UNE-EN ISO 25539-2:2013
|
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
AAMI SW87 : 2012
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APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS |
PD ISO/TR 27809:2007
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Health informatics. Measures for ensuring patient safety of health software |
UNE-EN ISO 25539-3:2012
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Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
16/30346073 DC : 0
|
BS ISO 16142-2 - 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 |
ANSI/AAMI/ISO 25539-2:2012
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CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
AAMI ISO TIR 16142 : 2005
|
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
AAMI ISO 13408-1 : 2008 : R2011
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
CSA ISO 14971 : 2007
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
I.S. EN ISO 14607:2009
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NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018) |
AAMI ISO TIR 17665-3:2014
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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 |
ISO 16142-1:2016
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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
AAMI/ISO TIR17665-3:2014(R2016)
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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 |
ISO 14607:2007
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Non-active surgical implants Mammary implants Particular requirements |
BS EN ISO 14534:2015
|
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
ISO 25539-3:2011
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Cardiovascular implants Endovascular devices Part 3: Vena cava filters |
ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements |
EN ISO 25539-3:2011
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Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
EN ISO 80601-2-13:2012
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Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
UNE-EN ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
ISO/TR 27809:2007
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Health informatics Measures for ensuring patient safety of health software |
CSA Z17665-2:09 (R2019)
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Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15) |
ISO 17593:2007
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Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
DIN EN ISO 13408-1:2015-12
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
DIN EN ISO 25539-3:2012-03
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Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
PD ISO/TR 16142:2006
|
Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
DIN EN ISO 16061:2015-09
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
UNI CEN ISO/TS 17665-2 : 2009
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STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
BS EN ISO 13408-1:2015
|
Aseptic processing of health care products General requirements |
ISO 18362:2016
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Manufacture of cell-based health care products Control of microbial risks during processing |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
I.S. EN ISO 14971:2012
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
UNE-EN ISO 80601-2-13:2013
|
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
I.S. EN ISO 14534:2015
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
10/30196945 DC : 0
|
BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
13/30285624 DC : 0
|
BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
ISO/TR 16142:2006
|
Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
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 |
BS ISO 27427:2013
|
Anaesthetic and respiratory equipment. Nebulizing systems and components |
BS ISO 16142-1:2016
|
Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
14/30257644 DC : 0
|
BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
07/30090385 DC : 0
|
ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
CSA Z17665-2:09 (R2019)
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
AAMI ISO 25539-3 : 2011
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
AAMI TIR48 : 2015
|
QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS |
I.S. EN ISO 25539-3:2011
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
CEN/TR 15640:2007
|
Health informatics - Measures for ensuring the patient safety of health software |
I.S. EN ISO 80601-2-13:2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
UNI EN ISO 25539-3 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
EN ISO 25539-2:2012
|
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
I.S. EN ISO 25539-2:2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
BS EN ISO 80601-2-13:2012
|
Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI ISO TIR 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
PD CEN/TR 15640:2007
|
Health informatics. Measures for ensuring the patient safety of health software |
BS EN ISO 25539-2:2012
|
Cardiovascular implants. Endovascular devices Vascular stents |
12/30244415 DC : DRAFT APR 2012
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
CSA ISO 14971 : 2007 : R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
UNI EN ISO 25539-2 : 2013
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
DIN EN ISO 25539-2:2013-05
|
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
AAMI ISO 13408-1:2008
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI/ISO TIR17665-2:2009(R2016)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
EN ISO 14607:2018
|
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08) |
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) |
I.S. EN ISO 16061:2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
DIN EN ISO 14534:2015-08
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants General requirements |
ISO 25539-2:2012
|
Cardiovascular implants Endovascular devices Part 2: Vascular stents |
ISO 14534:2011
|
Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
UNE-EN ISO 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
ISO 80601-2-13:2011
|
Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
UNI EN ISO 80601-2-13 : 2013
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
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 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
BS EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants. General requirements |
S.R. CEN TR 15640:2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
BS ISO 18362:2016
|
Manufacture of cell-based health care products. Control of microbial risks during processing |
BS ISO 17593:2007
|
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
BS EN ISO 25539-3:2011
|
Cardiovascular implants. Endovascular devices Vena cava filters |
DD CEN ISO/TS 17665-2:2009
|
Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
CSA Z17665-2 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
S.R. CEN ISO/TS 17665-2:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
CSA ISO 14971 : 2007 : R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
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 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
BS EN ISO 80601-2-13:2012+A2:2019
|
Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
ISO/TS 17665-2:2009
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
CEN ISO/TS 17665-2:2009
|
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |