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BS EN 867-4:2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

04-30-2007

Language(s)

English

Published date

01-15-2001

Publisher

British Standards Institution

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.

Committee
CH/198
DevelopmentNote
Supersedes BS 7720(1995). (12/2000) Supersedes 97/126609 DC (03/2005)
DocumentType
Standard
Pages
42
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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

EN 60584-2:1993 Thermocouples - Part 2: Tolerances
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
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)
ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015 Quality management systems — Requirements
EN 867-3:1997/AC:1998 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
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
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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