STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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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 dry heat sterilization
Annex B (normative) - Calculation of z value
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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 degrees C to 180 degrees C.

DevelopmentNote	Supersedes I.S. EN 866-6. (09/2006)
DocumentType	Standard
Pages	26
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11138-4:2006

Standards	Relationship
SN EN ISO 11138-4 : 2017	Identical
BS EN ISO 11138-4:2017	Identical
NBN EN ISO 11138-4 : 2006	Identical
NS EN ISO 11138-4 : 2017	Identical
UNI EN ISO 11138-4 : 2006	Identical
UNE-EN ISO 11138-4:2017	Identical
NEN EN ISO 11138-4 : 2017	Identical
DIN EN ISO 11138-4:2015-10 (Draft)	Identical
EN ISO 11138-4:2017	Identical
ISO 11138-4:2017	Identical
NF EN ISO 11138-4 : 2017	Identical

ISO 18472:2006	Sterilization of health care products Biological and chemical indicators Test equipment
ISO 20857:2010	Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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 11138-4:2017

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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Subcategory

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