DD ISO/TS 10993-20:2006
|
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices |
ANSI/AAMI/ISO 10993-3:2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
04/30103836 DC : DRAFT JUL 2004
|
ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
BS ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
AAMI ISO 10993-1 : 2009 : R2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
14/30295064 DC : 0
|
BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
ISO/TS 20993:2006
|
Biological evaluation of medical devices Guidance on a risk-management process |
00/561676 DC : DRAFT APRIL 2000
|
DRAFT BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
11/30212473 DC : 0
|
BS EN ISO 10993-3 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
ANSI Z80.12 : 2007 : R2017
|
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
ANSI Z80.13 : 2007 : R2012
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
UNE-EN ISO 22442-1:2016
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
ISO 7405:2008
|
Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
DIN EN ISO 11979-5:2010-11
|
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
DIN EN ISO 22442-1:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
BS EN ISO 10993-1 : 2009-10
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
BS EN ISO 22803:2005
|
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
UNE-EN ISO 16672:2016
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN ISO 10993-3:2014
|
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity |
EN 12011 : 1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
ONORM EN ISO 11979-5 : 2010
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
ONORM EN ISO 10993-1 : 2011
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
14/30295067 DC : 0
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
ANSI Z80.13 : 2007
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
ISO/TR 10993-9:1994
|
Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing |
ASTM F 3273 : 2017
|
Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700) |
ASTM F 3207 : 2017
|
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
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) |
DIN EN ISO 16672:2015-12
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
EN ISO 10993-1:2009/AC:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010) |
BS EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Application of risk management |
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 22442-1:2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
I.S. EN ISO 10993-3:2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
I.S. EN ISO 16672:2015
|
OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
OVE/ONORM EN 60601-1 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
I.S. EN 12442-1:2000
|
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
17/30343686 DC : 0
|
BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
BS ISO 27427:2013
|
Anaesthetic and respiratory equipment. Nebulizing systems and components |
ANSI Z80.29 : 2015
|
OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES |
08/30178723 DC : DRAFT AUG 2008
|
BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
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 |
ANSI/AAMI/ISO 22442-1:2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
EN ISO 16671:2015/A1:2017
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
ANSI/AAMI/ISO TIR10993-20:2006
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
ISO/TR 37137:2014
|
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
I.S. EN ISO 16671:2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
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) |
DIN EN ISO 10993-3:2015-02
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY (ISO 10993-3:2014) |
DIN EN ISO 10993-1:2010-04
|
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
DIN EN ISO 11979-5 E : 2010
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
UNE-EN ISO 10993-3:2015
|
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
ISO 10993-3:2014
|
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 22794:2007
|
Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
I.S. EN ISO 11979-5:2006
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
EN ISO 11979-5:2006
|
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
ONORM EN ISO 15798 : 2013 AMD 1 2018
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
UNI EN ISO 10993-3 : 2015
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
BS EN ISO 7405 : 2008
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
UNI EN ISO 10993-1 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
I.S. EN 12011:1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
02/560790 DC : DRAFT FEB 2002
|
BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
08/30170164 DC : DRAFT AUG 2008
|
BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
ANSI Z80.13 : 2007 : R2017
|
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
I.S. EN ISO 15798:2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
AAMI BE78 : 2002
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
I.S. EN ISO 7405:2009
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
ISO 16671:2015
|
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
DIN EN ISO 7405:2013-12
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
ASTM F 2695 : 2012 : REDLINE
|
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
UNI EN ISO 7405 : 2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
BS EN ISO 16671 : 2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
ISO/TS 10993-20:2006
|
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
BS EN ISO 11979-5:2006
|
Ophthalmic implants. Intraocular lenses Biocompatibility |
BS EN 12011:1998
|
Instrumentation to be used in association with non-active surgical implants. General requirements |
ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
ISO 16672:2015
|
Ophthalmic implants Ocular endotamponades |
ISO 11979-5:2006
|
Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
I.S. EN ISO 10993-1:2009+AC:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
BS EN ISO 22794:2009
|
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file |
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 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 10993-3:2014
|
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
08/30156451 DC : DRAFT AUG 2008
|
BS EN ISO 10993-13 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
PD ISO/TR 37137:2014
|
Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
07/30163763 DC : 0
|
BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
CSA ISO 5840 : 0
|
CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
ANSI Z80.30 : 2010
|
OPHTHALMICS - TORIC INTRAOCULAR LENSES |
AAMI ISO 10993-1:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
ANSI Z80.12 : 2007
|
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES |
UNE-EN ISO 16671:2016
|
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
ISO/TS 22911:2016
|
Dentistry Preclinical evaluation of dental implant systems Animal test methods |
EN ISO 15798:2013/A1:2017
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
UNI EN ISO 22794 : 2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ISO 15798:2013
|
Ophthalmic implants Ophthalmic viscosurgical devices |
EN ISO 7405:2008/A1:2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
ONORM EN ISO 7405 : 2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013) |
NF EN ISO 10993-1 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
ISO 22803:2004
|
Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
BS EN ISO 16672:2015
|
Ophthalmic implants. Ocular endotamponades |
EN 12442-1 : 2000
|
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |