EN 867-4 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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- PART 4: SPECIFICATION FOR INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK TEST FOR THE DETECTION OF STEAM PENETRATION
01-03-2007
12-01-2013
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Superseded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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