Disposable Infusion Pump

Biological Evaluation

Henan Tuoren Medical Device Co., Ltd.

Signature: 【姓名（手签）】
Position: Manager of Quality Control
1、Product description

1.1 Product name: Disposable Infusion Pump

1.2 Operation Principle: Connect the disposable infusion pump to anesthesia catheter,
I.V. Cannual, central venous catheter, anesthesia needle and infusion needle. Infusion
pump depend on reservoir’s contraction force and use micro-flow control tube to
control flow rate, then the drug could keep injecting. The drug liquid filter is installed
at the flow outlet to control the entry of particles into human body.
1.3 Intended use: Clinically used for postoperative infusion of analgesic drugs or
antibiotic drugs.
1.4 Type:
Normal type: CBI、CBI+PCA Avoid light type: CBI、CBI+PCA

Nominal Volume Nominal flow rate Nominal bolus Nominal bolus refill time
volume

0.5/0.8/1/1.5/2/2
.5/3/4/5/6/7/8/10
50/60/70/100/120/
/11/12/13/14/15/
130/150/200/240 0.5/1/2ml 5/6/8/10/15/30/60min
18/20/25/40/50/
275/300ml
70/80/100/120/1
30/200/240ml/h

1.5 Product classification: According to medical device classification, infusion pump

is blood and liquid infusion apparatus and tubes in medical polymer products,
belonging to class III medical device of long-term indirectly connecting with blood
vessels, and together with other products (such as I.V. Cannula) to human body.

1.6 Components: It is mainly composed of protective bottle (avoid light type’s

color is brown), silicone hoop, One-way valve drug-adding device, reservoir,
drug liquid filter, flow limiting device, PCA device (available not have),
pipeline, drug outlet. All the components and processing materials are meet
the requirements of medical materials.

Structure; image 1, image 2

 1-protactive bottle 2-silicone hoop 3-reservoir 4-injection tubing 5-One-way valve drug-adding
device 6- Clamp 7-Filter 8-PCA device 9 transparent small tee 10 lower-infusion tubing 11-Drug
outlet

Image 1 Type I: CBI+PCA

1-Hard case bottle 2-silicone hoop 3-reservoir 4-injection tubing 5-One-way valve drug-adding
device 6- Clamp 7-Filter 8-flow limit device 9-Drug outlet

Image 2 Type I CBI+PCA

1.7 Raw material: the product is mainly made of transparent ABS （MABS）,
ABS, SAN, medical silicone and polypropylene.

2、Biology Assessment

2.1 Assessment Standard: ISO10993-1 and product classification

2.2 Assessment Purpose: According to ISO10993-1 and combined with the products’
characteristics, conduct a test for the product’s biological parameters to support the
clinical use.

2.3 Assessment Methods: Being classified as class III medical devices, infusion pump
contacts to blood indirectly, which should be meet the biology assessment of
ISO10993-1 and the corresponding requirements in biological detection.

See detail in chart 1.

Chart 1
Details of ISO10993-1 Apply to Apply or not Products Attributes
2.Requirements for ×
Animal Welfare
3. genetic toxicity test, This medical device is ×
carcinogenicity test, deemed to have potential
reproductive toxicity test. genetic toxicity,
carcinogenicity, or
reproductive toxicity
4.the test of interact with Medical device contact √ √（Hemolytic ）
blood with blood and dental
device.
5. In vitro cytotoxicity In vitro cytotoxicity test √ √（cytotoxicity ）
test is general, which can be
applied to any assessment
of medical device and
materials.
6. Local reactions test Biological safety ×
after implantation assessments of test
material which implanted
into some certain parts of
living body.

7.Ethylene oxide Ethylene oxide sterilized √ √

sterilization residues medical device

8. Not Tested
9. Framework for The biology ×
identification and degradative medical
quantification of potential device which is potential
degradation products and the device which has
been observed.
10 Tests for irritation and The chemical substances √ √ （ Including the
skin sensitization released by medical intradermal irritation and
device may cause the skin sensitization ）
flowing contact harm.
Including skin irritation,
poke stimulation, eye
irritation and skin
sensitization.
11. Tests for systemic √ √（Acute toxicity ）
toxicity
12. Sample preparation ×
and reference materials
13 Identification and ×
quantification of
degradation products from
polymeric medical
devices
14 Identification and Ceramic materials ×
quantification of （including glass ）
degradation products from
ceramics
15. Identification and The finished metal ×
quantification of device
degradation products from
metals and alloys
16. Toxicokinetic study Should consider the ×
design for degradation necessity of toxicokinetic
products and leachables study design according to
the contact nature and
practice between human
body and medical device.
17. Establishment of Not apply to the medical ×
allowable limits for device which not contact
leachable substances to human beings.
18 Chemical ×
characterization of
materials.
19. The characterization ×
of material physical
chemical and
morphology

3 Summary

According to ISO10993 applying to biological evaluation of this product, the

test of interact with blood, in vitro cytotoxicity test, ethylene oxide sterilization
residues, tests for irritation and skin sensitization and tests for systemic toxicity are
applied for this product, other biological evaluations aren’t applied for this product.
So the test of interact with blood, in vitro cytotoxicity test, ethylene oxide sterilization
residues, tests for irritation and skin sensitization and tests for systemic toxicity all
comply with the biological requirements of ISO10993-1, so the biological evaluation
of this product is qualified and effective.