I.S. EN ISO 5840:2009
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CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
02/563845 DC : DRAFT SEP 2002
|
BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
CSA ISO 14971 : 2007
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
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 |
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 |
CSA Z17665-1 : 2009 : FR
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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 |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
ASTM F 2347 : 2015 : REDLINE
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Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
BS EN 13641:2002
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Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
EN 12442-3 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
EN 12442-2 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
I.S. EN 12442-3:2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
PD ISO/TS 17665-3:2013
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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 |
04/30048205 DC : DRAFT JUL 2004
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BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
03/103026 DC : DRAFT JAN 2003
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BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
AAMI ISO 5840 : 2005 : R2010
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CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
AAMI ISO 5840 :2005
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CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
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 |
AAMI BE83 : 2006
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
CEI UNI EN ISO 14971 : 2013
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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 17665-1:2006-11
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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 (ISO 17665-1:2006) |
DIN EN ISO 10993-18:2009-08
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
UNI EN ISO 10993-18 : 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
04/30048118 DC : DRAFT MAY 2004
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BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
I.S. EN 12442-2:2000
|
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
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 |
04/300654 DC : DRAFT JAN 2004
|
BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
03/317861 DC : DRAFT OCT 2003
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EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
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) |
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 |
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 |
ASTM F 2103 : 2011-03
|
GUIDE FOR CHARACTERIZATION AND TESTING OF CHITOSAN SALTS AS STARTING MATERIALS INTENDED FOR USE IN BIOMEDICAL AND TISSUE-ENGINEERED MEDICAL PRODUCT APPLICATIONS |
ASTM F 2212 : 2011 : REDLINE
|
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
ISO 10993-18:2005
|
Biological evaluation of medical devices Part 18: Chemical characterization of materials |
BS EN ISO 10993-18:2009
|
Biological evaluation of medical devices Chemical characterization of materials |
ISO 5840:2005
|
Cardiovascular implants Cardiac valve prostheses |
BS EN 12442-2:2000
|
Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling |
I.S. EN ISO 10993-18:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) |
EN ISO 10993-18:2009
|
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
UNI EN ISO 5840 : 2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
UNI CEN/TS 15277 : 2007
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
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 |
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 |
BS EN 12442-3:2000
|
Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
BS EN ISO 5840:2009
|
Cardiovascular implants. Cardiac valve prostheses |
EN 13641:2002
|
Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
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) |
03/100426 DC : DRAFT JAN 2003
|
BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
ANSI/AAMI BE83:2006(R2011)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
04/30048301 DC : DRAFT MAY 2004
|
BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA ISO 14971 : 2007 : R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 14971 : 2007 : R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
I.S. CEN TS 15277:2006
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
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 |
DIN EN ISO 10993-18 E : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
DIN EN ISO 5840:2009-08
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
CEN/TS 15277:2006
|
Non-active surgical implants - Injectable implants |
EN ISO 5840:2009
|
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |