ISO 11137-3:2017
Current
Current
The latest, up-to-date edition.
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
French, English
Published date
26-06-2017
$333.56
Including GST where applicable
ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Together with ISO 11137-1 and ISO 11137-2, Supersedes ISO 11137. (05/2006) Supersedes ISO/DIS 11137-3. (06/2017)
|
| DocumentType |
Standard
|
| Pages |
45
|
| ProductNote |
THIS STANDARD ALSO REFERS TO JCGM 106,GUM:1995, JCGM 100,
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| JIS T 0806-3:2022 | Identical |
| DIN EN ISO 11137-3:2017-11 | Identical |
| NF EN ISO 11137-3 : 2017 | Identical |
| NEN EN ISO 11137-3 : 2017 | Identical |
| NS EN ISO 11137-3 : 2017 | Identical |
| I.S. EN ISO 11137-3:2017 | Identical |
| PN EN ISO 11137-3 : 2017 | Identical |
| SS-EN ISO 11137-3:2017 | Identical |
| IS/ISO 11137 : Part 3:2017 | Identical |
| BS EN ISO 11137-3:2017 | Identical |
| EN ISO 11137-3:2017 | Identical |
| DIN EN ISO 11137-3:2015-08 (Draft) | Identical |
| ANSI/AAMI/ISO 11137-3:2017 | Identical |
| UNE-EN ISO 11137-3:2018 | Identical |
| GOST R ISO 11137-3 : 2008 | Identical |
| UNE-EN ISO 11137-3:2007 | Identical |
| AAMI ISO 11607-1 : 2006 : R2010 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| 14/30270462 DC : 0 | BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| 16/30331650 DC : 0 | BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| I.S. EN ISO 11137-1:2015 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| DIN EN ISO 5840-3:2013-06 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| DIN EN ISO 8638:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| 16/30302485 DC : 0 | BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT |
| BS EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| 17/30351717 DC : 0 | BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| S.R. CEN ISO/TS 13004:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] (ISO/TS 13004:2013) |
| AAMI ISO 13408-1 : 2008 : R2011 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ONORM EN ISO 5840-3 : 2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| AAMI ISO 11607-1 : 2006 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| ANSI/AAMI/ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
| PREN ISO 11137-2 : DRAFT 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| 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) |
| ISO 14470:2011 | Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food |
| AAMI ISO 11137-1:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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 |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| ISO 13408-1:2008 | Aseptic processing of health care products — 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) |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| ANSI/AAMI/ ISO 11137-2:2013(R2019) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| 13/30264511 DC : 0 | BS ISO/ASTM 52628 - STANDARD PRACTICE FOR DOSIMETRY IN RADIATION PROCESSING |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 15/30321502 DC : 0 | BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5840-3:2013 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| BS ISO 14470:2011 | Food irradiation. Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food |
| 04/30048584 DC : DRAFT MAY 2004 | BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| BS PD ISO/TS 13004 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] |
| ISO/ASTM 52628:2013 | Standard practice for dosimetry in radiation processing |
| BS EN ISO 13408-1:2015 | Aseptic processing of health care products General requirements |
| AAMI ISO 11137-2 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| AAMI ISO 8638 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| AAMI ISO 8638 : 2010 : R2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| AAMI ISO 11737-1 : 2006 : R2011 | STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
| 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 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| 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 11137-2:2015 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013) |
| DIN EN ISO 11137-2:2015-11 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| I.S. EN ISO 10451:2010 | DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| DIN EN ISO 11607-1:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
| 09/30180393 DC : 0 | BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| BS EN ISO 5840-3:2013 | Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
| BS EN ISO 8637:2014 | Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 07/30090385 DC : 0 | ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ANSI/AAMI/ISO TIR13004:2013(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] |
| 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) |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| I.S. EN ISO 8638:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| BS EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| BS EN ISO 11137-1:2015 | Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| 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) |
| AAMI ISO 11737-1 : 2006 | STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
| 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 |
| ANSI/AAMI/ISO 11607-1:2006/(R)2015 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 16/30331653 DC : 0 | BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| PD CEN ISO/TS 13004:2014 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VD<sub>max</sub>SD |
| AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| 09/30197784 DC : 0 | BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| AAMI ISO 13408-1:2008 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO/ASTM 51649:2015 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
| 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 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| BS EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants — General requirements |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| ISO 5840-3:2013 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques |
| ISO 14534:2011 | Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements |
| BS EN ISO 10451:2010 | Dentistry. Contents of technical file for dental implant systems |
| ISO 10451:2010 | Dentistry — Contents of technical file for dental implant systems |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 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 10451:2010 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| 16/30331656 DC : 0 | BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| I.S. EN ISO 13408-1:2015 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| 04/30048301 DC : DRAFT MAY 2004 | BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ISO 11137-1 : 2006 : R2010 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| AAMI ISO TIR 13004 :2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE: METHOD VD[MAX][SD] |
| I.S. EN ISO 11607-1:2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
| BS EN ISO 11607-1 : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| ISO 15798:2013 | Ophthalmic implants — Ophthalmic viscosurgical devices |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| DIN EN ISO 10451:2010-11 | Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
| BS EN ISO 11137-2:2015 | Sterilization of health care products. Radiation Establishing the sterilization dose |
| CEN ISO/TS 13004:2014 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013) |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| I.S. EN ISO 11137-1:2015/A2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137- 1:2006/Amd 2:2018) |
| I.S. EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| UNE-EN ISO 5840-3:2013 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
| UNE-EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 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 |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| UNE-EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) |
| UNE-EN ISO 11140-1:2015 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| UNE-EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| ONORM EN 794-3 : 2010 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| ISO/TS 13004:2013 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO/ASTM 51401:2013 | Practice for use of a dichromate dosimetry system |
| ISO/ASTM 51650:2013 | Practice for use of a cellulose triacetate dosimetry system |
| ISO 11462-2:2010 | Guidelines for implementation of statistical process control (SPC) — Part 2: Catalogue of tools and techniques |
| ISO/ASTM 51276:2012 | Practice for use of a polymethylmethacrylate dosimetry system |
| ISO/ASTM 52303:2015 | Guide for absorbed-dose mapping in radiation processing facilities |
| ISO/ASTM 51818:2013 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
| ISO/ASTM 51261:2013 | Practice for calibration of routine dosimetry systems for radiation processing |
| ISO 14253-1:2017 | Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/ASTM 51275:2013 | Practice for use of a radiochromic film dosimetry system |
| ISO/ASTM 51608:2015 | Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV |
| ASTM E 2232 : 2016 : REDLINE | Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications |
| ISO/ASTM 52701:2013 | Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO/ASTM 51607:2013 | Practice for use of the alanine-EPR dosimetry system |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO/ASTM 51649:2015 | Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
| ISO/ASTM 51707:2015 | Guide for estimation of measurement uncertainty in dosimetry for radiation processing |
| ISO/ASTM 52628:2013 | Standard practice for dosimetry in radiation processing |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO/ASTM 51631:2013 | Practice for use of calorimetric dosimetry systems for electron beam dose measurements and dosimetery system calibrations |
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