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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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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

Available format(s): Hardcopy, PDF

Superseded date: 30-04-2007

Language(s): English

Published date: 15-01-2001

Publisher: British Standards Institution

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 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)

Committee	CH/198
Development Note	Supersedes BS 7720(1995). (12/2000) Supersedes 97/126609 DC (03/2005)
Document Type	Standard
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11140-4:2007
Supersedes	BS 7720:1995 97/126609 DC : DEC 97

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	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

Standards Referencing This Book - (Show below) - (Hide below)

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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