On August 6, CFDA published 17 industry standards, covering sterilization of infusion device, biological testing, and standardization of medical consumables.
1. Test methods for packaging of sterilized medical devices: Breathable packaging material aerosol filtration method microbial barrier test
2. Test methods for packaging of sterilized medical devices: Non-destructive testing of packaging leaks by vacuum attenuation method
3. Intravascular catheters – Disposable sterile catheters: Subcutaneous implantable devices
4. Special requirements for safety of blood, intravenous liquid and lavage warmer
5. Determination of 2-chloroethanol residues in disposable PVC infusion devices
6. Large-aperture connectors for medical fluids and gases: connector for gastrointestinal use
7. Small aperture connectors for medical liquids and gases: axle connector
8. Special infusion sets: Infusion sets for single use
9. Special infusion sets: Scale flow adjustment
10. Determination of strength and curing time of synthetic water-activated polyurethane glass fiber orthopedic bandages
11. Standard Test Model for Evaluation of Performance of Contact Wound Dressings: In vitro model for evaluation of hemostatic properties
12. Disposable medical gloves: resistance to chemical penetration
13. Medical device complement activation test: determination of complement activation products (C3a and SC5b-9)
14. Evaluation for immunogenicity of medical device: determination of spleen lymphocyte subsets in animals by flow cytometry
15. Medical Device Biological Evaluation: medical device neurotoxicity test selection guide
16. Medical device genotoxicity test: In vitro mammalian cell micronucleus test
17. Medical device and platelet interaction test: In vitro platelet activation test
For complete versions of industry standard mentioned above, please email info@ChinaMedDevice.com.
For 2018 Standardization Revision Plan, please email us too.
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