AAMI TIR37:2007
Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products

Standard No.
AAMI TIR37:2007
Release Date
2007
Published By
Association for the Advancement of Medical Instrumentation  US  /  AAMI
Status
Replace By
AAMI TIR37:2013
Latest
AAMI TIR37:2013
 
Scope
This Technical Information Report provides guidance on special considerations for sampling and testing techniques that are used in the validation of radiation sterilization of human tissue-based products.

AAMI TIR37:2007 history

  • 2013 AAMI TIR37:2013 Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
  • 2007 AAMI TIR37:2007 Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products

Topics on standards and specifications

Sterilization Lot Sampling + Product Sterilizing radiation of healthcare products

Standard and Specification

DIN EN ISO 11137-3 E:2015-08 Sterilizing radiation for health care products Part 3: Guidance on development, validation and routine control of doses (draft AAMI/ISO 11137-3:2006(R2010 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects AAMI/ISO 11137-3:2017(R2023 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine DIN EN ISO 11137-2 E:2012-10 Sterilizing radiation for health care products Part 2: Determination of germicidal dose (draft AAMI TIR37:2013 Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products BS EN ISO 11137-3:2017 Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control AAMI TIR37-2013 Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based products GSO ISO/TS 22456:2023 Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue AAMI/ISO TIR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch


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