Name: AAMI TIR40 : 2018
Brand: AAMI
Price: 177.00 USD

AAMI TIR40 : 2018

Superseded

View Superseded by

STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON DOSE SETTING UTILIZING A MODIFIED METHOD 2

Available format(s)

Hardcopy , PDF

Superseded date

04-09-2024

Language(s)

English

Published date

01-31-2018

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Normative References
3 Abbreviations, terms, and definitions
4 Modified Method 2 - Application for method
5 Modified Method 2: Dose setting using fraction positive
information from incremental dosing to determine an
extrapolation factor
6 Procedure for Modified Method 2A
7 Procedure for Modified Method 2B
8 Auditing sterilization dose
9 Worked examples
Bibliography

Defines a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL).

DocumentType	Standard
ISBN	978-1-57020-694-8
Pages	27
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	AAMI TIR40:2018(R2022)
Supersedes	AAMI TIR40 : 2009 : R2016

AAMI ISO 11137-2 : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
AAMI ISO TIR 11139 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
AAMI ST32 : 1991	GUIDELINE FOR GAMMA RADIATION STERILIZATION