Biocompatibility Testing For FDA
About HTW Laboratory:
We offer professional biocompatibility testing at a lower cost than other labs. Our customized testing solutions can enhance process efficiency and reduce testing cycles. For technical regulation support, technicians at HTW are able to help you understand technical regulations and product design specifications. Communicate with our experts to determine your needs and we will provide you with a free evaluation, proposal and quotation.
Our Services at a Glance：
ISO 10993-1: 2018 (E) .pdf
We evaluate the biocompatibility of your medical devices in line with ISO 10993. Risk based selection of required tests, preparation of a final report. We provide the following biological risk assessment tests:
Cytotoxicity test- ISO 10993-5
Skin, intradermal and oral mucosal irritation test- ISO 10993-10
Sensitisation test- ISO 10993-10
Bioburden test- ISO 11737 series
Systemic effects of systemic toxicity and pyrogenicity - ISO 10993-11 and ASTM:
Evaluation and testing within a risk management process-ISO10993-1
Material characteristic analysis-ISO10993-18
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For more information on other types of biocompatibility testing, please contact us.
Email us if you have any questions or would like to consult an expert in our laboratory.
What is Biocompatibility Testing For Medical Devices?
An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. it studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients.
The goal for all medical device manufacturers is to provide maximised benefits to patients while minimising levels of biological risks. This requires them to comply with stringent biocompatibility testing requirements set by international regulatory bodies to ensure that their devices are medically safe to use before being made available in the market.
Which Products Require Biocompatibility Testing?
Medical equipment products that have direct contact with the human body (dedicated for surgery and other medical products that indirectly contact the human body) such as scalpels, gauze, masks, protective clothing, dental instruments, etc.
Why Choose Us?
HTW Lab, accredited by CNAS, CMA, CNCA & A2LA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of Good Laboratory Practice (GLP) and provides product testing service in accordance with national and global standards for both active and non-active medical devices. We are also IECEE CB Scheme Test Laboratory (CBTL). Thus, testing reports from HTW Lab can be accepted between countries.
Your Benefits at a Glance:
1.20 Years of experience
HTW has extensive experience in all types of devices and regulatory requirements across markets.
2.Provide free modification service
Together with our wealth of knowledge in complex regulations globally, HTW provides a complete suite of testing solutions according to your needs including free modification service.
3.Save time to global markets
With over 7,000 square meters of labs, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW can optimize your costs and minimize your time to market.
4.Complete qualifications
ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.
5.Competitve price
Testing costs are lower than other labs.
Email:
You can also contact us directly by email.
HTW Testing and Certification Solutions.
Non-active | Biocompatibility
Number | Project | Standard |
1. | Evaluation and testing within a risk management process | ISO10993-1 , G B16886.1 |
2. | Ethylene oxide sterilization residuals （ETO,ECH,EO） | ISO10993-7 , G B16886.7 |
3. | In vitro cytotoxicity test | ISO10993-5 , G B16886.5 |
4. | Sensitization test | ISO10993-10 , GB16886.10 |
5. | Skin, intradermal and oral mucosal irritation test | ISO10993-10 , GB16886.10 |
6. | Irritation test | ISO10993-23 |
7. | Acute systemic toxicity test | ISO10993-11 , GB16886.11 |
8. | Subacute systemic toxicity test | ISO10993-11 , GB16886.11 |
9. | Subchronic systemic toxicity test | ISO10993-11 , GB16886.11 |
10. | Chronic systemic toxicity test | ISO10993-11 , GB16886.11 |
11. | Material-mediated Pyrogens Test | ISO10993-11 , GB16886.11 |
12. | In vitro Mammalian Chromosome Aberration Test | ISO10993-3 , GB16886.3，ISO10993-33 |
13. | Micronuclear test | ISO10993-3 , GB16886.3，ISO10993-33 |
14. | In Vitro Mammalian Cell Gene Mutation Test | ISO10993-3 , GB16886.3，ISO10993-33 |
15. | Ames test | ISO10993-3 , GB16886.3，ISO10993-33 |
16. | Thrombogenesis test | ISO10993-4 , GB16886.4 |
17. | Coagulation test | ISO10993-4 , GB16886.4 |
18. | Platelet adhesion test | ISO10993-4，GB16886.4 |
19. | Complement activation test | ISO10993-4，GB16886.4 |
20. | Hemolysis test | ISO10993-4，GB16886.4 |
21. | Muscle implantation test | ISO10993-6，GB16886.6 |
22. | Subcutaneous implantation test | ISO10993-6，GB16886.6 |
23. | Bone implant test | ISO10993-6，GB16886.6 |
24. | Material characteristic analysis | ISO10993-18 |
… | … |
The samples should be provided safely with standard shipping status. Please provide the samples with sterile barrier packaging if the product is planned to sell under sterile conditions. Have a question about product testing and certification?
Email us at sales@htwlab.com.
1. Provide us with product pictures, product brochures/manuals
2. Determine your needs（test report purpose/ test itmes/ standards）
3. Receive the testing/compliance service proposal and quotation
4. Sign contract and make payment
5.Send samples (please contact us for address info.)
6.Informed project opening and test TAT(turn around time) via email
7.Testing
8.Draft report for your confirmation
9. Formal reports endorsed by ILAC - CNAS (electronic version)
10.Sample Discard or Return
（Below is our Biocompatibility Testing Fee Quote Template）
Class I, II, and III Medical Devices Testing and Certification
Patient Monitoring Devices Testing
Wireless Medical Device Testing
Cardiovascular Device Testing
Chemical Analysis for Medical Device Components
Medical Device Packaging Validation
Physical Testing of Medical Devices and IVD Equipment
Electrical Safety Testing (IEC 60601-1)
EMC Testing for Medical Devices
Functional Safety Testing of Medical Devices
Wireless Testing for Medical Devices
In Vitro Diagnostic Medical Devices Testing
Contact us to learn more about our orthopedic implant testing, cardiovascular device testing, biocompatibility testing, medical device packaging validation, radio frequency testing, EMI & EMC testing and others.
Biocompatibility Testing for Dental Materials
Mechanical Testing of Materials in Devices and Packaging
Chemical Analysis for Medical Device Components
Packaging Materials and Packages testing
Medical Device Materials Testing
Consulting Service
Preliminary Product Development Regulatory Guidance
Product Technical Requirements Review Service
Clinical Evaluation
Plant Construction Consulting
Quality Management System Construction
Domestic Registration/Global Market Access
China NMPA (CFDA)
US FDA (Listing, 510k)
EU CE
Brazil ANVISA (INMETRO, ANATEL )
Australian TGA
Canadian CMACAS
UK UKCA
Ensure Patient Safety With Biocompatibility Testing:
In the medical field, practitioners utilise a range of devices to address patient health, from diagnosis to surgery. When the patient comes into contact with a medical device or material, it should fulfil its intended function without inflicting any harm to the patient. Therefore, all medical devices need to undergo a thorough biological risk assessment to protect the patient from any toxic, physiological, immunogenic or mutagenic effects from the device. This can be achieved with biocompatibility testing.
Testing We Support： 1. In Vitro Cytotoxicity Test / ISO 10993-5 2. Sensitization Test / ISO 10993-10 3. Skin and Intradermal Irritation Test / ISO 10993-10 4. Bioburden Test / ISO 11737 series 5. Evaluation and testing within a risk management process / ISO 10993-1 6. Muscle implantation test / ISO 10993-6 7.Subacute Systemic Toxicity Test / ISO 10993-11 8.Contact us for additional biocompatibility testing | Product We Test: 1. Active Products: Diagnostic equipment, Treatment Equipment 2. Non-active Products: Surface Contact Apparatus, External Access Device, Personal Protective Equipment, Implanted Devices ...... |
We provide the above biological risk assessment tests to help manufacturers meet biocompatibility testing requirements of the International Organisation for Standardisation (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM).