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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 (ISO 11140-3:2007, including Cor 1:2007)
Published date

05-06-2009

Publisher

Comite Europeen de Normalisation

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.

DevelopmentNote
Supersedes EN 867-3. (03/2007)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

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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