ISO 11135:2014
Current
Current
The latest, up-to-date edition.
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
07-07-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11135, ISO 11135-1 and ISO TS 11135-2. (07/2014)
|
| DocumentType |
Standard
|
| Pages |
78
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| JIS T 0801:2016 | Identical |
| AAMI TIR74 : 2016 | Identical |
| UNI EN ISO 11135:2020 | Identical |
| NF EN ISO 11135:2014 | Identical |
| NBN EN ISO 11135 : 2014 | Identical |
| UNE-EN ISO 11135:2015 | Identical |
| ANSI/AAMI/ISO 11135:2014 | Identical |
| NEN EN ISO 11135 : 2014 | Identical |
| EN ISO 11135:2014 | Identical |
| GOST ISO 11135 : 2012 | Identical |
| ONORM EN ISO 11135 : 2015 | Identical |
| SS-EN ISO 11135:2014 | Identical |
| I.S. EN ISO 11135:2014 | Identical |
| SN EN ISO 11135 : 2014 | Identical |
| BS EN ISO 11135:2014 | Identical |
| UNI EN ISO 11135 : 2014 | Identical |
| DIN EN ISO 11135:2014-10 | Identical |
| PN EN ISO 11135 : 2014 | Identical |
| NS EN ISO 11135 : 2014 | Identical |
| I.S. EN ISO 11135:2014&A1:2019 | Identical |
| SAC GB 18279 : 2000 | Identical |
| CSA ISO 11135 : 1998:R2003 | Identical |
| GOST R ISO 11135 : 2000 | Identical |
| 03/108542 DC : DRAFT MAY 2003 | BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| AAMI RD17 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| 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 |
| I.S. EN ISO 5840:2009 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| 08/30184486 DC : DRAFT JUNE 2008 | BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
| 14/30255135 DC : 0 | BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| BS EN ISO 1135-5:2015 | Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus |
| 13/30276989 DC : 0 | BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS |
| I.S. EN ISO 22442-3:2007 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| I.S. EN 13503-8:2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| I.S. EN ISO 1135-5:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
| I.S. EN ISO 11737-1:2018&LC:2018 | STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018) |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 02/564514 DC : DRAFT OCT 2002 | BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
| DIN EN ISO 7197:2009-08 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| 17/30336573 DC : 0 | BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE |
| 14/30287226 DC : 0 | BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| 13/30284721 DC : 0 | BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
| ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| 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 |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| 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 |
| 02/565247 DC : DRAFT DEC 2002 | ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| BS ISO 14972:1998 | Sterile obturators for single use with over-needle peripheral intravascular catheters |
| AAMI ISO 22442-3:2007 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| ASTM F 2560 : 2006 | Standard Specification for Supralaryngeal Airways and Connectors |
| CSA Z11140.1 : 2007 : R2012 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| AAMI ISO 11607-1 : 2006 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| CAN/CSA-ISO 11138-2:17 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03) |
| ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| AAMI ISO 13408-2 : 2003 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
| CSA ISO 7199 : 0 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| I.S. EN ISO 18369-1:2017 | OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS (ISO 18369-1:2017, CORRECTED VERSION 2017-10-01) |
| AAMI ISO 5840-1 : 2016 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
| I.S. EN ISO 5840-1:2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| ANSI/AAMI/ISO 15674:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 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 1135-3:2017 | Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) |
| CSA ISO 10993-7 : 1998 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| DIN EN ISO 11140-1:2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| UNE-EN ISO 11138-2:2017 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017) |
| BS EN ISO 8536-9:2015 | Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment |
| ISO 7198:2016 | Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
| BS EN ISO 11140-1:2014 | Sterilization of health care products. Chemical indicators General requirements |
| BS EN ISO 22803:2005 | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| BS EN ISO 11138-2:2017 | Sterilization of health care products. Biological indicators Biological indicators for ethylene oxide sterilization processes |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| I.S. EN ISO 8536-9:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| EN 13503-8 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| CEN ISO/TR 14969:2005 | Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
| EN ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| BS ISO 19611:2017 | Traditional Chinese medicine. Air extraction cupping device |
| 02/560598 DC : DRAFT FEB 2002 | ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES |
| 17/30359001 DC : 0 | BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| 16/30310656 DC : 0 | BS EN ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS |
| BS EN ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ANSI/AAMI/ISO 11138-2:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
| CSA Z8638 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
| ANSI/AAMI/ISO 15675:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| 04/30078095 DC : DRAFT JUL 2004 | ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| 08/30179586 DC : DRAFT MAR 2008 | BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| BS ISO 10651-5:2006 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators |
| DIN EN ISO 1135-5:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
| ISO 20696:2018 | Sterile urethral catheters for single use |
| 15/30321502 DC : 0 | BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| BS ISO 15378 : 2006 AMD 17315 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
| 15/30321715 DC : 0 | BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 13/30284770 DC : 0 | BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| BS EN ISO 7199:2017 | Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) |
| I.S. EN ISO 13408-2:2018 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
| 15/30321712 DC : 0 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| 15/30321957 DC : 0 | BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| CSA ISO 11712 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS |
| 03/103026 DC : DRAFT JAN 2003 | BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| 14/30266295 DC : 0 | BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| AAMI ISO 5840 : 2005 : R2010 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| BS ISO 15674:2009 | Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| 08/30179592 DC : DRAFT MAR 2008 | BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
| 16/30302520 DC : 0 | BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE |
| AAMI ISO 5840 :2005 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| CSA Z11138-1 : 2007 : R2012 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| CAN/CSA-ISO 11138-1:17 | Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03) |
| AAMI ISO 22442-3 : 2007 : R2011 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| UNE-EN ISO 15378:2016 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015) |
| I.S. EN ISO 5361:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
| BS EN ISO 17664:2017 | Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 11712:2009 | Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ANSI/AAMI/ISO 15676:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) |
| AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNE-EN ISO 1135-5:2016 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
| CSA ISO 11712:14 (R2019) | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15) |
| AAMI ISO 13408-2 : 2003 : R2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
| ASTM F 2407 : 2006 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| 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 |
| DIN EN ISO 1135-4:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| DIN EN ISO 22442-3:2008-03 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| DIN EN ISO 22803:2006-01 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' Requirements for aseptically processed medical devices |
| BS EN ISO 11138-1:2017 | Sterilization of health care products. Biological indicators General requirements |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| I.S. EN ISO 8536-11:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| I.S. EN ISO 21649:2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 1135-4:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| I.S. EN ISO 11140-1:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
| ONORM EN ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| EN ISO 5840-1:2015 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| I.S. EN ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| I.S. EN ISO 11138-2:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| DIN EN ISO 1135-3:2017-05 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| ISO 20697:2018 | Sterile drainage catheters and accessory devices for single use |
| 03/104519 DC : DRAFT FEB 2003 | BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| BS ISO 15675:2009 | Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters |
| ISO 11737-3:2004 | Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data |
| I.S. CEN ISO TR 14969:2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| BS EN ISO 7197:2009 | Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| AAMI ISO 10651-5 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| 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) |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| ISO 19611:2017 | Traditional Chinese medicine — Air extraction cupping device |
| 13/30284773 DC : 0 | BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| 02/564513 DC : DRAFT OCT 2002 | BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
| BS PD ISO/TR 14969 : 2004 AMD 15958 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| 13/30284776 DC : 0 | BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
| 02/564516 DC : DRAFT OCT 2002 | BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| ISO 18242:2016 | Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps |
| AAMI ISO TIR 14969 : 2004 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| BS EN ISO 5840-1:2015 | Cardiovascular implants. Cardiac valve prostheses General requirements |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| CSA Z11138-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| 02/564517 DC : DRAFT OCT 2002 | BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 14/30257644 DC : 0 | BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| 03/101659 DC : DRAFT JAN 2003 | ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| UNE-EN ISO 5840-1:2016 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| 04/30088722 DC : DRAFT APR 2004 | ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: TERMINOLOGY |
| UNI EN ISO 17664 : 2005 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| ISO 18362:2016 | Manufacture of cell-based health care products Control of microbial risks during processing |
| I.S. EN ISO 1135-3:2017 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| UNI CEN ISO/TS 11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| ISO 15675:2016 | Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
| EN ISO 15378:2017 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017) |
| AAMI RD16 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
| BS EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| I.S. EN ISO 7197:2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| I.S. EN ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| DIN EN ISO 8536-9:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| ISO 1135-5:2015 | Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus |
| UNE-EN ISO 11140-1:2015 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| BS EN ISO 21649:2009 | Needle-free injectors for medical use. Requirements and test methods |
| ISO 7197:2006 | Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| BS EN ISO 1135-4:2015 | Transfusion equipment for medical use Transfusion sets for single use, gravity feed |
| ISO 22794:2007 | Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
| UNI EN ISO 5840 : 2009 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| UNE-EN ISO 5361:2017 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| CSA ISO 11607-1 : 2016 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| ISO 18746:2016 | Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use |
| AAMI ISO 11607-1 : 2006 : R2010 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| 15/30282343 DC : 0 | BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| CSA Z17664 : 2006 : R2011 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
| 04/30078099 DC : DRAFT JUL 2004 | ISO 11138-2 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: USE IN ASSESSING ETHYLENE OXIDE STERILIZATION PROCESSES |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| UNI EN ISO 21649 : 2009 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| 01/561789 DC : DRAFT APR 2001 | BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| ASTM F 2407 : 2006 : R2013 : EDT 1 | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| AAMI TIR16 : 2017 | MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| BS ISO 18362:2016 | Manufacture of cell-based health care products. Control of microbial risks during processing |
| 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 |
| 09/30180393 DC : 0 | BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| EN ISO 13408-2:2018 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| DIN EN ISO 1135-3 E : 2017 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| 17/30302489 DC : DRAFT MAR 2017 | BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
| 04/30081258 DC : DRAFT MARCH 2004 | BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS |
| BS ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
| BS EN ISO 15378:2017 | Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| DIN EN ISO 7198:2017-07 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| 11/30219211 DC : 0 | BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
| BS EN ISO 5361:2016 | Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
| 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 |
| 03/314215 DC : DRAFT OCT 2003 | ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| 14/30289934 DC : 0 | BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES |
| BS 7208-19(2001) : 2001 | CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 2: CONTACT LENS CARE PRODUCTS |
| UNI EN ISO 7197 : 2009 | NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
| BS EN ISO 18369-1:2017 | Ophthalmic optics. Contact lenses Vocabulary, classification system and recommendations for labelling specifications |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 02/565260 DC : DRAFT DEC 2002 | ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| CSA ISO TR 14969 : 2005 : R2015 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| AAMI ST81 :2004 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| 02/564518 DC : DRAFT OCT 2002 | BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR USE WITH PRESSURE INFUSION EQUIPMENT |
| AAMI ST81 : 2004 : R2010 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| CSA Z11140.1 : 2007 : R2012 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA Z11140.1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA ISO TR 14969 :2005 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| 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) |
| UNI EN ISO 11607-1 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| ISO 15674:2016 | Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| ISO 15676:2016 | Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) |
| ISO 10651-5:2006 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
| BS EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| UNE-EN ISO 1135-4:2016 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) |
| BS EN ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| 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 1135-3:2016 | Transfusion equipment for medical use Part 3: Blood-taking sets for single use |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
| UNE-EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
| 00/565497 DC : DRAFT DEC 2000 | BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN 13503-8:2000 | Ophthalmic implants. Intraocular lenses Fundamental requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO 8536-9:2015 | Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment |
| ISO 8536-11:2015 | Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment |
| BS EN ISO 5840:2009 | Cardiovascular implants. Cardiac valve prostheses |
| BS EN ISO 22794:2009 | Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
| 04/30106146 DC : DRAFT MARCH 2004 | BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 1135-3:2017 | Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) |
| EN ISO 21649:2009 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 5361:2016 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN ISO 22803:2005 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
| EN ISO 7197:2009 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
| EN ISO 11138-2:2017 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017) |
| 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 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
| EN ISO 1135-5:2015 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
| CSA Z17664 : 2006 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| CSA Z17664 : 2006 (R2016) | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
| BS ISO 11712:2009 | Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| BS EN 16372:2014 | Aesthetic surgery services |
| ASTM F 1441 : 2003 | Standard Specification for Soft-Tissue Expander Devices |
| BS EN ISO 1135-3:2017 | Transfusion equipment for medical use Blood-taking sets for single use |
| ISO 18369-1:2017 | Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications |
| DIN EN ISO 1135-3:2014-12 (Draft) | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| 15/30321505 DC : 0 | BS EN ISO 11138-2 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
| 04/30101211 DC : DRAFT APR 2004 | ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| AAMI ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| PD CEN ISO/TR 14969:2005 | Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
| 08/30179589 DC : DRAFT MAR 2008 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| CSA Z8637 : 2008 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| 16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
| CSA ISO 5840 : 0 | CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
| 15/30314236 DC : 0 | BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) |
| 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 |
| 04/19975667 DC : 0 | BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - SINGLE - USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANCE OXYGENATION |
| 05/30106198 DC : 0 | EN ISO 22442-3 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
| BS ISO 7197:1997 | Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
| 11/30227618 DC : 0 | BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
| CSA ISO TR 14969 : 2005 : R2010 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
| 05/30060678 DC : DRAFT SEP 2005 | BS EN ISO 22794 - DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| 03/113382 DC : DRAFT SEP 2003 | BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| ASTM F 2726 : 2008 | Standard specification for fixation devices for tracheal tubes and other airway devices |
| CSA Z11138-1 : 2007 : R2012 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| CSA Z11138-1 : 2007 : R2016 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| BS EN ISO 11607-1 : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| ONORM EN ISO 5840-1 : 2015 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| BS ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| ANSI/AAMI/ISO 18242:2016 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS |
| ISO/TR 14283:2018 | Implants for surgery Essential principles of safety and performance |
| ISO/TS 15539:2000 | Cardiovascular implants Endovascular prostheses |
| I.S. EN ISO 7199:2017 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| ASTM F 1441 : 2003 : R2009 | Standard Specification for Soft-Tissue Expander Devices |
| CSA ISO 11140-1 : 2016 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| ASTM F 1441 : 2003 : R2014 | Standard Specification for Soft-Tissue Expander Devices |
| EN ISO 17664:2017 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
| I.S. EN ISO 15378:2017 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| DIN EN ISO 11138-2:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| UNE-EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
| UNE-EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| BS EN ISO 8536-11:2015 | Infusion equipment for medical use Infusion filters for single use with pressure infusion equipment |
| ISO 22803:2004 | Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
| EN ISO 7199:2017 | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| BS EN ISO 8320-2:2001 | Contact lenses and contact lens care products. Vocabulary Contact lens care products |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| EN ISO 1135-4 : 2015 COR 2016 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| EN ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) |
| EN ISO 5840:2009 | Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| CSA Z10651-5 : 2008 : R2018 | Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
| CSA Z10651-5 : 2008 : R2013 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z10651-5 : 2008 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| CSA Z10651-5 : 2008 : INC : UPD 1 : 2011 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
| 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 |
| AS/NZS 4187:2014 | Reprocessing of reusable medical devices in health service organisations |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 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 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| AAMI TIR15 : 2016 | PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| 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/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| 1994/9/EC : 1994 | DIRECTIVE 94/9/EC OF THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 23 MARCH 1994 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES |
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