ISO 11138-4:2017
Current
Current
The latest, up-to-date edition.
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
03-03-2017
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ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
| DevelopmentNote |
Supersedes ISO/DIS 11138-4. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11138-4 : 2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| PN EN ISO 11138-4 : 2017 | Identical |
| SN EN ISO 11138-4 : 2017 | Identical |
| UNI EN ISO 11138-4 : 2006 | Identical |
| UNI EN ISO 11138-4 : 2017 | Identical |
| SS-EN ISO 11138-4 : 2017 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |
| BS EN ISO 11138-4:2017 | Identical |
| EN ISO 11138-4:2017 | Identical |
| ANSI/AAMI/ISO 11138-4:2017 | Identical |
| CAN/CSA-ISO 11138-4:17 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| DIN EN ISO 11138-4:2017-07 | Identical |
| ANSI/AAMI/ISO 11138-4:2017(R2024) | Identical |
| ABNT NBR ISO 11138-4:2023 | Identical |
| SAC GB 18281.4 : 2015 | Identical |
| NBR ISO 11138-4 : 2016 | Identical |
| 17/30363625 DC : DRAFT SEP 2017 | BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| 08/30149503 DC : DRAFT JAN 2008 | BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| CSA Z1416: 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| 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) |
| ONORM EN ISO 18472 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| 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 |
| UNE-EN ISO 14161:2010 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| BS EN ISO 14161:2009 | Sterilization of health care products. Biological indicators. Guidance for the 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) |
| 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 |
| 04/30078095 DC : DRAFT JUL 2004 | ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA Z14161 : 2011 : R2015 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| 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) |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| 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 |
| NF 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 |
| UNE-EN ISO 11140-1:2015 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| I.S. EN ISO 14161:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| EN ISO 14161:2009 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
| UNI EN ISO 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| 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) |
| 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 |
| 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 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
| DIN EN ISO 14161:2010-03 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| 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 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) |
| 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) |
| DIN EN ISO 18472:2006-10 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| 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 |
| 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 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 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| 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 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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