
in appropriately controlled (e.g. environmental) device
conditions.
需要灭菌的器械在专门控制的环境下生产。
N/A / The device does not need /

8.6 Packaging systems for non-sterile devices must keep the
product without deterioration at the level of cleanliness normally internal packaging
stipulated and, if the devices are to be sterilised prior to system
use, minimise the risk of microbial contamination. The
packaging system must be suitable taking account of the
method of sterilisation indicated by the manufacturer.
非灭菌器械的包装系统，应当保证产品达到规定的清洁
度。如果器械需要在使用前灭菌，应减少器械灭菌前微生
物污染的可能性。包装系统必须适合于制造商所指定的灭
菌方式。
N/A / The device does not need /

8.7 The packaging and/or label of the device must distinguish
between identical or similar products sold in both sterile normally internal packaging
and non-sterile condition. system
相同或相似的产品销售时处于无菌状态还是非无菌状
态，器械必须具有不同的包装和/或标签。
9. Construction and environmental properties

结构和环境特征
EN ISO14971:2012
9.1 If the device is intended for use in combination with other A
EN1041:2008 Risk management report
devices or equipment, the whole combination, including (AB/CE01-06) Technology
the connection system must be safe and must not impair EN62366-1:2015 Instruction for use Dept .records
the specified performance of the devices. Any restrictions EN 60601-1-6: 2010 （ABS-DT-UM-01） cabinet
on use must be indicated on the label or in the instruction +A1:2015 Usability report
（AB/CE01-12）
for use.
20
(MDD)
要求检查表
器械如果需要同其它器械或设备配合在一起使用，整 ENISO80601-2-69:2014 Product test report No.:
(7019818140301-11-0)
个系统应保证安全，包括联接系统必须安全，不得改变器
EN ISO 10993-5:2009 Bio-compatibility
械的预定功能。必须在使用说明或标签上注明使用限制。 ISO10993-10:2010 Certificate(suppliers)
9.2 Devices must be designed and manufactured in such a

way as to remove or minimise as far as possible:
器械的设计和生产必须尽可能降低或避免：
the risk of injury, in connection with their physical

ENISO13485:2016 ENISO13485:2016 certificate
features, including the volume/pressure ratio,
dimensional, and where appropriate the ergonomic EN ISO14971:2012 (AB/CE01-06)
features,
由于器械物理性能特性，如体积压力比、外观尺 Product test report No.:
IEC 60601-1: 2005+A1:2012 (7019818140301-11-0)
寸、人体工学，对人体造成伤害的可能性。 (7019818140301-12-0)
IEC 60601-1-2: 2014
(SET2019-06911)
risks connected with reasonably foreseeable ENISO80601-2-69:2014 (SET2019-06912) Technology
environmental conditions, such as magnetic fields, Dept .records
EN 60601-1-8:2014 cabinet
external electrical influences, electrostatic discharge,
pressure, temperature or variations in pressure, and Instruction for use
A EN1041:2008 （ABS-DT-UM-01）
acceleration,
在合理的环境条件下，如电磁场、外部电子干扰， Usability report
静电放射、大气压、气温以及压力变化和加速度等条件 EN62366-1:2015 （AB/CE01-12）
下，对人体造成伤害的可能性。 EN 60601-1-6: 2010
the risks of reciprocal interference with other +A1:2015
devices normally used in the investigations or for the
treatment given,
在治疗或试用时，同其它器械相互干扰对人体造成
伤害的可能性。
risks arising where maintenance or calibration

are not possible (as with implants) from ageing of the
materials used or loss of accuracy of any measuring or
control mechanism.
21
(MDD)
要求检查表
如果无法维修或矫正(如植入人体后),由于材料老
化、测试或控制机能精度不够，对人体造成伤害的可能
性。
9.3 Devices must be designed and manufactured in such a A Technology
Risk management report Dept .records
way as to minimise the risks of fire or explosion during EN ISO14971:2012 (AB/CE01-06)
cabinet
normal use and in single fault condition. Particular
attention must be paid to devices whose intended use IEC 60601-1: Product test report No.:
includes exposure to flammable substances which could (7019818140301-11-0)
2005+A1:2012 (7019818140301-12-0)
cause combustion. IEC 60601-1-2: 2014 (SET2019-06911)
ENISO80601-2-69:2014 (SET2019-06912)
器械的设计和生产必须保证，在正常使用情况下或单
EN 60601-1-8:2014 Instruction for use
一故障的情况下，器械不至于起火或爆炸。对在暴露于易（ABS-DT-UM-01）
燃物质环境下使用的器械必须给予特别注意。 EN1041:2008 Usability report
EN62366-1:2015 （AB/CE01-12）
EN 60601-1-6: 2010
+A1:2015
10. Devices with a measuring function
具有测量功能的器械
ENISO80601-2-69:2014 Test report No.:
10.1 Devices with a measuring function must be designed and A (SET2019-06911)
Technology
201.12.1, 201.102
manufactured in such a way as to provide sufficient Dept .records
cabinet
accuracy and stability within appropriate limits of
accuracy and taking account of the intended purpose of
the device. The limits of accuracy must be indicated by
the manufacturer.
检测器械的设计和生产必须保证足够的精度和稳定
性、符合器械预定功能的要求。制造商必须注明其精度范
围。
ENISO80601-2-69:2014 201.7, Test report No.:
10.2 The measurement, monitoring and display scale must be A (SET2019-06911)
Technology
201.102.1,206,208
designed in line with ergonomic principles, taking account Dept .records
cabinet
of the intended purpose of the device.
必须根据器械的预定功能，按照人体工学的原理设计
器械的度量、监控和显示刻度。
22
(MDD)
要求检查表
ENISO80601-2-69:2014 Test report No.:
10.3 The measurements made by devices with a measuring A (SET2019-06911)
Technology
201.7.4.3
function must be expressed in legal units conforming to Dept .records
Instruction for use
Directive 80/181/EEC （ABS-DT-UM-01）
cabinet
the provisions of Council Directive 80/181/EEC4.
测量器械必须使用法定度量单位，符合理事会法令
80/181/EEC4 的规定。
11. Protection against radiation

辐射保护
General N/A / No radiation /

11.1
原则
11.1.1
Devices shall be designed and manufactured such that
exposure of patients, users and other persons to radiation
shall be reduced as far as possible compatible with the
intended purpose, whilst not restricting the application of
appropriate specified levels for therapeutic and diagnostic
purposes.
器械的设计和生产必须保证在达到预定功能的情况
下，尽量减少对患者、使用者和其它人员的辐射，但不限
制为治疗和诊断疾病使用规定合理的剂量。
Intended radiation / No radiation /

11.2 N/A
预期的辐射
11.2.1
Where devices are designed to emit hazardous levels of
radiation necessary for a specific medical purpose the
benefit of which is considered to outweigh the risks
inherent in the emission, it must be possible for the user
to control the emissions. Such devices shall be designed
and manufactured to ensure reproducibility and tolerance
of relevant variable parameters.
用于特定医疗目的，有的器械辐射危害人体健康的射
4
OJ No L 39, 15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357, 7. 12. 1989, p. 28).
23
(MDD)
要求检查表
线，这种器械对患者的治疗作用同射线相比可以为人们所
接受。器械辐射剂量必须能够控制，(设计和生产时)必须
考虑其可变参数的可重复性和容差。
N/A / No radiation /
11.2.2 Where devices are intended to emit potentially
hazardous, visible and/or invisible radiation, they must be
fitted, where practicable, with visual displays and/or
audible warnings of such emissions.
设计器械发射危害性射线，不论射线是否可见，都应
根据实际需要安装可见的显示装置和发声的报警装置，指
示射线的发射状态。
Unintended radiation N/A / No unintended radiation /

11.3
非预期的辐射
11.3.1
Devices shall be designed and manufactured in such a
way that exposure of patients, users and other persons to
the emission of unintended, stray or scattered radiation is
be reduced as far as possible.
器械的设计和制造应当保证，尽量减少对患者，使用
者以及其它人员产生非预期的意外辐射。
N/A / No radiation /
11.4 Instructions
11.4.1 使用说明
The operating instructions for devices emitting radiation

must give detailed information as to the nature of the
emitted radiation, means of protecting the patient and the
user and on ways of avoiding misuse and of eliminating
the risks inherent in installation.
放射性医疗器械应详细说明辐射特性、对患者和操作
者的保护措施、任何防止操作错误以及消除由于安装器械
带来的潜在危险。
11.5 Ionising radiation N/A /
24
(MDD)
要求检查表
电离辐射 N/A / The device is not /
11.5.1
Devices intended to emit ionising radiation must be
designed and manufactured in such a way as to ensure intended for ionising radiation
that, where practicable, the quantity, geometry and quality function
of radiation emitted can be varied and controlled taking
into account the intended uses.
电离辐射器械的设计和生产必须保证，可以改变和控
制电离辐射的数量，形状和质量，满足预定使用功能的实
际需要。
Devices emitting ionising radiation intended for diagnostic N/A / The device is not intended /
11.5.2
radiology shall be designed and manufactured in such a for diagnostic radiology
way, as to achieve appropriate image and/or output function
quality for the intended medical purpose whilst minimising
radiation exposure of the patient and user.
诊断用电离辐射器械的设计和生产必须保证，在获得
清晰图象、提高输出质量、达到预定医疗目的的情况下，
尽量减少对患者和使用者的照射。
Devices emitting ionising radiation intended for N/A / The device is not /
11.5.3
therapeutic radiology shall be designed and
manufactured in such a way as to enable reliable intended for ionising radiation
monitoring and control of the delivered dose, the beam function
type and energy and where appropriate the quality of the
radiation.
治疗用电离辐射器械的设计和生产必须保证，能够有
效地监控照射剂量、离子束类型、能量大小以及离子束的
质量。
12. Requirements for medical devices connected to or

equipped with an energy source
连接或配备能源的医疗器械的要求
Devices incorporating electronic programmable systems IEC 60601-1: 2005+A1:2012 Product test report No.:
12.1 A (7019818140301-11-0)
Technology
must be designed to ensure the repeatability, reliability ENISO80601-2-69:2014 (SET2019-06911) Dept .records
and performance of these systems according to their cabinet
25
(MDD)
要求检查表
intended use. In the event of a single fault condition (in
the system) appropriate means should be adopted to
eliminate or reduce as far as possible consequent risks
带有可编程系统的器械设计应保证其可重复性、可靠
性、满足预定功能的需要。应当采取必要措施、减少因出
现单一故障状态而造成危害的可能性。
For devices which incorporate software or which are ENISO80601-2-69:2014, 201.14 Product test report No.:
12.1a A (SET2019-06911)
/
medical software in themselves, the software must be
validated according to the state of the art taking into Software Validation
account the principles of development lifecycle, risk EN 62304:2006/AC:2008 Report
management, validation and verification. （AB/CE01-13）
对于合并软件使用的或本身是医疗软件的器械，软件
必须考虑研发生命周期、风险管理、确认和验证的原则，
按照当前的技术发展水平进行确认。
Devices where the safety of the patients depends on an N/A / The device no internal power /
12.2
internal power supply must be equipped with a means of supply
determining the state of the power supply.
对维系患者安全的器械，内部供电时，应配有电源指
示装置，表明电源的供电状况。
Devices where the safety of the patient depends on an N/A / The device does not /
12.3
external power supply must include an alarm system to intended use to maintain the
signal any power failure. safety of patient
对维系患者安全的器械，外部供电时，应增加报警装
置，报告电源中断。
N/A / The device is not intended to /

12.4 Devices intended to monitor one or more clinical
parameters of a patient must be equipped with monitor one or more clinical
appropriate alarm systems to alert the user of situations parameters
which could lead to death or severe deterioration of the
patient's state of health.
监测患者临床数据的器械，必须配置相应的报警系
统，提醒操作者可能导致患者死亡或病情严重恶化的情
况。
26
(MDD)
要求检查表
Devices must be designed and manufactured in such a ENISO13485:2016 ENISO13485:2016 certificate
12.5 A Technology
way as to minimise the risks of creating electromagnetic Risk management report Dept .records
EN ISO14971:2012 (AB/CE01-06)
fields which could impair the operation of other devices or cabinet
equipment in the usual environment. Product test report No.:
IEC 60601-1-2: 2014
器械的设计和生产必须保证，尽量减少由于产生电磁 (7019818140301-12-0)
ENISO80601-2- (SET2019-06911)
场，影响其它器械或设备的操作使用造成的危害。 69:2014
Protection against electrical risks ENISO13485:2016 ENISO13485:2016 certificate

12.6 A Technology
防止触电危险. Risk management report Dept .records
EN ISO14971:2012 (AB/CE01-06)
Devices must be designed and manufactured in such a cabinet
way as to avoid, as far as possible, the risk of accidental IEC 60601-1: 2005+A1:2012 Product test report No.:
electric shocks during normal use and in single fault (7019818140301-11-0)
ENISO80601-2-69:2014 (SET2019-06911)
condition, provided that the devices are installed
correctly.
假定器械安装正确，器械的设计和生产必须尽量减少
在正常使用和出现单一故障时，意外电击的危险。
Protection against mechanical and thermal risks ENISO13485:2016 ENISO13485:2016 certificate

12.7 A Technology
高温和机械防护 Risk management report Dept .records
EN ISO14971:2012 (AB/CE01-06)
12.7.1 cabinet
Devices must be designed and manufactured in such a
way as to protect the patient and user against mechanical IEC 60601-1: Product test report No.:
risks connected with, for example, resistance, stability (7019818140301-11-0)
2005+A1:2012 (SET2019-06911)
and moving parts. ENISO80601-2-69:2014
器械的设计和生产必须保证患者、使用者不受机械部
件造成的损伤，如阻力部件、稳定性部件和移动性部件造
成的损伤。
Devices must be designed and manufactured in such a ENISO13485:2016 ENISO13485:2016 certificate

12.7.2 A Technology
way as to reduce to the lowest possible level the risks EN ISO14971:2012 Risk management report Dept .records
(AB/CE01-06)
arising from vibration generated by the devices, taking cabinet
IEC 60601-1: 2005
account of technical progress and of the means available +A1:2012 Product test report No.:
for limiting vibrations, particularly at source, unless the ENISO80601-2-69:2014 (7019818140301-11-0)
vibrations are part of the specified performance. (SET2019-06911)
器械的设计和生产必须保证，根据技术发展水平，采
27
(MDD)
要求检查表
取控制振动(特别是振动源)的措施，最大限度地降低器械
振动造成的危害，除非所发出的振动是特定功能的需要。
Devices must be designed and manufactured in such a EN ISO14971:2012 Risk management report
12.7.3 A (AB/CE01-06)
Technology
way as to reduce to the lowest possible level the risks Dept .records
arising from the noise emitted, taking account of technical IEC 60601-1: cabinet
2005+A1:2012 Product test report No.:
progress and of the means available to reduce noise, (7019818140301-11-0)
ENISO80601-2-69:2014 (SET2019-06911)
particularly at source, unless the noise emitted is part of
the specified performance.
器械的设计和生产必须保证，根据技术发展水平，采
取控制噪音(特别是噪音源)的措施，最大限度地降低器械
噪音造成的危害，除非所发出的声音是特定功能的需要。
The terminals and connectors to the electricity, gas or EN ISO14971:2012 Risk management report
12.7.4 A (AB/CE01-06)
Technology
hydraulic and pneumatic energy supplies which the user IEC 60601-1: Dept .records
has to handle must be designed and constructed in such 2005+A1:2012 cabinet
ENISO80601-2-69:2014 Product test report No.:
a way as to minimise all possible risks. (7019818140301-11-0)
操作者接触的电源、气动、气压端口和连接件，设计 (SET2019-06911)
和生产必须考虑减少各种危险的可能性。
Accessible parts of devices (excluding any parts or areas EN ISO14971:2012 Risk management report
12.7.5 A (AB/CE01-06)
Technology
intended to supply heat or reach given temperatures) and IEC 60601-1: Dept .records
their surroundings must not attain potentially dangerous 2005+A1:2012 cabinet
temperatures under normal use. (7019818140301-11-0)
在正常使用的情况下，人体可接触到的器械部件及其 (SET2019-06911)
周围，温度不得过高，以免造成危险；但不包括专门用于
提供热量或必须达到一定温度的部件和区域。
12.8 Protection against the risks posed to the patient by A Technology
EN ISO14971:2012 Risk management report Dept .records
energy supplies or substances (AB/CE01-06)
cabinet
防止能源提供和物资供应造成对患者的危险 IEC 60601-1: 2005+A1:2012
12.8.1 Devices for supplying the patient with energy or (7019818140301-11-0)
substances must be designed and constructed in such a (SET2019-06911)
way that the flow rate can be set and maintained
accurately enough to guarantee the safety of the patient
and of the user.
28
(MDD)
要求检查表
为患者提供能源或物质的器械设计和生产必须保证，
器械可以控制流量，保证足够的精度，保证患者和使用者
的安全。
Devices must be fitted with the means of preventing ENISO13485:2016 ENISO13485:2016 certificate
12.8.2 N/A Technology
and/or indicating any inadequacies in the flow-rate which EN ISO14971:2012 Risk management report Dept .records
(AB/CE01-06)
could pose a danger. cabinet
器械必须配有专门装置，防止出现流量波动给患者带 IEC 60601-1: Product test report No.:
来危险，或出现问题时报警。 2005+A1:2012 (7019818140301-11-0)
ENISO80601-2-69:2014 (SET2019-06911)
Devices must incorporate suitable means to prevent, as (SET2019-06912)
far as possible, the accidental release of dangerous EN60601-1-8:2014
levels of energy from an energy and/or substance source. Instruction for use
EN1041:2008 （ABS-DT-UM-01）
器械必须配备适当的装置尽量避免能量和/或物质意外
增加到危险的程度。
The function of the controls and indicators must be clearly ENISO13485:2016 ENISO13485:2016 certificate
12.9 A Technology
specified on the devices. 指示器和控制按钮、手柄等必须 EN ISO14971:2012 Risk management report Dept .records
(AB/CE01-06)
在器械上予以注明。 Where a device bears instructions cabinet
required for its operation or indicates operating or IEC 60601-1: Product test report No.:
adjustment 2005+A1:2012 (7019818140301-11-0)
(SET2019-06911)
parameters by means of a visual system, such
ENISO80601-2-
information must be understandable to the user and, as
69:2014
appropriate, the patient. Instruction for use
（ABS-DT-UM-01）
如果器械通过可视系统提供操作说明，通过可视系统 EN1041:200
显示和修改各种参数，可视系统显示的信息必须能为操作
EN62366-1:2015 Usability report
者所理解，必要时患者也应看得懂。（AB/CE01-12）
EN 60601-1-6: 2010
+A1:2015
13. Information supplied by the manufacturer

制造商提供的信息
Each device must be accompanied by the information ENISO15223-2016 Label

13.1 （AB/CE01-08/03）
needed to use it safely and properly, taking account of the EN1041:2008
Instruction for use
training and knowledge of the potential users, and to A EN62366-1:2015\ （ABS-DT-UM-01）
identify the manufacturer. EN 60601-1-6: 2010 Usability report
考虑到对于潜在使用者的培训和认知，以及识别制造 +A1:2015 （AB/CE01-12）
29
(MDD)
要求检查表
商，每个器械必须附带所需信息，以安全正确使用。 ENISO80601-2- Product test report No.:
69:2014 ,201.7,201.11.6.4 (SET2019-06911)
This information comprises the details on the label and
the data in the instructions for use.
这些信息器械应在标签或使用说明书具体说明。
As far as practicable and appropriate, the information
needed to use the device safely must be set out on the
device itself and/or on the packaging for each unit or,
where appropriate, on the sales packaging. If individual
packaging of each unit is not practicable, the information
must be set out in the leaflet supplied with one or more
devices.
根据实际需要，在器械上、在每个器械的包装上或在
销售包装上都应注明安全使用所需要的操作信息。如果不
可能对每个器械单独包装，则应随每一个器械或一定数量
的器械提供活页说明。
Instructions for use must be included in the packaging for
every device. By way of exception, no such instruction
leaflet is needed for devices in Class I or Class IIa if they
can be used completely safely without any such
instructions.
每个器械的包装中应附带使用说明，但 I 类或IIa 类器
械，如果不需要使用说明书也可以安全使用，可以除外。
13.2 Where appropriate, this information should take the form

of symbols. Any symbol or identification colour used must Label
ENISO15223-2016
conform to the harmonised standards. In areas for which （AB/CE01-08/03） Technology
no standards exist, the symbols and colours must be EN1041:2008 Dept .records
described in the documentation supplied with the device. A Instruction for use cabinet
ENISO80601-2-69:2014 （ABS-DT-UM-01）
根据需要应通过使用标志说明操作信息。器械使用的
标志或识别颜色应符合欧洲共同体协调标准。如果没有统
一标准，标志和识别颜色的含义必须在器械附带的资料中
说明。
13.3 The label must bear the following particulars:
30
(MDD)
要求检查表
器械标签必须具有下列内容：
a) the name or trade name and address of the manufacturer. A ENISO15223-2016 Label
Technology
For devices imported into the Community, in view of their EN1041:2008 （AB/CE01-08/03）
Dept .records
distribution in the Community, the label, or the outer ENISO80601-2-69:2014
cabinet
packaging, or instructions for use, shall contain in Instruction for use
addition the name and address of the authorised （ABS-DT-UM-01）
representative where the manufacturer does not have a
registered place of business in the Community; 制造商的
名称或商品名以及地址。为了在欧洲共同体内销售，如果
制造商在欧共体内没有注册场地，则进口的器械标签、
或外包装或使用说明书中应另外注明授权代表的名称和
地址。 Label
ENISO15223-2016 （AB/CE01-08/03） Technology
EN1041:2008 Dept .records
b) the details strictly necessary to identify the device and
ENISO80601-2-69:2014 cabinet
the contents of the packaging especially for the users; Instruction for use
A
使用者识别器械和了解包装内容必需的信息；（ABS-DT-UM-01）
c) where appropriate, the word "STERILE";

N/A / Not sterile device
必要时，注明“已灭菌”字样；
/
d) where appropriate, the batch code, preceded by the
ENISO15223-1:2016 Label （AB/CE01-08/03） Technology
word "LOT", or the serial number; A Dept .records
EN1041:2008 Instruction for use
必要时，注明批号或系列号，批号以“LOT”打头； ENISO80601-2-69:2014 （ABS-DT-UM-01） cabinet
e) where appropriate, an indication of the date by which

ENISO15223-1:2016 Technology
the device should be used, in safety, expressed as the A Label （AB/CE01-08/03）
year and month; Instruction for use
（ABS-DT-UM-01）
cabinet
必要时，注明器械安全使用的期限，以年和月表示。
f) where appropriate, an indication that the device is for N/A /

the device is
not for single use. /
single use. A manufacturer’s indication of single use
must be consistent across the Community;
必要时，注明器械属于一次性使用。制造商的一次性使
31
(MDD)
要求检查表
用标识必须在欧共体内统一。
/ the device is not custom made
g) if the device is custom made, the words "custom made N/A /
device";
如果属于定作器械，注明“定制器械”字样。
the device is not intended for
h) if the device is intended for clinical investigations, the N/A clinical investigations /
/
words "exclusively for clinical investigations";
如果属于临床试用的器械，注明“专门用于临床研究” 字
样
i) any special storage and/or handling conditions; A ENISO15223-1:2016 Technology

Label （AB/CE01-08/03）
特殊储存条件和/或管理要求； ENISO80601-2-69:2014
Instruction for use cabinet
（ABS-DT-UM-01）
Technology
j) any special operating instructions;
Dept .records
Label （AB/CE01-08/03）
特殊操作说明； A ENISO15223-1:2016 cabinet
EN1041:2008 Instruction for use
ENISO80601-2-69:2014 （ABS-DT-UM-01）
k) any warnings and/or precautions to take;
任何警告和/或注意事项
A EN1041:2008 Instruction for use Technology
l) year of manufacture of active devices other than those （ABS-DT-UM-01）
ENISO80601-2-69:2014 Dept .records
covered by e). This indication may be included in the cabinet
batch or serial number; A EN1041:2008 Instruction for use Technology
（ABS-DT-UM-01） Dept .records
有源器械的生产年份，如不为(e)项所含，则也可以
cabinet
包含在批号或系列号内。
m) where applicable, method of sterilization.

如适用，注明灭菌方法。
N/A / Not sterile device /
n) in the case of a device within the meaning of Article
N/A / /
1(4a), an indication that the device contains a human the device not contains a
blood derivative." human blood derivative
若器械涉及第一章1(4a)条款，注明器械含有人血制品
32
(MDD)
要求检查表
13.4 If the intended purpose of the device is not obvious to the Technology
user, the manufacturer must clearly state it on the label Dept .records
ENISO15223-1:2016 Instruction for use
and in the instructions for use. A cabinet
（ABS-DT-UM-01）
如果器械的预定功能对操作者来说不是显而易见的，
制造商在标签和说明书上应当加以清楚阐述。
13.5 Wherever reasonable and practicable, the devices and Technology

detachable components must be identified, where Dept .records
ENISO15223-1:2016 Instruction for use
appropriate in terms of batches, to allow all appropriate cabinet
（ABS-DT-UM-01）
action to detect any potential risk posed by the devices
A
and detachable components.
当合理和可行时，器械和可拆卸部件必须加以识别，
就批量而言，可以采取各种有效方法对器械和拆卸部件带
来的潜在风险加以识别。
13.6 Where appropriate, the instructions for use must contain

the following particulars:
若适用，使用说明书必须包含以下说明：
a) the details referred to in 13.3, with the exception of d) A ENISO15223-1:2016 Label （AB/CE01-08/03） Technology
and e) EN1041:2008 Instruction for use Dept .records
（ABS-DT-UM-01） cabinet
本附录第13.3 款所指除(d)和(e)项以外的各项内容；
Technology
b) the performances referred to in section 3 and any A ENISO15223-1:2016 Label （AB/CE01-08/03） Dept .records
undesirable side effects; EN1041:2008 Instruction for use cabinet
本附录第3 款所指使用性能及其可能带来的副作用。（ABS-DT-UM-01）
c) if the device must be installed with or connected to

other medical devices or equipment in order to operate
as required for its intended purpose, sufficient details
of its characteristics to identify the correct devices or The device is used independently
equipment to use in order to obtain a safe N/A /
combination;
如果必须同其它器械或设备一同安装或连接使用，应
当详细说明配合使用的器械或设备的特性，以便取得预
33
(MDD)
要求检查表
期的功能。 EN1041:2008 Instruction for use
（ABS-DT-UM-01） Technology
d) all the information needed to verify whether the device A
Dept .records
is properly installed and can operate correctly and cabinet
safely, plus details of the nature and frequency of the
maintenance and calibration needed to ensure that the
devices operate properly and safely at all times;
鉴别器械是否正确安装所必要的技术信息，保证准
确、安全使用；以及维护和校准器械所必须的技术指标
或频率，保证器械长期准确、安全使用的所有信息。
/
e) where appropriate, information to avoid certain risks in N/A
connection with implantation of the device;
对植入人体的器械，如果需要，应加以特别说明，避
免出现植入人体器械特有的危险。
Not a implantation device /
f) information regarding the risks of reciprocal interference
posed by the presence of the device during specific N/A
investigations or treatment;
在进行特定检查和治疗的过程中，器械产生相互干扰
的危险性说明。
/
N/A
g) the necessary instructions in the event of damage to
the sterile packaging and, where appropriate, details
of appropriate methods of re-sterilisation No specific investigations or
说明灭菌包装损坏后，器械如何进行处理；如果可 treatment
能，说明重新灭菌的有效方法。 N/A
h) if the device is reusable, information on the appropriate

/
processes to allow reuse, including cleaning,
disinfection, packaging and, where appropriate, the
method of sterilization of he device to be resterilized,
and any restriction on the number if reuses. Not sterile device
Where devices are supplied with the intention that they
be sterilized before use, the instructions for cleaning
34
(MDD)
要求检查表
and sterilization must be such that, if correctly
followed, the device will still comply with the
requirements in Section I).
If the device bears an indication that the device is for
single use, information on known characteristics and
technical factors known to the manufacturer that could
pose a risk if the device were to be re-used. If in
accordance with Section 13.1 no instructions for use
are needed, the information must be made available to
the user upon request;
可重复使用的器械，应说明准确使用的方法，包括清
洁、消毒、包装以及，如适用，对需要再次灭菌器械进行
灭菌的方法，重复使用的次数限制。如果器械预期要在使
用前灭菌，按照清洁和灭菌的使用说明书要求正确执行，
器械仍符合第1 部分的要求。如果器械附带了一次性使用
的标识，制造商已知的由于已知特性以及技术因素使器械
重复使用带来风险的信息。如果按13.1 部分的规定不需
要使用说明书，则信息必须应使用者要求而提供。
i) details of any further treatment or handling needed

before the device can be used (for example, N/A /
sterilisation, final assembly, etc.)
器械使用前如何进行处理，如灭菌、最后组装等；
j) in the case of devices emitting radiation for medical /

purpose, details of the nature, type intensity and
N/A
distribution of this radiation
利用放射线治疗的器械，必须说明放射线的特性、类
型、密度和分布
The instruction for use must also include details, allowing /
the medical staff to brief the patient on any contra-
N/A
indications and any precautions to be taken. These
details should cover in particular:
Not sterile device
35
No emitting radiation
(MDD)
要求检查表
使用说明书必须另外说明，医护人员如何向消患者说
明禁忌症和注意事项，具体包括： Technology
ENISO15223-1:2016 Label （AB/CE01-08/03） Dept .records
k) precautions to be taken in the event of changes in
A EN1041:2008 Instruction for use cabinet
the performance of the device; （ABS-DT-UM-01）
器械性能发生变化时的注意事项；
l) precautions to be taken as regards exposure, in A EN1041:2008 Instruction for use
reasonably foreseeable environmental conditions, to （ABS-DT-UM-01）
magnetic fields, external electrical influences, Technology
electrostatic discharge, pressure or variations in Dept .records
pressure, acceleration, thermal ignition sources etc.; cabinet
在可预见的使用环境下，在电磁场、外界电流、静电
放射、大气压以及大气压发生变化、加速度、热力源等
作用下，应当采取的注意事项 The device does not load
m) adequate information regarding the medicinal
Other materials /
product or products which the device in question is
designed to administer, including any limitations in the
N/A
choice of substances to be delivered;
应当详细说明器械加载的药品或其它物质的性能，
包括其选择物质的限制范围； Instruction for use Technology
n) precautions to be taken against any special, unusual A
risks related to the disposal of the device; cabinet
处置器械时防止出现特别、意外风险的注意事项。
o) medicinal substances, or human blood derivatives
incorporated into the device as an integral part in The device does not load
accordance with Section 7.4;
N/A /
说明第7.4 款所指同器械结合一体使用的药物或人血 Other materials
制品；
p) degree of accuracy claimed for devices with a
measuring function. No measuring function
具有测试功能的器械应说明声称的精度。
N/A /
q) date of issue or the latest revision of the instructions EN1041:2008
for use.
Instruction for use Technology
使用说明书最新版本或修订日期
A （ABS-DT-UM-01） Dept .records
cabinet
36
3. Description and Features
3.1) A complete description
The oxygen concentrator is composed of an oxygen concentrator main machine (including an air compressor, a molecular sieve tower, filters and a master
board), a flow meter and a humidifier
This product is suitable for oxygen-deficient patients and places where lack of centralized oxygen supply of medical units for oxygen therapy or oxygen health
care.
Warning: Use under the doctor's advice on oxygen inhalation time, oxygen flow, nebulize and need for humidification.
3.2) The principle:
This machine uses AC220V power source as the power source, air as raw material and high quality molecular sieve to make high purity oxygen which meets
medical oxygen standard by normal Pressure Swing Adsorption method (PSA method) at normal temperature.
3.3) Classification（Risk Class and Conformity Routes）
Risk-based classification: Class B
Classification－ According to the Annex IX of MDD93/42/EEC, Rules 11, the product is subject to: Class Ⅱa
(All active therapeutic devices intended to administer or exchange energy are in Class Ⅱa)
Conformity Routes－ MDD93/42/EEC Annex Ⅴ(Production quality assurance system)
3. 4) A description of the accessories
This product provides oxygen by oxygen tube, humidifying bottle and cannula or oxygen headset for oxygen breathing.
4.Intended use
This product is suitable for oxygen-deficient patients and places where lack of centralized oxygen supply of medical units for oxygen therapy or oxygen health
care.
Warning: Use under the doctor's advice on oxygen inhalation time, oxygen flow, nebulize and need for humidification.
37
5.Indications of use
1. Respiratory diseases, pneumonia, bronchitis, chronic bronchitis, viral respiratory tract infection, asthma emphysema, pulmonary heart disease, etc.
2. Cardiovascular and cerebrovascular diseases: hypertension, heart disease, coronary heart disease, myocardial infarction, cerebral ischemia, cerebral dizziness.
Atherosclerosis.
3. Plateau hypoxia, plateau pulmonary edema, acute mountain sickness, and chronic mountain sickness. Plateau coma, altitude hypoxia and so on.
4. vulnerable to hypoxia: the elderly, pregnant women, long-term engaged in intellectual work of students, company staff, cadres, long-term engaged in
underground or confined space operations. People who are overworked and don't have enough oxygen.
5. Other people who need oxygen therapy, those who are weak and sickly, those with poor immunity, those suffering from gas poisoning and drug poisoning,
etc.
6. Instructions of use on the device

See the Instruction of Use ( user manual)
7.Other relevant Specifications
List of the various configurations
Name of Medical Device Oxygen Concentrator

FAMILY/GROUP/SYSTEM:
Proposed Grouping for Medical Device FAMILY
(FAMILY/GROUP/SYSTEM):
Name as per Device Label Identifier Brief Description of Item

3L Oxygen Concentrator ANGEL-3S, ANGEL-3A Flow rate: 3L per min
5L Oxygen Concentrator ANGEL-5S, ANGEL-5AB, ANGEL-5A Flow rate: 5L per min
10L Oxygen Concentrator ANGEL-10S Flow rate: 10L per min
8.Contraindications
Severe carbon monoxide poisoning patients are prohibited.
Supplemental oxygen is not addictive. This product can be used under the condition of no great dust at room temperature, can not be used for life support.
9.Warnings
See attached the Instruction of Use
38
10.Precautions
See attached the Instruction of Use
11.Potential adverse effects

No adverse effect has been detected for ANGEL-Series Oxygen Concentrator. For the other companies which have the similar products, we check the website
http://www.gdda.gov.cn/ and http://www.sda.gov.cn. There hasn’t any adverse event occur before. Thus there are not significant adverse events over the years,
and thus no need to do field corrective actions.
The medical device does not contains animal or human cells, tissues and/or derivatives thereof, rendered non-viable (e.g. porcine heart valves, catgut sutures,
etc.); cells, tissues and/or derivatives of microbial or recombinant origin (e.g. dermal fillers based on hyaluronic acid derived from the bacterial fermentation
processes); and/or irradiating components, ionizing (e.g. x-ray) or non-ionising (e.g. lasers, ultrasound, etc.).
12. Alternative therapy

The alternative therapy of this device can be: Hospital oxygen supply system, medical grade oxygen cylinder.
13. Materials
The materials direct or indirect contact with the human body is the oxygen cannula only. And this cannula is disposable item with CE mark.
14. Other relevant specifications and descriptive information

Maximum
Maximum Nebulizer
Model No Supply Voltage Input Power Output Noise Rechargeable
Recommend Flow Source
Pressure
ANGEL-20S AC 230V，50Hz ≤1440VA 20L/min±0.5L/min ≤70kPa ≤60dB（A） NO NO
ANGEL-5S AC 230V，50Hz ≤450VA 5L/min±0.5L/min ≤70kPa ≤60dB（A） YES NO
ANGEL-5AB DC 24V ≤350VA 5L/min±0.5L/min ≤70kPa ≤60dB（A） NO YES
ANGEL-5A AC 230V，50Hz ≤450VA 5L/min±0.5L/min ≤70kPa ≤60dB（A） NO NO
39
ANGEL-3S AC 230V，50Hz ≤330VA 3L/min±0.3L/min ≤70kPa ≤60dB（A） YES NO
ANGEL-3A AC 230V，50Hz ≤330VA 3L/min±0.3L/min ≤70kPa ≤60dB（A） NO NO
Remarks:
1. When all models of oxygen concentrators apply a back pressure of 70 kPa at the maximum recommended flow rate, the
flow rate changes ≤ ± 10% of the maximum recommended flow rate.
2. The oxygen concentration at the nominal pressure of all models of oxygen concentrators is 0 (within the initial start-up
within 30min, the specified concentration level is reached): when the oxygen flow rate is ≤ the maximum recommended flow
rate, the oxygen concentration is ≥90% (V/V) ; (above 800 meters above sea level)
3. Oxygen outlet temperature of all models of oxygen concentrators: no more than 6℃ above ambient temperature.
15. Other Descriptive Information
1. When all models of oxygen concentrators apply a back pressure of 70 kPa at the maximum recommended flow rate, the flow rate changes ≤ ± 10% of the
maximum recommended flow rate.
2. The oxygen concentration at the nominal pressure of all models of oxygen concentrators is 0 (within the initial start-up within 30min, the specified
concentration level is reached): when the oxygen flow rate is ≤ the maximum recommended flow rate, the oxygen concentration is ≥90% (V/V) ; (above 800
meters above sea level)
3. Oxygen outlet temperature of all models of oxygen concentrators: no more than 6℃ above ambient temperature.
40
16. Summary of design verification and validation documents
Declarations of conformity to the standards listed and summaries of tests and evaluations
Standard Checklist GB9706.1-2007 Medical Electric Equipment Part 1 - General Requirements of Safety
YY0732-2009 Safety Requipments for Medical Oxygen Concentrator
YY0709-2009 Oxygen concentrators for medical use Part 1-8 —Safety requirements
AngelBiss Product Registration Standard for Medical Oxygen Concentrator
Test Summary The inspected sample test result are conformed to the requirements of Standard Checklist below:
GB9706.1-2007 Medical Electric Equipment Part 1 - General Requirements of Safety
YY0732-2009 Safety Requipments for Medical Oxygen Concentrator
YY0709-2009 Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral
standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
AngelBiss Product Registration Standard for Medical Oxygen Concentrator
Listing of and conclusions drawn from published reports that concern the safety and performance of aspects of the device with reference to the Essential
Principles.
Below safety and performance report is officially issued and published by CFDA (Jiangxi Province Institute for Medical Equipment Testing) which adopts
National Standard #YY0732-2009 Oxygen concentrators for medical use —Safety requirements, and this standard #YY0732-2009 is conformed to EN ISO
8359:2009/A1:2012.
Enterprise Standard for Registration Products
No. Inspection Request Inspection Specific

Result Comments
4.3 General requirements

4.3.1 The appearance and structure
41
4.3.1.1 Oxygen Concentrator appearance should be upright, surface should be smooth, level off, should not have o PASS PASS
bvious concave and convex, bruising, scratches, front edge, burr
4.3.1.2 Description, symbol of Oxygen Concentrator should be clear, correct and firm PASS PASS
4.3.1.3 All operating instructions of Oxygen Concentrator should be correct; operation guide should be flexible and r PASS PASS
eliable. All parts connection should be firm, not loose
4.3.2 Operational Pneumatic Physical Inspection
4.3.2.1 Oxygen≥ 90% (V/V) 93.3% (V/V) PASS
4.3.2.2 Humidity(without humidified) ≤0.07g/m³ 0.02 g/m³ PASS
4.3.2.3 CO2 ≤0.01% (V/V) 9x10-6 (V/V) PASS

4.3.2.4 CO purity
Should comply with GB8982—2009. Article 1 PASS PASS

4.3.2.5 Gaseous acid and alkali
4.3.2.6 Ozone and other Gaseous Oxides
4.3.2.7 Oxygen Should be Odorless PASS PASS

4.3.2.8 Solid material particle size ≤ 10μm <10μm PASS
4.3.2.9 Solid material volume ≤0.5 mg/m³ ≤0.5 mg/m³ PASS
4.4 Performance requirements

4.4.1 Air tightness
All connections are tight and sealed, all gas pipes are correct, the tube hoop should not be loose, no gas PASS PASS
leakage.
4.4.2 The visible” oxygen “indicator
42
After 3 minutes running of the oxygen concentrator, if the oxygen is <82%±2% the red “service required” PASS PASS
light will activate with a high priority audible alarm sounds.
4.4.3 Inner pipes’ Pressure Alarms
When the pressure of the main inner pipes is lower than 40kPa (margin of error: ±10kPa), the red “service 39.3kPa PASS
required” light will activate with a high priority audible alarm sounds.
4.5 Sound level
The oxygen concentrator should run in a steady way and without any abnormal noise. The sound level 53.2dB(A) PASS
should not be more than 60dB (A)
4.6 Oxygen Flow and purity
After 30 minutes running the oxygen concentrator, the oxygen flow should satisfy the designed requirements 92.2% PASS
and oxygen purity should be ≥ 90%
4.7 Colors for panel display, indicator and buttons (except words or digits display)
4.7.1 If the oxygen concentrator fails down to work, the red light should illuminate with alarm constantly to remind PASS PASS
operator’s caution.
4.7.2 When the red light is illuminating continuously, it should request operator to settle a solution immediately. PASS PASS
4.7.3 When the yellow light is illuminating, it is requesting operator’s caution, or review, or an unexpected lagging PASS PASS
before running the unit.
4.7.4 Green light is ON means the oxygen concentrator is ready, or indicates the unit is running on normal stage. PASS PASS
Engineering tests
43
Laboratory tests
4.13 Environmental inspection
Rated low temperature inspection

Temperature: 5 ℃, test period: 1 hour, Power: AC198V
4.3.2.1 Oxygen purity: ≥90% (V/V) 91.6% (V/V) PASS
Low temperature storage inspection

Temperature: -20 ℃ , test period: 4 hours
Rated high temperature inspection

44
Temperature: 40 ℃, test period: 1 hour, Power: AC242V
Running inspection
Temperature: 40 ℃, test period: 4 hours, Power: AC242V
High temperature storage inspection

Temperature: 55 ℃ , test period: 4 hours
Rated damp heat inspection

Temperature: 40 ℃ , humidity: 80±3%, test period: 4 hours
Damp heat storage inspection

Temperature: 40 ℃ , humidity: 93±3%, test period: 48 hours
Vibration inspection
Frequency cycle range: 5Hz-35Hz-5Hz
Swing rate: 0.35mm
Sweep cycle frequency: 15
Sweep rate: ≤1 oct/min
45
Crash inspection
Accelerated speed: 50m/s²
Impulse duration: 11ms±2ms
Crash frequency: 1000±10
Impulse repeat frequency: 1.0Hz-1.7Hz
Impulse waveform: semi-sine wave
Transportation inspection
Transportation test facility: Simulated tertiary highways as per standard JTG B01-2003
Vehicle distance: 200km
Vehicle speed: 30km/h-40km/h
46
Below is blank
17.Medical device labeling
47
18. Risk analysis
risk control measures Risk estimation after

initial hazard
taking new measures
Se Ri Whet
Foreseeable events v Prob s Measure plan (initial) Implementation her
Hazar Hazar Hazardous e abilit k verification
and events Result or damage y to
d No d type situation ri le Severi Proba Risk
sequence ty v ty bility level
gene
el rate
new
risks
The supplier's choice of R 1. The nasal oxygen tube selects
nasal oxygen tube a material that is biocompatible;
material has not Contact with the May cause poisoning,
2. Select suppliers must have
Biologi passed the patient's body with a irritation, and other Procurement contract
relevant qualifications,
H1 cal biocompatibility test toxic or symptoms, causing 3 4 requirements and incoming 3 2 A NO
hazard and biological non- biocompatible nasal damage to patients' 3. The supplier can provide the inspection procedures.
toxicity test of the cannula material health material biocompatibility test
authoritative qualification certificate of the
organization. authoritative testing organization.
Material selection for May cause poisoning,

For parts that are in contact with Procurement contracts,
Biologi housing, power cord, Contains toxicity or irritation, and other
the human body, see the quality guarantees, etc.
H2 cal switch, humidification is incompatible with symptoms, causing 3 4 R 3 1 A NO
instruction manual and select a signed with suppliers, and
hazard bottle and lid, flow the human body damage to patients'
qualified supplier. suppliers are fully qualified
adjustment knob, etc. health
1. Each oxygen
concentrator has a
corresponding instrument
Patients do not know 1. The production line has a
May cause the number and test record,
Operati the oxygen purity special station to detect the
Oxygen purity is less patient's oxygen which can be traced.
H3 on drop during oxygen 3 4 R oxygen purity; 3 1 A NO
than 90% therapy and health 2. The oxygen purity alarm
hazard therapy and health 2. Product installed oxygen purity
effects to decline device is regularly
care indication and alarm function
compared with the oxygen
purity tester to ensure that it
is in good condition.
Pure water in the 1. Wet the bottle to choose PP

There may be
Biologi humidifier is not food raw materials; not overdue
bacteria or viruses in May cause damage
H4 cal regularly replaced; the 2 4 R use; See instructions 2 1 A NO
expired purified to the user's body
hazard effectiveness of daily
water 2 instructions to remind users to
cleaning
regularly replace the pure water in
48
the humidifier
1. The special engineer is located 1. Each oxygen

in the production line to detect the concentrator has a
May cause the oxygen purity, oxygen flow rate, corresponding instrument
Operati oxygen concentrator Oxygen flow, oxygen and test the police uniform to
patient's oxygen number and test record,
H5 on oxygen flow and purity purity does not meet 3 4 R meet the standard requirements; which can be traced. 2. The 3 2 A NO
therapy and health
hazard is too low the requirements
effects to decline 2. Product oxygen purity indicator device is regularly
indication function and flow compared with the test
display function instrument.
1. The noise of
equipment operation
exceeds that of the 1. May affect the
human body; physical and mental 1. See the parts list;
The patient may come health of patients; 1. Use noise reduction tube and
into contact with the 2. Insulation damage
sponge to reduce noise; 2. See the noise test report;
outer surface of the causes leakage 2. May cause
Energy current to exceed
H6 machine (housing, damage to the user's 2 4 R 2. Use double insulation and fuse; 3. See the leakage current 2 1 A NO
hazard
switch, etc.), and the the standard; body; test report;
casing may be hot or 3. The output 3. The product's air duct design is
3. May affect the reasonable 4. See the high temperature
damaged. temperature exceeds operation of other test report
the standard; electrical equipment
4. Exhaust port
temperature
Ambient temperature
range:
5 °C ~ 35°C relative
humidity range:
oxygen concentrator
Operati 20%~80% pressure The instructions clearly indicate
is used beyond the May affect machine
H7 on range: 2 5 R the normal working conditions of See instructions 2 1 A NO
environmental performance
hazard the oxygen concentrator
860hPa to 1060hPa requirements
Voltage: AC 230V ±
10%
Frequency: 50Hz ± 1Hz
Propagating outward 1. Consider the conducted 1. Product design

Loop current produces
Energy low frequency Conducted through the power interference when designing the documents can be found in
H8-1 line may affect the 2 4 R circuit, reduce the current loop 2 1 A NO
hazard electromagnetic interference the EMC test report;
power quality of the area during wiring, and give the
interference when the
entire power grid, interference processing method in 2. Product instruction
49
device is powered thereby interfering the technical specification; manual
with the normal
operation of other 2. Conduct electromagnetic
electrical equipment compatibility test according to the
connected in the requirements of EN60601-1-2 2.
same power grid. Prepare the product specification
for electromagnetic compatibility
environment
1. Consider radiated interference

when designing the circuit, avoid
Propagating in space interference when wiring, and give
in the form of the interference processing
High-frequency electromagnetic 1. Product design
method in the technical
electromagnetic waves, may be documents can be found in
Energy Radiation specification;
H8-2 interference occurs coupled to other 2 4 R the EMC test report; 2 1 A NO
hazard interference 2. Conduct electromagnetic
when the device is equipment, interfere 2. Product instruction
powered on with the normal compatibility test according to the
manual
operation of other requirements of EN60601-1-2 2.
electrical equipment, Prepare the product specification
environment
1. Consider suppressing harmonic

interference when designing the
When the device is circuit, and give the interference
Propagating through processing method in the 1. Product design
powered on, the non-
the wires may affect technical specification; documents can be found in
pure resistive load
Energy the normal operation the EMC test report;
H8-3 distorts the current Harmonic current 2 4 R 2. Conduct electromagnetic 2 1 A NO
hazard of other electrical
waveform and compatibility test according to the 2. Product instruction
equipment in the
generates harmonic requirements of EN60601-1-2 2. manual
entire power grid.
current Prepare the product specification
environment
1. When designing the circuit, the

compensation method is used to
May affect the normal reduce the voltage fluctuation and
operation of other the flicker interference, and the 1. Product design
The compressor starts electrical equipment processing method of the documents can be found in
Energy Voltage fluctuation the EMC test report;
H8-4 to cause voltage in the entire power 2 4 R interference is given in the 2 1 A NO
hazard flicker
fluctuations and flicker grid, causing the technical specification; 2. Product instruction
lighting of the lighting manual
fixtures to flash 2. Conduct electromagnetic
compatibility test according to the
requirements of EN60601-1-2 2.
Prepare the product specification
50
environment
1. When designing the circuit,

consider electrostatic
interference, increase the
electrical clearance during wiring,
strengthen the static immunity,
strengthen the sealing of the
Persons carrying static May affect the normal operation panel, block the 1. Product design
electricity or other operation of the electrostatic transmission path, documents can be found in
Energy objects that come into Electrostatic machine, which may and give the interference the EMC test report;
H8-5 2 4 R 2 1 A NO
hazard contact with or discharge cause the machine treatment method in the product
approach a running screen and keys to technical specification; 2. Product instruction
device malfunction. manual
2. Conduct electromagnetic
compatibility test according to the
requirements of EN60601-1-2 3.
Prepare the product specification
environment
1. Consider the radiation

interference when designing the
High-frequency circuit, strengthen the radiation
electromagnetic immunity, and give the
Electro interference emitted by May affect the normal interference treatment method in 1. Product design
magnet other nearby electrical Radio frequency operation of the the product technical documents can be found in
H8-6 ic equipment, transmitted electromagnetic field machine and affect 2 4 R specification; the EMC test report; 2 1 A NO
interfer to the space by radiation the oxygen 2. Conduct electromagnetic 2. Product instruction
ence electromagnetic waves, production compatibility test according to the manual
coupled to the running requirements of EN60601-1-2 3.
equipment Prepare the product specification
environment
51
19. Manufacturer information
Process Flowchart
Materials aging test
Materials purchase Materials Assembling of Finished product Packing Products

contract inspection products * Inspection* Storage
Un-qualified items Un-qualified items
Note: “*” as a key control points

1, Introduction of the Process Flowchart:
Note: All Materials are standardized parts which are manufactured and purchased from the factory’s upstream suppliers.
1.1 Materials purchase contract: Purchase department purchases the Materials in accordance with the production schedule, and places the purchase order to the suppli
ers. The suppliers should produce and supply the Materials to the purchaser in accordance with the order. The purchaser should fill up the product inspection list and
then provide it to the quality management department.
1.2 Materials inspection: in order to avoid the un qualified Materials be assembled to the product, the incoming materials should be tested by the Inspector in accordan
ce with the inspection requirements. Only the qualified materials are approved to storage into the warehouse, otherwise the un qualified materials should be returned
to the suppliers by purchaser.
1.2.1 Materials aging test：The main required inspected materials consist of magnetic valve, air compressor, etc. Once the first materials samples are binging in by
the purchaser, they should be processing the aging test by the quality management department. Hereafter there will come out with a test report which should be sent
52
to purchaser before the purchaser can place the bulk orders for qualified materials from the suppliers.
1.3 Assembling of products: The assembling staff should collect the materials from the Storeroom in accordance with the production schedule. The general assembling
process are as below:
1.3.1 Inject the molecular sieve into the sieve tower, solid it with the upper and lower covers. Install the magnetic valve.
1.3.2 Install the sieve tower on the noise reducer cover, and tie them
1.3.3 Install the shock absorber to the oil free air compressor and then solid it to the unit cover
1.3.4 Connect all pipes well according the air pipe diagram
1.3.5 Connect all wires well according to the wire diagram
1.3.6 Solid all the assembled panel and unit covers, then the unit is finished assembling.
Note: All the product assembling steps should follow the Work Guidance. After assembling, all products should be processing self-inspection in advance. If
there is unqualified unit, an immediate correction action is required. Only when the unit is qualified, there should come out with a test report which should be
presented to the quality management department for Finished product Inspection.
1.4 Finished product Inspection: The QC should test the product and fill up the inspection form in accordance with the finished product inspection standards. If there is
unqualified product, they should inform the assembling staff to make correction, only after the product is corrected and re-test qualified, it can be processing to the
packing staff for packing.
1.5 Packing: The packing staff should pack the products in accordance with the packing guidance. The packing staff should understand and collect the necessary
accessories in accordacne with the order's requirement and product's configuration. Only when all requirements are satisfied, they can pack the finished products.
1.6 Products Storage: The packed products should be recorded with the order number in accordance with the production schedule before they can be stored into the
warehouse. The warehouse should meent the requirements of ventilation, moistureproof, dry, etc
2. Requirements of key control points:

When inject the molecular sieve into the sieve tower, solid it with the upper and lower covers, there should no any leackage of gas situation. After assembling of this step,
the assembling staff should do self-inspection on the sieve tower.
3. Troubleshootings during assembling process

When there is a abnormal situation on product during the assembling process, the QC should issue the "Quality Abnormal Report", anaylse the causes and give
correction actions as soon as possible.
53
4. Processing Inspection:
The inspector should inspect the products every day in accordance with the " Processing Inspection Requirements". After the assembling staff finish self-inspection,
the QC should make first inspection and secondary inspection, and sign to confirm on the "Final QC Inspection Report"
The sites (including contract manufacturers) where design and manufacturing activities are listed as below:
Corporate Name ： AngelBiss Medical Technology Co., Ltd.
Corporate Address and zip ： R2, No.106, Shuanghe Road, Dianshanhu Town, 215345, Kunshan, Jiangsu, China
Corporate Phone : + 86 512-57395576 Fax : +86 21-69213653
Contact person: Avan Li
Email/ info@angelbisscare.com
54

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MEDICAL DEVICE NAME : Oxygen Concentrator

Prepared by ( Name / Signature ) : Avan Li

1. Executive Summary ……………………………………………………………………….3

Indications for use

b. Commercial marketing history:

Year Product Name countries

2018 Oxygen Concentrator Ukraine

2018 Oxygen Concentrator Hotland

2018 Oxygen Concentrator Malaysia

2018 Oxygen Concentrator India

2018 Oxygen Concentrator South Africa

2018 Oxygen Concentrator Pakistan

2019 Oxygen Concentrator Indonesia

2019 Oxygen Concentrator Bulgaria

Symbol Meanings Symbol Meanings

～ Alternating current Warning

Turn off (Main Power) Turn on (Main Power)

Date of manufacture Serial number

No open flame fire open

Keep Dry Stack Limit

No Rolling Temp Limit

Humidity Limit Atmosphere Pressure Limit

d. List of regulatory approval

No. Standard Version Name of document

Medical devices - Symbols to be used with medical device

2 EN 1041 2008 Information supplied by the manufacturer of medical devices

3 EN ISO 14971 2012 Medical devices - Application of risk management to medical

2005+ Medical electrical equipment — Part 1: General requirements for

9 EN 62366-1 2015 Medical devices - Application of usability engineering to medical

10 EN 62304 2006 Medical device software — Software life-cycle processes

2010+ Medical electrical equipment –Part 1-6: General requirements

Medical electrical equipment Part 2-69: Particular requirements

Medical electrical equipment - Part 1-8: General requirements

e. Status of pending request for market clearance

There is no any pending request for market clearance.

f. Important Safety related information

告知用户由于所提供防护措施的缺陷而带来的残留风 MD Essential Requirements

ENISO14971:2012 Risk management report

II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

7. Chemical, physical and biological properties

EN ISO14971:2012 Risk management

/ The device does not include /

For the substances referred to in the first paragraph, the

When the relevant medicines competent authority (i.e. the

If the intended use of such devices includes treatment of

8. Infection and microbial contamination

8.1 The devices and their manufacturing processes must be A

8.2 Tissues of animal origin must originate from animals that

Processing, preservation, testing and handling of tissues,

N/A / The device is not sterile /

ENISO80601-2-69:2014 Report test No.

N/A / The device is not sterile /

N/A / The device does not need /

N/A / The device does not need /

9. Construction and environmental properties

9.2 Devices must be designed and manufactured in such a

the risk of injury, in connection with their physical

risks arising where maintenance or calibration

11. Protection against radiation

General N/A / No radiation /

Intended radiation / No radiation /

Unintended radiation N/A / No unintended radiation /