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)
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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.
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Sisällysluettelo
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 Determination of strength after steam sterilization (normative)
Annex B Estimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density (normative)
Annex C Determination of indicator colour change on exposure to dry saturated steam (normative)
Annex D Determination of indicator colour change on exposure to dry heat (normative)
Annex E Accelerated ageing of test samples (normative)
Annex F Determination of transfer of indicator to standard test pack on processing (normative)
Annex G Determination of shelf life of the product (normative)
Annex H Steam exposure apparatus (normative)
Annex I Determination of sensitivity of the indicator to the presence of air (normative)
Annex A Determination of strength after steam sterilization (normative)
Annex B Estimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density (normative)
Annex C Determination of indicator colour change on exposure to dry saturated steam (normative)
Annex D Determination of indicator colour change on exposure to dry heat (normative)
Annex E Accelerated ageing of test samples (normative)
Annex F Determination of transfer of indicator to standard test pack on processing (normative)
Annex G Determination of shelf life of the product (normative)
Annex H Steam exposure apparatus (normative)
Annex I Determination of sensitivity of the indicator to the presence of air (normative)
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers
ISO 10526:1999
ISO 11140-1:2005 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers
ISO 10526:1999
ISO 11140-1:2005 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
ISO 187:1990 Paper, board and pulps -- Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples
ISO 2248:1985 Packaging -- Complete, filled transport packages -- Vertical impact test by dropping
ISO 5-1:1984 Photography -- Density measurements -- Part 1: Terms, symbols and notations
ISO 5-3:1995 Photography -- Density measurements -- Part 3: Spectral conditions
ISO 5-4:1995 Photography -- Density measurements -- Part 4: Geometric conditions for reflection density
ISO 5457:1999 Technical product documentation -- Sizes and layout of drawing sheets
ISO 5636-3:1992 Paper and board -- Determination of air permeance (medium range) -- Part 3: Bendtsen method