ISO/TS 17665-2:2009
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
01-03-2024
Superseded by
Language(s)
English, French
Published date
05-01-2009
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1.
| Committee |
ISO/TC 198
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| DocumentType |
Technical Specification
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| Pages |
47
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| ProductNote |
THIS STANDARD ALSO REFERS TO ISO 11737-2
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| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy |
| Standards | Relationship |
| NF CEN ISO/TS 17665-2 : 2009 | Identical |
| NEN NPR CEN ISO/TS 17665-2 : 2009 | Identical |
| S.R. CEN ISO TS 17665-2:2009 | Identical |
| SNR CEN ISO/TS 17665-2 : 2017 | Identical |
| UNI CEN ISO/TS 17665-2 : 2009 | Identical |
| CSA Z17665-2:09 (R2019) | Identical |
| SIS-CEN ISO/TS 17665-2:2009 | Identical |
| UNE-CEN ISO/TS 17665-2:2009 EX | Identical |
| DD CEN ISO/TS 17665-2:2009 | Identical |
| CEN ISO/TS 17665-2:2009 | Identical |
| DIN ISO/TS 17665-2:2009-07 | Identical |
| DS CEN ISO/TS 17665-2 : 2009 | Identical |
| ONORM ONR CEN ISO/TS 17665-2 : 2009 | Identical |
| AAMI ISO TIR 17665-2 : 2009 | Identical |
| CSA Z17665-2 : 2009 : R2014 | Identical |
| AAMI/ISO TIR17665-2:2009(R2016) | Identical |
| CSA Z15882 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| DIN EN ISO 8638:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| BS EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| BS EN ISO 6710:2017 | Single-use containers for human venous blood specimen collection |
| AAMI ISO 11140-4 : 2007 | 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 |
| CSA ISO 8637 : 2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| CSA ISO 8637 : 2012 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| 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 |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| UNI EN ISO 13408-6 : 2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| 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) |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| BS EN ISO 11140-1:2014 | Sterilization of health care products. Chemical indicators General requirements |
| ISO 8638:2010 | Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) |
| EN ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| I.S. EN ISO 6710:2017 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| DIN EN ISO 13408-6:2013-07 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013) |
| 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 |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| AAMI ISO 11140-5 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS |
| AAMI ISO 11140-4 : 2007 : R2012 | 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 19979:2018 | Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses |
| CSA ISO 8638 : 2012 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| AAMI ISO 8638 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| BS EN ISO 13408-6 : 2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| AAMI ISO 8638 : 2010 : R2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| ISO 18362:2016 | Manufacture of cell-based health care products Control of microbial risks during processing |
| I.S. EN ISO 13408-6:2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005) |
| EN ISO 6710:2017 | Single-use containers for human venous blood specimen collection (ISO 6710:2017) |
| DIN EN 556-2:2015-11 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
| ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| I.S. EN ISO 11140-1:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| 16/30348158 DC : 0 | BS EN ISO 6710 - SINGLE-USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION |
| AAMI ISO 15882 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| BS EN ISO 8637:2014 | Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 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) |
| AAMI ISO 11140-5 : 2007 : R2012 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS |
| AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| I.S. EN ISO 8637:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
| I.S. EN ISO 8638:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| UNI EN ISO 8637 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| 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 |
| ISO 6710:2017 | Single-use containers for human venous blood specimen collection |
| 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 8536-4 : 2013 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
| UNI EN ISO 15882 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| DIN EN ISO 8637:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01) |
| 16/30331656 DC : 0 | BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
| I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| AAMI ISO 8637 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| CSA Z15882 :2009 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| 16/30280931 DC : DRAFT APR 2016 | BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| 16/30331653 DC : 0 | BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| AAMI ISO 13408-6:2005 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
| UNI EN ISO 8638 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN ISO 8637:2014 | Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01) |
| I.S. EN ISO 8536-4:2013 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010) |
| DIN EN ISO 8536-4:2013-07 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| UNE-EN 556-2:2016 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ANSI/AAMI/ISO 15882:2008(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| BS EN ISO 15882:2008 | Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN ISO 15882:2008 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) |
| 16/30331650 DC : 0 | BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| BS ISO 18362:2016 | Manufacture of cell-based health care products. Control of microbial risks during processing |
| 17/30326683 DC : DRAFT SEP 2017 | BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES |
| CSA ISO 8638 : 2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| 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 |
| BS ISO 19979:2018 | Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses |
| 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 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| ANSI/AAMI/ISO 11140-6:2024 | Sterilization of health care products— Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| 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 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| EN 868-5:2009 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| BS EN 12442-3:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
| EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
| BS EN 12442-2:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| EN 867-5:2001 | Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| 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 |
| EN 868-2:2017 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
| EN 868-3:2017 | Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO/TS 15883-5:2005 | Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| ISO 11140-4:2007 | 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/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 15883-4:2008 | Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 11140-5:2007 | Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 15883-2:2006 | Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN 13060:2014 | Small steam sterilizers |
| 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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