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DIN EN 867-4:2001-02

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

01-07-2007

Language(s)

English

Published date

12-01-2013

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 is included in DIN Handbook 263. 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
36
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

Standards Relationship
ISO 11140-4:2007 Corresponds
I.S. EN 867-4:2000 Identical
UNI EN 867-4 : 2003 Identical
UNE-EN 867-4:2001 Identical
SN EN 867-4 : 2001 Identical
EN 867-4 : 2000 Identical
NEN EN 867-4 : 2000 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

DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES

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