UNE-EN ISO 11140-4:2007
Current
The latest, up-to-date edition.
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
Hardcopy , PDF
Spanish, Castilian, English
19-09-2007
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 indicator strength
during and after steam sterilization
Annex B (normative) Standard test cycles
Annex C (normative) Estimation of visual difference
between colour of the substrate and of the
changed or unchanged indicator system by
determination of relative reflectance density
Annex D (normative) Determination of uniform colour change
on exposure to saturated steam
Annex E (normative) Determination of equivalence of the
alternative indicator to the Bowie and Dick test
Annex F (normative) Determination of reproducibility of
fail conditions created in a standard test pack
by air injection, air leak and retained air systems
Annex G (normative) Determination of indicator colour change
on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated ageing of test samples
Annex J (normative) Steam exposure apparatus and steam for
test purposes
Annex K (normative) Standard test pack
Annex L (normative) Air injection system
Bibliography
Describes the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 867-4. (09/2007)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 11140-4:2007-07 | Identical |
| ISO 11140-4:2007 | Identical |
| NF EN ISO 11140-4 : 2007 | Identical |
| NBN EN ISO 11140-4 : 2007 | Identical |
| I.S. EN 11140-4:2007 | Identical |
| NS EN ISO 11140-4 : 1ED 2007 | Identical |
| EN ISO 11140-4:2007 | Identical |
| BS EN ISO 11140-4:2007 | Identical |
| NEN EN ISO 11140-4 : 2007 | Identical |
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