AAMI ISO TIR 13004 :2013

Name: AAMI ISO TIR 13004 :2013
Brand: AAMI

Superseded

View Superseded by

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD]

Available format(s)

Hardcopy , PDF

Superseded date

01-09-2021

Language(s)

English

Published date

01-01-2016

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TS 13004:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for
  sterilization dose substantiation and sterilization
  dose auditing
5 Selection and testing of product for substantiating
  and auditing a selected sterilization dose
6 Method VD[max][SD] - Substantiation of a selected
  sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5,
  or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1.0 VD[max][SD], SIP
  dose reduction factor and augmentation dose
  corresponding to applicable values of average bioburden
  for selected sterilization doses of 17.5, 20, 22.5, 27.5,
  30, 32.5 and 35 kGy
9 Worked examples
Bibliography

Specifies a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.

DevelopmentNote	Supersedes AAMI TIR33. (11/2017)
DocumentType	Standard
Pages	87
ProductNote	Reconfirmed 2013
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI/ISO TIR13004:2013(R2016)
Supersedes	AAMI TIR33 : 2005

Standards	Relationship
ISO/TS 13004:2013	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose