ISO 11140-4:2007
Current
Current
The latest, up-to-date edition.
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
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
03-15-2007
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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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11140-4. (03/2007)
|
| DocumentType |
Standard
|
| Pages |
35
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ANSI/AAMI/ISO 11140-4:2007(R2015) | Identical |
| GOST ISO 11140-4 : 2011 | Identical |
| NF EN ISO 11140-4 : 2007 | Identical |
| NBN EN ISO 11140-4 : 2007 | Identical |
| NEN EN ISO 11140-4 : 2007 | Identical |
| NS EN ISO 11140-4 : 1ED 2007 | Identical |
| I.S. EN 11140-4:2007 | Identical |
| PN EN ISO 11140-4 : 2009 | Identical |
| SN EN ISO 11140-4 : 2007 | Identical |
| UNI EN ISO 11140-4 : 2007 | Identical |
| SS-EN ISO 11140-4:2007 | Identical |
| UNE-EN ISO 11140-4:2007 | Identical |
| BS EN ISO 11140-4:2007 | Identical |
| EN ISO 11140-4:2007 | Identical |
| DIN EN ISO 11140-4:2007-07 | Identical |
| AAMI ISO 11140-4 : 2007 : R2012 | Identical |
| CAN/CSA-ISO 11140-4:18 | Identical |
| GOST R ISO 11140-4 : 2006 | Identical |
| AAMI ISO 11140-4 : 2007 | Identical |
| DIN EN 867-4:2001-02 | Corresponds |
| PREN ISO 11140-1 : DRAFT 2012 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012) |
| CSA Z15882 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| 05/30138310 DC : DRAFT AUG 2005 | ISO 15882 ED 2 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| ONORM EN ISO 18472 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| CSA Z17665-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN ISO 11140-1:2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| BS EN ISO 11140-1:2014 | Sterilization of health care products. Chemical indicators General requirements |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| DIN EN ISO 15882:2008-12 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| EN ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| I.S. EN 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 |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| 12/30238553 DC : 0 | BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| 04/30048205 DC : DRAFT JUL 2004 | BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| BS EN ISO 18472:2006 | Sterilization of health care products. Biological and chemical indicators. Test equipment and methods |
| EN ISO 18472:2006 | Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006) |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| I.S. EN ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
| I.S. EN ISO 11140-1:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
| I.S. EN ISO 15882:2008 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| 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 |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 16/30330536 DC : 0 | BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| CSA Z15882 :2009 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| AAMI ISO 15882 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| CSA Z15882:09 (R2019) | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01) |
| CAN/CSA-Z314-18 | Canadian medical device reprocessing |
| ANSI/AAMI ISO 17665-1:2006(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z17665-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| UNE-EN ISO 11140-1:2015 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| UNI EN ISO 15882 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| CSA Z17665-1:09 (R2019) | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| I.S. EN ISO 18472:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ANSI/AAMI/ISO 15882:2008(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| BS EN ISO 17665-1:2006 | Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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 |
| ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| BS EN ISO 15882:2008 | Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results |
| EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| EN 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 (ISO 17665-1:2006) |
| EN ISO 15882:2008 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| S.R. CEN ISO TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI 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 |
| AAMI ISO 18472 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| CSA ISO 11140-1 : 2016 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| 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 11140-3:2007 | 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 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 5-3:2009 | Photography and graphic technology Density measurements Part 3: Spectral conditions |
| IEC 60751:2008 | Industrial platinum resistance thermometers and platinum temperature sensors |
| 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 10012-1:1992 | Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| 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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