UNI 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
09-03-2009
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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