UNE-EN ISO 11140-3:2009
Current
The latest, up-to-date edition.
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
Hardcopy , PDF
Spanish, Castilian, English
09-09-2009
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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) Determination of strength
after steam sterilization
Annex B (normative) Estimation of visual difference
between colour of the substrate and the
changed (or unchanged) indicator system by
determination of relative reflectance density
Annex C (normative) Determination of indicator colour
change on exposure to dry saturated steam
Annex D (normative) Determination of indicator colour
change on exposure to dry heat
Annex E (normative) Accelerated ageing of test samples
Annex F (normative) Determination of transfer of indicator
to standard test pack on processing
Annex G (normative) Determination of shelf life of the product
Annex H (normative) Steam exposure apparatus
Annex I (normative) Determination of sensitivity of the indicator
to the presence of air
Annex J (normative) Air injection system
Annex K (normative) Standard test pack
Bibliography
Describes the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 867-3. (07/2007)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11140-3:2007 | Identical |
| NF EN ISO 11140-3 : 2009 | Identical |
| NBN EN ISO 11140-3 : 2009 | Identical |
| NEN EN ISO 11140-3 : 2009 | Identical |
| NS EN ISO 11140-3 : 2009 | Identical |
| I.S. EN ISO 11140-3:2009 | Identical |
| SN EN ISO 11140-3:2009 | Identical |
| UNI EN ISO 11140-3 : 2009 | Identical |
| BS EN ISO 11140-3:2009 | Identical |
| EN ISO 11140-3:2009 | Identical |
| DIN EN ISO 11140-3:2009-09 | Identical |
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