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AAMI
ANSI/AAMI/ISO 11138-3:2017

ANSI/AAMI/ISO 11138-3:2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

04-20-2024

Language(s)

English

Published date

08-01-2017

Publisher

Association for the Advancement of Medical Instrumentation

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Superseded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

ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES

ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Hardcopy - English
PDF - English - DRM
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