15/30321511 DC : 0

Superseded

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BS EN ISO 11138-4 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES

Available format(s): Hardcopy, PDF

Superseded date: 30-04-2017

Language(s): English

Published date:

Publisher: British Standards Institution

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

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

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BS EN ISO 11138-4.

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Comment Closes On
Committee	CH/198
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11138-4:2017

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

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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