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EN 867-3:1997/AC:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
Superseded date

03-01-2007

Published date

01-12-2013

Foreword
      Introduction
1 Scope
2 Normative references
3 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 after
                    steam sterilization
Annex B (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 C (normative) Method for determining colour change on
                    exposure to dry saturated steam
Annex D (normative) Method for determining indicator colour
                    change on exposure to dry heat
Annex E (normative) Ageing of test samples
Annex F (normative) Method for evaluating transfer of
                    indicator to standard test pack on
                    processing
Annex G (normative) Method for demonstrating the shelf life
                    of the product
Annex H (normative) Steam exposure apparatus
Annex J (normative) Method for determining the sensitivity
                    of the indicator to the presence of air
Annex K (normative) Air injection system
Annex L (normative) Standard test pack

Defines criteria for an indicator for use in the Bowie and Dick test for steam sterilizers for wrapped items, such as instruments and porous metals.

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Superseded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

Standards Relationship
UNI EN 867-3 : 1999 Identical
NF EN 867-3 : 1997 Identical
NEN EN 867-3 : 1997 C1 1998 Identical
UNE-EN 867-3/AC:1998 Identical
SN EN 867-3 : 1997 Identical
I.S. EN 867-3:1997 Identical
DIN EN 867-3:1997-05 Identical
BS EN 867-3:1997 Identical
NS EN 867-3 : 97 AC 98 Identical
NBN EN 867-3 : 1997 Identical

02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
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
I.S. EN ISO 11140-3:2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
AAMI ISO 11140-3 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
AAMI ISO 11140-3 : 2007 : R2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST
BS EN 867-4:2001 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
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

ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets
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
ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
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

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