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ANSI/AAMI/ISO 11138-5:2017

Current
Current

The latest, up-to-date edition.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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

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.

Committee
ISO/TC 198
DocumentType
Standard
ISBN
978-1-57020-682-5
Pages
19
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 11138-5:2017 Identical

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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