Examples of Particular

Standars Related to
Specific Products

DECEMBER 21

Name : 鄭德明
ID : 1074407012

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1. IEC 60601-2-2. High Frequency Surgical Equipment Ed. 3 (09/98)
Ed. 4 (Project). [AAMI HF 18-331].

HF surgical equipment having a rated output

power not exceeding 50 W (for example for
micro-coagulation, or for use in dentistry or
ophthalmology) is exempt from certain of the
requirements of this particular standard. These
exemptions are indicated in the relevant
requirements.
The object of this particular standard is to
establish particular basic safety and essential
performance requirements for HF surgical
equipment and HF surgical accessories.
This edition includes the following
significant technical changes with respect to the
previous edition:
- refinement and additions to the defined terms;
- additional separation of the requirements for
HF surgical equipment and HF surgical
accessories;
- a new requirement for adult neutral electrodes
to be contact quality monitoring neutral
electrodes;
- new requirements for devices that have or use a
high current mode.

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2. IEC 60601-2-3. Short-Wave Therapy Equipment Ed. 2
(06/91), Am.1 (09/98) Ed.2 (Project).

IEC 60601-2-3:2012 specifies the

requirements for the basic safety
and essential performance of short-
wave therapy equipment. Short-
wave therapy equipment are
defined as medical equipment for
the therapeutic treatment of a
patient by exposure to electric or
magnetic fields produced in the
frequency range of more than 13
MHz but not exceeding 45 MHz.
Equipment having a rated output
power not exceeding 10 W are
exempted from certain
requirements of this standard. This
edition constitutes a technical
revision and has been aligned with
IEC 60601-1:2005

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3. IEC 60601-2-4. Cardiac Defibrillators And Cardiac
Defibrillator-Monitors (01/83), Ed. 2 (08/020).

IEC 60601-2-4:2010 establishes particular basic safety and

essential performance requirements for cardiac defibrillators.
This edition constitutes a technical revision, revised to
structurally align it with IEC 60601-1:2005 and to implement the
decision of IEC SC 62A that the clause numbering structure of
particular standards written to IEC 60601-1:2005 would adhere to
the form specified in ISO/IEC Directives, Part 2:2004. The aim
of this third edition is to bring this particular standard up to date
with reference to the third edition of the general standard through
reformatting and technical changes.

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4. IEC 60601-2-5. Ultrasonic Therapy Equipment (01/84), Ed.
2 (07/00)

This Particular Standard

specifies requirements and
tests for the safety of
ultrasonic physiotherapy
equipment. It amends and
supplements IEC 60601-1
(second edition, 1988)
including Amendments 1 and
2, hereinafter referred to as
the General Standard. This
Particular Standard takes
into account IEC 60601-1-2
and IEC 61689.

5. IEC 60601-2-6. Microwave Therapy Equipment (01/84).

IEC 60601-2-6:2012+A1:2016 specifies the minimum
requirements considered to provide for a practical
degree of safety in the operation of microwave therapy
equipment. This edition constitutes a technical revision
and has been aligned to the third edition of IEC 60601-
1:2005+A1:2012. This consolidated version consists of
the second edition (2012) and its amendment 1 (2016).
Therefore, no need to order amendment in addition to
this publication.

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6. IEC 60601-2-10: Nerve And Muscle Stimulators (12/87),
Am. 1 (09/01), Corrigendum (02/02).

IEC 60601-2-10: 2012 establishes requirements for the safety and

important performance of nerve and muscle stimulators, for use in
physical medicine practice. These include transcutaneous electrical
nerve stimulators (TENS) and electric muscle stimulators (EMS). This
second edition cancels and replaces the first edition, published in 1987
and Amendment 1 (2001). This edition is a technical revision and
harmonized with IEC 60601-1: 2005 + A1: 2012.

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 7. IEC 60601-2-19. Baby Incubators (12/90), Am. 1 (10/96).

IEC 60601-2-19: 2009 establishes safety requirements for infant incubators.

This special standard changes and complements IEC 60601-1: 2005, Medical
electrical equipment - Part 1: General requirements for basic safety and
important performance. This second edition cancels and replaces the first
edition published in 1990 and Amendment 1 (1996). This edition is a
technical revision. It was revised to align structurally with the third edition
(2005) of IEC 60601-1

8. IEC 60601-2-20. Transport Incubators (12/90), Am. 1

(10/96). IEC 60601-2-20:2009+A1:2016 specifies safety requirements for
infanttransport incubators. This particular standard amends and
supplements IEC 60601-1:2005, Medical electrical equipment -
Part 1: General requirements for basic safety and essential
performance. This second edition cancels and replaces the first
edition of IEC 60601-2-20 published in 1990 and its Amendment 1
(1996). This edition constitutes a technical revision. This edition of
IEC 60601-2-20 was revised to structurally align with the 2005
edition of IEC 60601-1. The contents of the corrigenda of February
2012 and February 2013 have been included in this copy. This
consolidated version consists of the second edition (2009) and its
amendment 1 (2016). Therefore, no need to order amendment in
addition to this publication.

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9. IEC 60601-2-21. Infant Radiant Warmers (02/94), Am. 1
(10/96).

IEC 60601-2-21:2009 specifies the safety requirements for

infant radiant warmers. This particular standard amends
and supplements IEC 60601-1:2005, Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance. This second edition cancels and
replaces the first edition published in 1994 and its
Amendment 1 (1996). This edition constitutes a technical
revision. This edition of IEC 60601 2-21 was revised to
structurally align with the 2005 edition of IEC 60601-1.

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10. IEC 60601-2-22. Diagnostic And Therapeutic Laser
Equipment Ed. 2 (11/95), Ed. 3 (Project).

IEC 60601-2-22: 2019 is available as IEC 60601-2-22: 2019 RLV

which contains International Standards and its Redline version, which
shows all changes in technical content compared to previous editions.

IEC 60601-2-22: 2019 applies to the Basic Safety and Essential

Performance of laser equipment for surgical, therapeutic, medical
diagnostic, cosmetic or veterinary applications, intended for use in
humans or animals, classified as Class 1C Laser Products where Closed
Lasers are Class 3B or 4, or Class 3B, or Class 4. Medical Electrical
Equipment or Medical Electrical Systems that combine lasers as a
source of energy that is transferred to Patients or animals and where the
laser is determined as above, referred to as "Laser Equipment" in this
document. Laser products for this application are classified as Class 1,
Class 1M, Class 2, Class 2M or Class 3R Laser Products, covered by
IEC 60825-1: 2014 and by general standards.

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11. IEC 60601-2-23. Transcutaneous Partial Pressure
Monitoring Equipment (09/93), Including Essential
Performance Ed. 2 (12/99).

IEC 60601-2-23:2011 applies to the basic safety and essential

performance of transcutaneous partial pressure monitoring
equipment. It applies to transcutaneous monitors used with
adults, children and neonates, and it includes the use of these
devices in foetal monitoring during birth. IEC 60601-2-23:2011
does not apply to haemoglobin saturation oximeters or to
devices applied to surfaces of the body other than the skin (for
example conjunctiva, mucosa). This third edition cancels and
replaces the second edition published in 1999 and constitutes a
technical revision. This edition of IEC 60601-2-23 was revised
to align structurally with the 2005 edition of IEC 60601-1.

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12. IEC 60601-2-38. Electrically Operated Hospital Beds
(10/96), Am. 1 (12/99), (Next Ed. Will Be IEC 60601-2-
52).

Specifies requirements for safety of electrically operated hospital

beds. The object of this standard is to keep the safety hazards to
patients, operators and the environment as low as possible, and to
describe tests to verify that these requirements are attained.

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