Biological evaluation standards: ISO10993
Guidance management standards
Production control standards for special categories of products: EN 12442-2000 Animal Tissues and their Derivatives for the Production of Medical Devices Part I: Risk Analysis and management.
Standards for the control and inspection of microorganisms on medical devices:ISO 11737,YY0466
Standards for confirmation and routine control of sterilization of medical devices:GB18278,ISO14937
Standards for packaging of final sterilized medical devices:GB19633
Standards for clean areas and their control of medical devices: ISO14644
Standard for the control of viruses in medical devices of animal origin: EN12442
Standard for the confirmation and routine control of aseptic processing techniques for medical devices: ISO13408
Standard for clinical investigations of medical devices: YY0279
Standard for test methods: GB14233
Related terms The standard of the test method: GB/T19971