AAMI/ISO standards detail the requirements and guidance used throughout the industry. These standards are consensus voluntary standards which are the minimum requirements for the manufacturing and sterilization of Medical Products. With a combination of these standards and the years of experience, Sterilization Consulting Services can provide solutions for all of sterilization needs.
| AAMI TIR14:2009 | Contract sterilization using ethylene oxide |
| AAMI TIR15:2009 | Physical aspects of ethylene oxide sterilization |
| AAMI TIR16:2000 | Process development and performance qualification for ethylene oxide sterilization – Microbiological aspects |
| AAMI TIR17:2008 | Compatibility of materials subject to sterilization |
| AAMI TIR19/A1:1999 | Amendment 1 to AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals |
| AAMI TIR20:2001 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices- Part 1 and Part 2: 2006 |
| AAMI TIR22:2007 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006 (Now includes the 2008 amendment.) |
| AAMI TIR22:2007/A1:2008 | Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006, Amendment 1 |
| AAMI TIR28:2009 | Product adoption and process equivalence for ethylene oxide sterilization |
| AAMI TIR29:2002 | Guide for process control in radiation sterilization |
| AAMI TIR31:2008 | Process challenge devices/test packs for use in health care facilities |
| AAMI TIR33:2005 | Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose – Method VDmax |
| AAMI TIR37:2007 | Sterilization of health care products — Radiation — Guidance on sterilization of human tissue-based products |
| AAMI TIR40:2009 | Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2 |
| ANSI/AAMI ST67:2003/(R)2008 | Sterilization of health care products – Requirements for products labeled “STERILE” |
| ANSI/AAMI/ISO 10993-1:2003 | Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing |
| ANSI/AAMI/ISO 10993-12:2002 | Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials |
| ANSI/AAMI/ISO 10993-17-2002 | Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances |
| ANSI/AAMI/ISO 11135-1:2014 | Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-1:2006 (R2010) | 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 11137-2:2006 | Sterilization of health care products-Radiation – Part 2: Establishing the sterilization dose |
| ANSI/AAMI/ISO 11137-3:2006 (R2010) | Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects |
| ANSI/AAMI/ISO 11138-1:2006 (R2010) | Sterilization of health care products – Biological indicators – Part 1: General requirements |
| ANSI/AAMI/ISO 11138-2:2006 (R2010) | Sterilization of health care products -Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes |
| ANSI/AAMI/ISO 11138-3:2006 (R2010) | Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes |
| ANSI/AAMI/ISO 11607-1:2006/ (R2010) | Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems |
| ANSI/AAMI/ISO 11607-2:2006/ (R2010) | Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes |