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I.S. 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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Preview

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.

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

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 I.S. EN 867-3. (07/2007)
DocumentType
Standard
Pages
34
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

ISO 5636-3:2013 Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 187:1990 Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 5-4:2009 Photography and graphic technology Density measurements Part 4: Geometric conditions for reflection density
ISO 5457:1999 Technical product documentation Sizes and layout of drawing sheets
ISO 5-3:2009 Photography and graphic technology Density measurements Part 3: Spectral conditions
ISO 5-1:2009 Photography and graphic technology Density measurements Part 1: Geometry and functional notation
ISO 9001:2015 Quality management systems — Requirements
ISO/CIE 10526:1999 CIE standard illuminants for colorimetry
EN 867-3:1997/AC:1998 NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - SPECIFICATION FOR CLASS B INDICATORS FOR USE IN THE BOWIE AND DICK TEST
ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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