• DIN EN 867-4:2001-02

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  01-07-2007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

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

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