Name: UNI EN ISO 11140-3 : 2009
Brand: UNI

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

03-09-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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.

Committee	CT 44
DevelopmentNote	Supersedes UNI EN 867-3. (10/2007)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 11140-3 : 2007 UNI EN 867-3 : 1999

Standards	Relationship
SN EN ISO 11140-3:2009	Identical
NF EN ISO 11140-3 : 2009	Identical
I.S. EN ISO 11140-3:2009	Identical
DIN EN ISO 11140-3:2009-09	Identical
ISO 11140-3:2007	Identical
NBN EN ISO 11140-3 : 2009	Identical
BS EN ISO 11140-3:2009	Identical
EN ISO 11140-3:2009	Identical
UNE-EN ISO 11140-3:2009	Identical
NS EN ISO 11140-3 : 2009	Identical
NEN EN ISO 11140-3 : 2009	Identical

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
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