ANSI/AAMI/ISO 11138-5:2017

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES

Available format(s): Hardcopy, PDF

Superseded date: 20-04-2024

Language(s): English

Published date: 01-08-2017

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 11138-5:2017
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 low-temperature steam and
        formaldehyde
Annex B (informative) - Rationale for
        the liquid-phase test method
        for low-temperature steam and
        formaldehyde biological
        indicators
Bibliography

Abstract - (Show below) - (Hide below)

Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

General Product Information - (Show below) - (Hide below)

Committee	ISO/TC 198
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	ANSI/AAMI/ISO 11138-5:2017(R2024)
Supersedes	AAMI ISO 11138-5 : 2006 : R2010

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 11138-5:2017	Identical

Standards Referencing This Book - (Show below) - (Hide below)

ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 25424:2009	Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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

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