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I.S. EN 867-4:2000

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NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - PART 4: SPECIFICATION FOR INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK TEST FOR THE DETECTION OF STEAM PENETRATION

Available format(s)

Hardcopy , PDF

Superseded date

18-04-2007

Language(s)

English

Published date

01-01-2000

Publisher

National Standards Authority of Ireland

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

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) Method for determining
          strength during and after steam
          sterlization
Annex B (normative) Standard test cycles
Annex C (normative) Method for the estimation
          of the visual difference between the
          colour of the substrate and the
          changed or unchanged indicator
          system by determination of the
          relative reflectance density
Annex D (normative) Method for demonstrating
          uniform colour change on exposure
          to saturated steam
Annex E (normative) Method for determining
          the equivalence of the alternative
          indicator to the Bowie and Dick
          test
Annex F (normative) Method for determining the
          reproducibility of fail conditions
          created in a standard test pack by
          air injection, air leak and retained
          air systems
Annex G (normative) Method for evaluating
          indicator colour change on exposure
          to dry heat
Annex H (normative) Method for demonstrating
          the shelf life of the product
Annex J (normative) Method for accelerated
          ageing of test samples
Annex K (normative) Steam exposure apparatus
          and steam for test purposes
Annex L (normative) Standard test pack
Annex M (normative) Air infection system
Bibliography

This Standard defines the performance requirements for a Class B indicator to be used as an alternative to the Bowie and Dick test for steam sterlizers for wrapped goods (instruments, etc. and porous loads). An indicator conforming to this Standard incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This Standard does not cover requirements for the test load but defines the performance of the indicator system in combination with the test load with which it is intended to be used.

DocumentType	Standard
Pages	40
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN 11140-4:2007

Standards	Relationship
SN EN 867-4 : 2001	Identical
EN 867-4 : 2000	Identical
NEN EN 867-4 : 2000	Identical
DIN EN 867-4:2001-02	Identical
UNE-EN 867-4:2001	Identical
NF EN 867-4 : 2001	Identical
NBN EN 867-4 : 2001	Identical
NS EN 867-4 : 1ED 2001	Identical
BS EN 867-4:2001	Identical
UNI EN 867-4 : 2003	Identical