Bioburden in primary packaging of sterile medical devices
Bioburden in primary packaging of sterile medical devices, Total:22 items.
The international standard classification for "Bioburden in primary packaging of sterile medical devices" includes: Sterilization and disinfection in general , Sterilization and disinfection .
The Chinese standard classification for "Bioburden in primary packaging of sterile medical devices" includes: Public medical equipment , Medical apparatus and devices in general .
Group Standards of the People's Republic of China
- T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
- T/CAMDI 009.3-2023 Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms
- T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
- T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices
- T/SHBX 005-2023 Sterilizable packaging films for medical devices
- T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
- T/CAMDI 009.10-2024 Cleanliness of primary package for sterile medical device Part 10：Limits of contamination
Professional Standard - Nuclear Industry
- EJ/T 1243-2017 Radiation sterilization of Medical Devices--Analysis method on Bioburden Data for the Purpose of Validation for Sterilization Dose
国家药监局
- YY/T 1737-2020 Analytical method for bioburden control level of medical device
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
- GB/T 19633-2005 Packaging for terminally sterilized medical devices
German Institute for Standardization
- DIN 58953-6:2023-04 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
- DIN 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
- DIN 58953-6:2023-11 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN
- DIN 58953-6:2023 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Korean Agency for Technology and Standards (KATS)
- KS P ISO 11607-2007 Packaging for terminally sterilized medical devices
SCC
- AAMI 11607:1997 Packaging for terminally sterilized medical devices
- AAMI/ISO 11607:2000 Packaging for terminally sterilized medical devices
- DIN 58953-6 E:2016 Draft Document - Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
American Society for Testing and Materials (ASTM)
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
British Standards Institution (BSI)
- BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
