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NS EN ISO 11140-3 : 2009

Current
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
Published date

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) 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.

DevelopmentNote
Supersedes NS EN 867-3. (07/2007)
DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

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