BS ISO 17966:2016
|
Assistive products for personal hygiene that support users. Requirements and test methods |
14/30270462 DC : 0
|
BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
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 |
ASTM F 3225 : 2017
|
Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
17/30351468 DC : 0
|
BS EN ISO 16671:2015 AMD 1 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
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 11135:2014-10
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
DD ISO/TS 10993-19:2006
|
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials |
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 |
AAMI/ISO TIR22442-4:2011(R2016)
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 4: PRINCIPLES FOR ELIMINATION AND/OR INACTIVATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS AND VALIDATION ASSAYS FOR THOSE PROCESSES |
CSA ISO 14937 : 2011
|
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 |
ANSI/AAMI/ISO 14937:2009(R2013)
|
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 |
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) |
ONORM EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
ANSI/AAMI/ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
ANSI/AAMI/ISO 11135:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 13485 - PRACTICAL GUIDE : 2016
|
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
CSA Z17665-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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 |
ASTM F 3089 : 2014
|
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
DIN EN 1642:2012-06
|
Dentistry - Medical devices for dentistry - Dental implants |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling |
BS EN ISO 14160:2011
|
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 14630:2012
|
Non-active surgical implants. General requirements |
UNI EN ISO 14160 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS EN ISO 20857:2013
|
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices |
PD ISO/TR 22442-4:2010
|
Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes |
DIN ISO 13022 E : 2014
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
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) |
14/30295067 DC : 0
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
17/30323851 DC : 0
|
BS ISO 19894 - WALKING TROLLEYS - REQUIREMENTS AND TEST METHODS |
ISO/TR 22442-4:2010
|
Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes |
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 5910:2018
|
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices |
ANSI/AAMI/ISO 14160:2011(R2016)
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNI EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
ISO/TS 19930:2017
|
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
I.S. EN ISO 5840-1:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
UNI EN ISO 11135 : 2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 22442-2:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
EN 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 14937:2009) |
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 12182:2012-07
|
Assistive products for persons with disability - General requirements and test methods |
I.S. EN ISO 22794:2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
I.S. EN 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 |
I.S. EN 12182:2012
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 14160:2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
I.S. EN ISO 22442-2:2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015) |
I.S. EN 1642:2011
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
EN ISO 5840-1:2015
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
EN ISO 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
EN ISO 5840-3:2013
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
I.S. EN ISO 14630:2012
|
NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
UNI EN 1642 : 2012
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
I.S. EN ISO 17665-1:2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE-EN ISO 11135:2015
|
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
ANSI/AAMI/ISO TIR10993-19:2006
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS |
BS EN ISO 5840-1:2015
|
Cardiovascular implants. Cardiac valve prostheses General requirements |
BS EN ISO 11135:2014
|
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 5840-3:2013
|
Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
08/30178723 DC : DRAFT AUG 2008
|
BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
CSA Z11135-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE-EN ISO 5840-1:2016
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
DIN ISO 13022:2014-06
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
DIN EN ISO 5840-1:2015-12
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
EN ISO 16671:2015/A1:2017
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
AAMI 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 |
ANSI/AAMI ISO 17665-1:2006(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 5840-1 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
CSA Z17665-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 11135-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ASTM F 2903 : 2011
|
Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
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 |
I.S. EN ISO 16671:2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
DIN EN ISO 22523:2007-04
|
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
DIN EN ISO 22794:2009-11
|
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
UNE-EN ISO 14160:2012
|
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
UNI EN 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 |
UNI EN 12182 : 2012
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
UNI EN ISO 14630 : 2013
|
NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
DIN EN ISO 20857 E : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
PREN ISO 14160 : DRAFT 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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 |
I.S. EN ISO 11135-1:2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE-EN ISO 20857:2013
|
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
14/30257546 DC : 0
|
BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS |
09/30157765 DC : 0
|
BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 17665-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11135-1 :2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
EN ISO 14160:2011
|
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
ANSI/AAMI/ISO 20857:2010(R2015)
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO TIR 22442-4:2011
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 4: PRINCIPLES FOR ELIMINATION AND/OR INACTIVATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS AND VALIDATION ASSAYS FOR THOSE PROCESSES |
UNI EN ISO 20857 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11135-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE-EN ISO 22442-2:2016
|
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
DIN EN ISO 20857:2013-08
|
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
I.S. EN ISO 15798:2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
I.S. EN ISO 11135:2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
AAMI ISO 14160 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
PD ISO/TS 19930:2017
|
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
ISO 16671:2015
|
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
ISO 17966:2016
|
Assistive products for personal hygiene that support users Requirements and test methods |
BS EN ISO 16671 : 2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
ISO 13022:2012
|
Medical products containing viable human cells — Application of risk management and requirements for processing practices |
ISO/TS 10993-19:2006
|
Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
DIN EN ISO 14160:2011-10
|
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
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 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
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 |
BS EN ISO 17665-1:2006
|
Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
BS EN 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 5840-3:2013
|
Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
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) |
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
UNE-EN 1642:2012
|
Dentistry - Medical devices for dentistry - Dental implants |
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 |
UNE-EN ISO 14937:2010
|
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 14937:2009) |
UNE-EN ISO 14630:2013
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
ISO 14160:2011
|
Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 22794:2009
|
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
BS EN 12182:2012
|
Assistive products for persons with disability. General requirements and test methods |
ISO 22794:2007
|
Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
EN ISO 11135-1:2007
|
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
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 1642:2011
|
Dentistry - Medical devices for dentistry - Dental implants |
EN ISO 20857:2013
|
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
EN ISO 22794:2009
|
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
EN ISO 17665-1 : 2006
|
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
EN ISO 14630:2012
|
Non-active surgical implants - General requirements (ISO 14630:2012) |
DIN EN ISO 5840-1 E : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015) |
ANSI/AAMI/ISO 22442-2:2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
UNE-EN ISO 5840-3:2013
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
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) |
16/30310949 DC : 0
|
BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
14/30281560 DC : 0
|
BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
CSA Z11135 : 2015
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 20857 : 2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA ISO 14937 : 2011 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
EN ISO 11135:2014
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
ANSI/AAMI/ISO 13022:2012
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MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
UNE-EN ISO 16671:2016
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Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
CSA Z17665-1:09 (R2019)
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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
I.S. EN ISO 20857:2013
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STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
EN ISO 15798:2013/A1:2017
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OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
UNI EN ISO 22794 : 2009
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DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ISO 15798:2013
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Ophthalmic implants Ophthalmic viscosurgical devices |
ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
DIN EN ISO 11137-1:2015-11
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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) |
BS EN ISO 11135-1:2007
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Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 5840-1:2015
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Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
BS EN 1642:2011
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Dentistry. Medical devices for dentistry. Dental implants |
ISO 14630:2012
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Non-active surgical implants General requirements |
ISO 20857:2010
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Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
EN 12182:2012
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Assistive products for persons with disability - General requirements and test methods |
EN ISO 22442-3:2007
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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) |
DIN EN ISO 14937:2010-03
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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 14937:2009) |