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UNI EN 867-4 : 2003

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Superseded date

11-10-2007

Published date

12-01-2013

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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) 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
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy

Standards Relationship
UNE-EN 867-4:2001 Identical
BS EN 867-4:2001 Identical
DIN EN 867-4:2001-02 Identical
EN 867-4 : 2000 Identical
I.S. EN 867-4:2000 Identical

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