| ISO 13485:2003 |
Requirements for
Quality Management System of Medical Device companies |
| ISO 11607-1:2006 |
Packaging for
terminally sterilized medical devices. Requirements for materials, sterile
barrier systems and packaging systems |
| ISO 11607-2:2006 |
Packaging for
terminally sterilized medical devices. Validation requirements for forming,
sealing and assembly processes |
| ISO 15882:2008 |
Sterilization of
health care products. Chemical indicators. Guidance for selection, use and
interpretation of results |
| ISO 17665-1:2006 |
Moist Heat/Steam
Sterilization method |
| ISO 25424:2009 |
Low temperature
steam and formaldehyde method |
| ISO 17665-1 |
Sterilization of
health care products - Moist heat - Part 1: Requirements for the
development, validation and routine control of a sterilization process for
medical devices |
| ISO 10993-7 |
Biological
evaluation of medical devices - Part 7: Ethylene oxide sterilization
residuals |
| ISO 11135-1 |
Sterilization of
health care products - Ethylene oxide - Part 1: Requirements for the
development, validation and routine control of a sterilization process for
medical devices |
| ISO 11138-1 |
Sterilization of
health care products - Biological indicators - Part 1: General requirements |
| ISO 11138-2 |
Sterilization of
health care products - Biological indicators - Part 2: Biological indicators
for ethylene oxide sterilization processes |
| ISO 11737-1 |
Sterilization of
medical devices - Microbiological methods - Part 1: Determination of a
population of microorganisms on products |
| ISO 11737-2 |
Sterilization of
medical devices - Microbiological methods - Part 2: Tests of sterility
performed in the validation of a sterilization process |
