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
03-09-2009
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
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 |
| 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 |
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