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EN 867-4 : 2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

03-01-2007

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

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 injection 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.

Committee
TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
UNI EN 867-4 : 2003 Identical
I.S. EN 867-4:2000 Identical
UNE-EN 867-4:2001 Identical
SN EN 867-4 : 2001 Identical
NEN EN 867-4 : 2000 Identical
DIN EN 867-4:2001-02 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

BS EN 867-5:2001 Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS

EN 60584-2:1993 Thermocouples - Part 2: Tolerances
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 60751:2008 INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
EN 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
EN 867-1 : 1997 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - GENERAL REQUIREMENTS
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

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