Biological Evaluation of Medical Devices / Biosafety: Applicable Products

9/30/21, 1:22 PM Biocompatibility- HTW Lab | Speed up time to market
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Introduce
Biocompatibility  Classification
Standard
Other
Applicable Products
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Biological Evaluation of Medical Devices / Biosafety
Active products
1. Diagnostic Equipment
Physical
diagnostic kits
Thermometer,
blood pressure, microscope, audiometer, various
physiological recorder, etc.
Medical image
X-ray, CT
scan, MRI, B-scan
ultrasonography
Analytical instruments
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all types of
counter, biochemical, immune analysis instrument, etc.
electrophysiology
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electrocardiogram,
electroencephalograph, electromyograph,
etc.
Introduce
2. Treatment Equipment Standard
Other
Common
surgical instruments
Optical
fiber
endoscope, laser therapeutic apparatus, etc.
Auxiliary
anesthesia
machines, respirator, extracorporeal circulation, etc.
Radiotherapy
machinery
deep X-ray
therapeutic apparatus, cobalt-60 therapeutic apparatus,
accelerator, gamma
knife, isotope therapeutic apparatus, etc.
Others
Microwave,
hyperbaric oxygen, etc.
Non-Active
products
1. Surface Contact Apparatus
Electrodes, external prosthetics, straps,

compression bandages and
monitors;
Contact lenses, catheters, intravaginal or

gastrointestinal instruments;
Nursing apparatus and sealing applicator;
2. External Access Device Apply
Introduce
Blood transfusion, infusion set,
extender, transfer device, etc;
Endoscope, drainage system, dental

filling materials, etc; Standard
Intravascular catheters, temporary

pacing electrodes, dialyzers, dialysis
Other
tubes and accessories, vascular

adsorbents, immune adsorbents, etc.
3. Personal Protective Equipment
Medical masks, medical protective

clothing, medical gloves, medical
goggles, melt-blown cloth, etc
4. Implanted Devices
Orthopaedic nails, artificial joints,

bone prostheses, bone cement and
intraosseous devices, pacemakers,

implantable drug delivery devices,
neuromuscular sensors and stimulators,

artificial tendons, breast implants,
artificial larynx, subperiosteal

implants, ligation clips, etc
Introduction
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Free consulting service, please click "Contact Us" or send email to sales@htwtest.com
Typically, biological evaluation services are performed in accordance to ISO 10993 Biological evaluation of
medical
devices. HTW was accredited by CNAS, CMA, and meets the requirements of GLP.
We can supply
test service in accordance with national and global standards for
both active and non-active medical
products. Our familiarity with these
standards makes for a seamless and trustworthy testing process.
GLP ( Good Laboratory Practice) is an international standard to guarantee

the quality, consistency and
reliability of data generated and accumulated
through laboratory studies.
Testing:
Apply
In vitro cytotoxicity test Salmonella typhimurium Variable test

Introduce
Sensitization
test Genetic mutation test Skin and intradermal irritation test
Intradermal stimulation test Standard
Acute oral stimulation test
Thrombosis test Eye stimulation test Coagulation test Other
Vaginal stimulation
experiment、
penis, rectal,
Subacute systemic
toxicity test Platelet adhesion test
Subchronic systemic toxicity test 、

Complement activation test Cytotoxicity test
acute
Muscle implantation test Hemolysis test Heat source test
Chromosome aberration test Bone implant test Bone marrow micronucleus test
Material characteristics analysis Subcutaneous implantation test
Standards
Non-active |
Biocompatibility:
Number Project Standard

1 In
vitro cytotoxicity test ISO10993-5 , G B16886.5
2 Sensitization
test ISO10993-10 , GB16886.10
Skin, intradermal
and oral
3 ISO10993-10 , GB16886.10
mucosal irritation test
4 Stimulation
test ISO10993-23
5 Acute
systemic toxicity test ISO10993-11 , GB16886.11
6 Subacute
7 Subchronic
8 Chronic
9 Heat
source test ISO10993-11 , GB16886.11
10 Chromosome
aberration test ISO10993-3 , GB16886.3
11 Micronuclear
test ISO10993-3 , GB16886.3
12 Genetic
mutation test ISO10993-3 , GB16886.3
13 Ames
test ISO10993-3 , GB16886.3
14 Thrombogenesis test ISO10993-4 , GB16886.4
15 Coagulation
test ISO10993-4 , GB16886.4
16 Platelet
adhesion test ISO10993-4，GB16886.4
17 Complement
activation test ISO10993-4，GB16886.4
18 Hemolysis
test ISO10993-4，GB16886.4
19 Muscle
implantation test ISO10993-6，GB16886.6
20 Subcutaneous
implantation test ISO10993-6，GB16886.6
21 Bone
implant test ISO10993-6，GB16886.6 Apply
22 Material
characteristic analysis ISO10993-18
… … … Introduce
Standard
Other
Others
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Monday - Friday
8.30am - 5.00pm in CST (UTC/GMT+08:00)
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9/30/21, 1:22 PM Biocompatibility- HTW Lab | Speed up time to market

We're here for you.

Biological Evaluation of Medical Devices / Biosafety

physiological recorder, etc.

2. Treatment Equipment Standard

1. Surface Contact Apparatus

Electrodes, external prosthetics, straps,

Contact lenses, catheters, intravaginal or

Nursing apparatus and sealing applicator;

2. External Access Device Apply

Endoscope, drainage system, dental

Intravascular catheters, temporary

tubes and accessories, vascular

3. Personal Protective Equipment

Medical masks, medical protective

goggles, melt-blown cloth, etc

Orthopaedic nails, artificial joints,

intraosseous devices, pacemakers,

neuromuscular sensors and stimulators,

artificial larynx, subperiosteal

GLP ( Good Laboratory Practice) is an international standard to guarantee

In vitro cytotoxicity test Salmonella typhimurium Variable test

Subchronic systemic toxicity test 、

Number Project Standard

Our Business Hours:

8.30am - 5.00pm in CST (UTC/GMT+08:00)

Last article：EMC Testing

Copyright 2021 Shenzhen Huatongwei International Inspection Co., Ltd.

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