Sterilization of health care products. Chemical indicators. Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
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ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.
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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 indicator strength during and after steam sterilization (normative)
Annex B Standard test cycles (normative)
Annex C Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectance density (normative)
Annex D Determination of uniform colour change on exposure to saturated steam (normative)
Annex E Determination of equivalence of the alternative indicator to the Bowie and Dick test (normative)
Annex F Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retained air systems (normative)
Annex G Determination of indicator colour change on exposure to dry heat (normative)
Annex H Determination of shelf life of product (normative)
Annex I Accelerated ageing of test samples (normative)
Annex J Steam exposure apparatus and steam for test purposes (normative)
Annex A Determination of indicator strength during and after steam sterilization (normative)
Annex B Standard test cycles (normative)
Annex C Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectance density (normative)
Annex D Determination of uniform colour change on exposure to saturated steam (normative)
Annex E Determination of equivalence of the alternative indicator to the Bowie and Dick test (normative)
Annex F Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retained air systems (normative)
Annex G Determination of indicator colour change on exposure to dry heat (normative)
Annex H Determination of shelf life of product (normative)
Annex I Accelerated ageing of test samples (normative)
Annex J Steam exposure apparatus and steam for test purposes (normative)
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers
IEC 60584-2 AMD 1:1989
IEC 60584-2:1982
EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers
IEC 60584-2 AMD 1:1989
IEC 60584-2:1982
IEC 60751 AMD 1:1986
IEC 60751:1983
ISO 10012-1:1992 Quality assurance requirements for measuring equipment -- Part 1: Metrological confirmation system for measuring equipment
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/CIE 10526:1991 CIE standard colorimetric illuminants