STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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.

DevelopmentNote	Supersedes I.S. EN 866-5. (09/2006)
DocumentType	Standard
Pages	24
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11138-5:2006

Standards	Relationship
EN ISO 11138-5:2017	Identical
NEN EN ISO 11138-5 : 2017	Identical
UNI EN ISO 11138-5 : 2006	Identical
NS EN ISO 11138-5 : 2017	Identical
SN EN ISO 11138-5 : 2017	Identical
DIN EN ISO 11138-5:2015-10 (Draft)	Identical
NBN EN ISO 11138-5 : 2006	Identical
ISO 11138-5:2017	Identical
BS EN ISO 11138-5:2017	Identical
UNE-EN ISO 11138-5:2017	Identical
NF EN 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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I.S. EN ISO 11138-5:2017

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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