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 (ISO 11140-3:2007, including Cor 1:2007)
06-05-2009
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
ISO 11140-3:2007 specifies 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. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.
| Committee |
CEN/TC 102
|
| DevelopmentNote |
Supersedes EN 867-3. (03/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| 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 |
| SS-EN ISO 11140-3:2009 | Identical |
| UNI EN ISO 11140-3 : 2009 | Identical |
| ISO 11140-3:2007 | Identical |
| PN EN ISO 11140-3 : 2011 | Identical |
| NBN EN ISO 11140-3 : 2009 | Identical |
| BS 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 |
| I.S. EN 15424:2007 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| BS EN 15424:2007 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| STANAG 2906 : 2015 | ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| 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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