I.S. 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
Hardcopy , PDF
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC
Bibliography
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