ONORM EN ISO 10993-11 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
DIN EN ISO 29701:2011-01
|
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) |
ISO/TS 20787:2017
|
Nanotechnologies - Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii |
DIN EN ISO 3826-4 E : 2015
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
ANSI/AAMI/ISO 10993-3:2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY |
07/30160957 DC : 0
|
EN ISO 10993-5 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
04/30103836 DC : DRAFT JUL 2004
|
ISO 11979-5 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
AAMI ISO 10993-11 : 2006 : R2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
BS ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
AAMI ISO 10993-7:2008(R2012)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
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 |
08/30187781 DC : DRAFT AUG 2008
|
BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
ASTM F 2459 : 2018 : REDLINE
|
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
15/30278540 DC : 0
|
BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
16/30282706 DC : 0
|
BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
CSA ISO 10993-4 : 1997
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
ISO 19227:2018
|
Implants for surgery — Cleanliness of orthopedic implants — General requirements |
BS EN ISO 10993-16:2017
|
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables |
AAMI ISO 13408-2 : 2003
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
ANSI/AAMI/ISO 10993-14:2001(R2011)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
AAMI ISO 10993-5 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
ISO/TR 15499:2016
|
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
UNE-EN ISO 22442-1:2016
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
I.S. EN ISO 10993-11:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006) |
I.S. EN ISO 10993-16:2017
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010) |
UNE-EN ISO 5667-16:2017
|
Water quality - Sampling - Part 16: Guidance on biotesting of samples (ISO 5667-16:2017) |
ISO 7405:2008
|
Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
ISO 10993-4:2017
|
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
ISO 13408-2:2018
|
Aseptic processing of health care products — Part 2: Sterilizing filtration |
I.S. EN ISO 3826-1:2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
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 10993-10 E : 2003
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
DIN EN ISO 10993-11 E : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
DIN EN ISO 10993-15 E : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
DIN EN ISO 10993-13 E : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
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 10993-6:2017
|
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
BS EN ISO 14534:2015
|
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
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 |
VDI 5703:2015-09
|
Systematical development for a model-based testing of medical devices |
ONORM EN ISO 10993-10 : 2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
BS EN ISO 5667-16:2017
|
Water quality. Sampling Guidance on biotesting of samples |
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 |
DIN EN ISO 3826-4:2015-12
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
UNE-EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
AAMI/ISO TIR15499:2017
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
EN ISO 5667-16:2017
|
Water quality - Sampling - Part 16: Guidance on biotesting of samples (ISO 5667-16:2017) |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
I.S. EN ISO 13408-2:2018
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
AAMI ISO 10993-16 : 2010 : R2014
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
06/30097290 DC : DRAFT FEB 2006
|
ISO 10993-7 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ASTM F 3293 : 2018
|
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
15/30290736 DC : 0
|
BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
DIN EN ISO 16061:2015-09
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
BS EN ISO 10993-11:2009
|
Biological evaluation of medical devices Tests for systemic toxicity |
ISO/TR 10993-9:1994
|
Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing |
AAMI ISO 13408-2 : 2003 : R2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
CSA ISO 10993-13 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
UNI EN ISO 29701 : 2010
|
NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
ASTM F 2027 : 2016 : REDLINE
|
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
UNI EN ISO 10993-11 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
DIN EN ISO 3826-1:2013-09
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
UNI EN ISO 3826-1 : 2013
|
PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
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 11979-6 E : 2015
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014) |
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 10993-15:2009
|
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys |
BS EN ISO 10993-5:2009
|
Biological evaluation of medical devices Tests for in vitro cytotoxicity |
BS EN ISO 10993-6:2016
|
Biological evaluation of medical devices Tests for local effects after implantation |
UNE-EN ISO 10993-10:2013
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
BS EN ISO 22442-1:2015
|
Medical devices utilizing animal tissues and their derivatives Application of risk management |
I.S. EN ISO 10993-6:2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
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 10993-5:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:2009) |
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 10993-8:2000
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS |
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 10993-10:2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
I.S. EN ISO 11979-6:2014
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014) |
I.S. EN ISO 10993-13:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010) |
I.S. EN ISO 10993-14:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS (ISO 10993-14:2001) |
UNI EN ISO 11979-6 : 2015
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING |
NASA-STD-8719.27:2022
|
IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
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) |
ISO 10993-16:2017
|
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
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 |
13/30285624 DC : 0
|
BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
BS ISO 11350:2012
|
Water quality. Determination of the genotoxicity of water and waste water. Salmonella/microsome fluctuation test (Ames fluctuation test) |
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 |
AAMI ISO 10993-1:2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
CSA ISO 10993-5 : 0
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
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 10993-10 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
ANSI/AAMI/ISO 10993-6:2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
AAMI ISO 10993-7 : 2008
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
AAMI ISO 10993-14 : 2001
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
AAMI ISO 10993-15 : 2000 : R2011
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
EN ISO 10993-11:2009
|
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
I.S. EN ISO 7405:2009
|
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
PD ISO/TS 20787:2017
|
Nanotechnologies. Aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. Nauplii |
I.S. EN ISO 5667-16:2017
|
WATER QUALITY - SAMPLING - PART 16: GUIDANCE ON BIOTESTING OF SAMPLES (ISO 5667-16:2017) |
ISO 18562-4:2017
|
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
PREN ISO 11979-6 : DRAFT 2013
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013) |
EN ISO 10993-4:2017
|
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
ISO 11350:2012
|
Water quality — Determination of the genotoxicity of water and waste water — Salmonella/microsome fluctuation test (Ames fluctuation test) |
ISO 5667-16:2017
|
Water quality — Sampling — Part 16: Guidance on biotesting of samples |
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 10993-3:2015-02
|
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 |
DIN EN ISO 11979-6:2015-02
|
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
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 |
BS EN ISO 10993-8:2001
|
Biological evaluation of medical devices Selection and qualification of reference materials for biological tests |
BS EN ISO 10993-10:2013
|
Biological evaluation of medical devices Tests for irritation and skin sensitization |
DIN EN ISO 10993-10:2014-10
|
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
ISO 22794:2007
|
Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
DIN EN ISO 10993-15:2009-10
|
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
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) |
EN ISO 29701 : 2010
|
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) |
EN ISO 3826-4:2015
|
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
UNI EN ISO 10993-10 : 2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
UNI EN ISO 10993-3 : 2015
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
UNI EN ISO 10993-15 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
UNI EN ISO 10993-14 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
UNI EN ISO 10993-13 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
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 10993-5 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
13/30254047 DC : 0
|
BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
UNI EN ISO 10993-1 : 2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
I.S. EN ISO 29701:2010
|
NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
I.S. EN 12011:1998
|
INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
BS EN ISO 29701:2010
|
Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test |
EN ISO 13408-2:2018
|
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
PD ISO/TR 15499:2016
|
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process |
17/30302489 DC : DRAFT MAR 2017
|
BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
14/30261590 DC : 0
|
BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION |
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/TS 18827:2017
|
Nanotechnologies. Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials |
08/30170164 DC : DRAFT AUG 2008
|
BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
BS EN ISO 10993-4:2017
|
Biological evaluation of medical devices Selection of tests for interactions with blood |
09/30175345 DC : 0
|
BS ISO 29701 - NANOTECHNOLOGIES - ENDOTOXIN TEST ON NANOMATERIAL SAMPLES FOR IN VITRO SYSTEMS - LIMULUS AMEBOCYTE LYSATE (LAL) TEST |
AAMI ISO 10993-13:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
ANSI/AAMI/ISO 10993-5:2009(R2014)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
AAMI ISO 10993-16:2010
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
17/30302216 DC : 0
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BS ISO 19040-3 - WATER QUALITY - DETERMINATION OF THE ESTROGENIC POTENTIAL OF WATER AND WASTE WATER - PART 3: IN VITRO HUMAN CELL-BASED REPORTER GENE ASSAY |
AAMI BE78 : 2002
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
I.S. EN ISO 25539-1:2017
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CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
ISO/TR 37137:2014
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Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
PREN ISO 3826-1 : DRAFT 2010
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
DIN EN ISO 7405:2013-12
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
ASTM F 2695 : 2012 : REDLINE
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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
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
I.S. EN ISO 16061:2015
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INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
DIN EN ISO 14534:2015-08
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
DIN EN ISO 10993-5:2009-10
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
BS EN ISO 10993-14:2009
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Biological evaluation of medical devices Identification and quantification of degradation products from ceramics |
BS EN ISO 11979-5:2006
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Ophthalmic implants. Intraocular lenses Biocompatibility |
ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
ISO 10993-8:2000
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Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests |
ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements |
ISO 3826-1:2013
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Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
BS EN ISO 10993-7:2008
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Biological evaluation of medical devices Ethylene oxide sterilization residuals |
BS EN 12011:1998
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Instrumentation to be used in association with non-active surgical implants. General requirements |
BS EN ISO 3826-1:2013
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Plastics collapsible containers for human blood and blood components Conventional containers |
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
BS EN ISO 11979-6:2014
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Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing |
ISO 11979-6:2014
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Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
UNE-EN ISO 3826-1:2013
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Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
ISO 14534:2011
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Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
UNE-EN ISO 14534:2015
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
DIN EN ISO 10993-13:2010-11
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
ISO 11979-5:2006
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Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
I.S. EN ISO 10993-1:2009+AC:2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
AAMI ISO 10993-4 : 2002
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
BS EN 30993-4:1994
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Biological evaluation of medical devices Selection of tests for interactions with blood |
UNE-EN ISO 11979-6:2015
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
ISO 10993-5:2009
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Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
BS EN ISO 10993-13:2010
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Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices |
BS 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 |
UNE-EN ISO 10993-13:2010
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
I.S. EN ISO 10993-15:2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000) |
EN ISO 10993-6:2016
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
EN ISO 10993-10:2013
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Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
EN ISO 10993-15:2009
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
EN ISO 22803:2005
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Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
EN ISO 11979-6:2014
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
EN ISO 10993-8 : 2000
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS |
EN ISO 10993-5:2009
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
EN ISO 10993-14:2009
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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
EN 30993-4 : 1993
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
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 22794:2007, corrected version 2009-01-15) |
EN ISO 10993-3:2014
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
EN ISO 14534:2015
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN ISO 10993-13:2010
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
EN ISO 3826-1:2013
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Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
BS EN ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants. General requirements |
10/30233840 DC : 0
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BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
ANSI/AAMI/ISO 10993-10:2010(R2014)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION |
AAMI ISO 10993-15 : 2000
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
16/30335531 DC : 0
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BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES |
16/30312836 DC : 0
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BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS |
PD ISO/TR 37137:2014
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Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
BS EN ISO 3826-4:2015
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Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
07/30163763 DC : 0
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BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS |
AAMI ISO 10993-1 : 2009 : R2013
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
CSA ISO 5840 : 0
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CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
07/30162839 DC : 0
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BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
I.S. EN ISO 3826-4:2015
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
DIN EN ISO 10993-11:2015-12 (Draft)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
EN ISO 10993-16:2017
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017) |
UNE-EN ISO 10993-4:2018
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
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 |
EN ISO 7405:2008/A1:2013
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008) |
NF EN ISO 10993-1 : 2010
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
I.S. EN ISO 10993-4:2017
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017) |
ISO 27427:2013
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Anaesthetic and respiratory equipment — Nebulizing systems and components |
ONORM EN ISO 3826-1 : 2013
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PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
DIN EN ISO 10993-6:2009-08
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
ISO 10993-6:2016
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Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
ISO 22803:2004
|
Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
ISO 3826-4:2015
|
Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
ISO 29701:2010
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Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test |
EN ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
DIN EN ISO 10993-11:2009-08
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
DIN EN ISO 10993-6:2017-09
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
EN ISO 10993-7 : 2008 COR 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
DIN EN ISO 10993-10:2003-02
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |