ANSI Z80.27 : 2014
|
OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
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 |
ISO/TS 20993:2006
|
Biological evaluation of medical devices Guidance on a risk-management process |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
ISO 25841:2017
|
Female condoms — Requirements and test methods |
UNE-EN ISO 22442-1:2016
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
CSA ISO 10993-7 : 1998
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ASTM F 3089 : 2014
|
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions |
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) |
DIN EN ISO 10993-12 E : 2012
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
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 10993-12:2012
|
Biological evaluation of medical devices Sample preparation and reference materials |
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 14534:2015
|
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
EN 12011 : 1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
UNI EN ISO 10993-12 : 2012
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
NBR ISO 10993-7 : 2005
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
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 |
AAMI ISO 10993-7:2008(R2012)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
ASTM F 2064 : 2017 : REDLINE
|
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
ISO/TR 10993-9:1994
|
Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing |
ONORM EN ISO 7405 : 2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD 1:2013) |
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 10993-12:2012-10
|
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
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 1441:1998
|
Medical devices. Risk analysis |
BS EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Application of risk management |
I.S. EN ISO 14534:2015
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
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 10993-12:2012
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
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 |
BS ISO 25841:2017
|
Female condoms. Requirements and test methods |
17/30343686 DC : 0
|
BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
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 |
AAMI ISO 10993-7 : 2008
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
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 |
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) |
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
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 10993-7:2009-02
|
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
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 |
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 10993-7:2008
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008) |
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) |
CSA ISO 10993-11 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY |
BS EN ISO 7405 : 2008
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
ONORM EN ISO 10993-7 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
UNI EN ISO 10993-7 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
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 |
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) |
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 |
DIN EN ISO 14534:2015-08
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
BS EN ISO 11979-5:2006
|
Ophthalmic implants. Intraocular lenses Biocompatibility |
BS EN ISO 10993-7:2008
|
Biological evaluation of medical devices Ethylene oxide sterilization residuals |
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 |
UNE-EN ISO 10993-12:2013
|
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
ISO 10993-12:2012
|
Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ISO 14534:2011
|
Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
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) |
UNE-EN ISO 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
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 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN 1441 : 1997
|
MEDICAL DEVICES - RISK ANALYSIS |
BS ISO 27427:2013
|
Anaesthetic and respiratory equipment. Nebulizing systems and components |
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 |
AAMI ISO 10993-1:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
EN ISO 10993-12:2012
|
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
ANSI/AAMI/ISO 10993-12:2012
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
UNI EN ISO 22794 : 2009
|
DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
EN ISO 7405:2008/A1:2013
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
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 |
EN 12442-1 : 2000
|
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
EN ISO 10993-7 : 2008 COR 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |