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ANSI/AAMI/ISO 11138-3:2017

Superseded

Superseded

View Superseded by

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES

Available format(s)

PDF

Language(s)

English

Published date

08-01-2017

Superseded date

04-20-2024

US$129.00
Excluding Tax where applicable
Summarise this standard

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
 ISO 11138-3:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination
        of resistance to moist heat sterilization
Annex B (normative) - Calculation of z value
        and coefficient of determination, r[2]
Bibliography

Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

DevelopmentNote
Supersedes AAMI ST19 (08/2006)
DocumentType
Test Method
ISBN
978-1-57020-680-1
Pages
21
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11138-3:2017 Identical

⚠

A newer version of this standard is available.

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US$129.00
Excluding Tax where applicable