Standards
AAMI/ISO standards detail the requirements and guidance used throughout the medical device, tissue bank and pharmaceutical industries. These standards are the minimum requirements for the manufacturing and sterilization of medical device, tissue bank and pharmaceutical products. QVEX Consulting can help you with all of your sterilization and validation needs.
Applicable Standards (not an exhaustive list)
| AAMI TIR17 | Compatibility of materials subject to sterilization |
| AAMI TIR20 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices- Part 1 and Part 2 |
| AAMI TIR22 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2 (Now includes the 2008 amendment.) |
| AAMI TIR22/A1 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2, Amendment 1 |
| AAMI TIR29 | Guide for process control in radiation sterilization |
| AAMI TIR31 | Process challenge devices/test packs for use in health care facilities |
| AAMI TIR33 | Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose – Method VDmax |
| AAMI TIR37 | Sterilization of health care products — Radiation — Guidance on sterilization of human tissue-based products |
| AAMI TIR40 | Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2 |
| ANSI/AAMI ST67 | Sterilization of health care products – Requirements for products labeled “STERILE” |
| ANSI/AAMI/ISO 11137-1 | Sterilization of health care products – Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-2 | Sterilization of health care products-Radiation – Part 2: Establishing the sterilization dose |
| ANSI/AAMI/ISO 11137-3 | Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects |
| ANSI/AAMI/ISO 11138-1 | Sterilization of health care products – Biological indicators – Part 1: General requirements |
| ANSI/AAMI/ISO 11138-3 | Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11607-1 |
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems |
| ANSI/AAMI/ISO 11607-2 |
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes |
| ISO 14644-1/ ISO 14644-2/ ISO 14644-3/ ISO 14644-4 |
Cleanrooms and Controlled Environments Standards |
| USP <61> and <62> |
Microbiological Examination of Nonsterile Products |
| USP <71> |
Sterility Testing |
| USP <1227> |
Validation of Microbial Recovery from Pharmacopeial Articles |
| AAMI/ISO 11737-1 |
Sterilization of Medical Devices – Microbiological Methods – Part 1: Determination of the population of microorganisms on product. |