EN 867-3:1997/AC:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
03-01-2007
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Superseded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 |
| 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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