STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2007

Publisher

National Standards Authority of Ireland

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labelling
8 Quality assurance
Annex A (normative) Determination of indicator strength
        during and after steam sterilization
Annex B (normative) Standard test cycles
Annex C (normative) Estimation of visual difference
        between colour of the substrate and of the
        changed or unchanged indicator system by
        determination of relative reflectance density
Annex D (normative) Determination of uniform colour change
        on exposure to saturated steam
Annex E (normative) Determination of equivalence of the
        alternative indicator to the Bowie and Dick test
Annex F (normative) Determination of reproducibility of
        fail conditions created in a standard test pack
        by air injection, air leak and retained air systems
Annex G (normative) Determination of indicator colour change
        on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated ageing of test samples
Annex J (normative) Steam exposure apparatus and steam for
        test purposes
Annex K (normative) Standard test pack
Annex L (normative) Air injection system
Bibliography

Describes the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).

DevelopmentNote	Supersedes I.S. EN 867-4. (07/2007)
DocumentType	Standard
Pages	46
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN 867-4:2000

Standards	Relationship
SN EN ISO 11140-4 : 2007	Identical
ISO 11140-4:2007	Identical
BS EN ISO 11140-4:2007	Identical
UNE-EN ISO 11140-4:2007	Identical
NF EN ISO 11140-4 : 2007	Identical
DIN EN ISO 11140-4:2007-07	Identical
NBN EN ISO 11140-4 : 2007	Identical
NS EN ISO 11140-4 : 1ED 2007	Identical
EN ISO 11140-4:2007	Identical
UNI EN ISO 11140-4 : 2007	Identical
NEN EN ISO 11140-4 : 2007	Identical

ISO 5636-3:2013	Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 15882:2008	Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
ISO 11140-3:2007	Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 187:1990	Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 5-4:2009	Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5-3:2009	Photography and graphic technology Density measurements Part 3: Spectral conditions
IEC 60751:2008	Industrial platinum resistance thermometers and platinum temperature sensors
ISO 5-1:2009	Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015	Quality management systems — Requirements
ISO/CIE 10526:1999	CIE standard illuminants for colorimetry
ISO 2248:1985	Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 10012-1:1992	Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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I.S. EN 11140-4:2007

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Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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