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ISO 11140-5:2007

Current

Current

The latest, up-to-date edition.

Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

15-03-2007

€60.00
Excluding VAT

ISO 11140-5:2007 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.

Additionally, ISO 11140-5:2007 includes test methods and equipment used to meet these performance requirements.

Committee
ISO/TC 198
DevelopmentNote
Supersedes ISO/DIS 11140-5. (03/2007)
DocumentType
Standard
Pages
12
PublisherName
International Organization for Standardization
Status
Current
Supersedes

CSA Z15882 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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
PREN ISO 11140-1 : DRAFT 2012 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012)
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)
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
CSA Z314.3 : 2009 : R2014 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
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 ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
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)
12/30238553 DC : 0 BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
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
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 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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
DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
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
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
ANSI/AAMI/ISO 20857:2010(R2015) STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
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
16/30330536 DC : 0 BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
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 Z314.3 : 2009 EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
CAN/CSA-Z314-18 Canadian medical device reprocessing
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)
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)
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
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
UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
07/30164697 DC : 0 ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
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 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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
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 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
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
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 18472:2006-10 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
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
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
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
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)

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ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
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
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