Sterilization Info

Lisa Foster, Adiuvo Principal, is a leader in the sterilization industry and leads the AAMI and ISO working groups to develop the sterilization standards for the industry. In her 25 years, she has seen it all when it comes to sterilization.

Her extensive experience in developing sterilization processes, validations, quality system requirements and knowledge of standards relating to sterilization has helped numerous manufacturers throughout her tenure. She will focus on defining the root cause, identifying corrective action, and assist you in developing the plan to implement the corrective action all the way to your sterilization provider.

Ms. Lisa Foster holds a Bachelor of Science in Food and Nutrition from Mississippi University for Women and a Masters of Science in Food Technology from Mississippi State University.

Contact Us to learn how we can assist you!

Lisa Foster  |  Principal  |  Adiuvo QS & SA Consulting  |  Anaheim, CA 92807
Email: Lisafoster@adiuvo-qs-sa-consulting.com
Office: 949-429-1868 • Mobile: 714-815-2828

AAMI/ISO Standards Related to Sterilization of Healthcare Products: www.aami.org

  Title
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 TIR32:2004 Medical device software risk management
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 11135-1:2007 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