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  • ISO 10993-10:2010

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  16-11-2021

    Language(s):  English, French

    Published date:  27-07-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

    ISO 10993-10:2010 includes:

    • pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
    • details of in vivo (irritation and sensitization) test procedures;
    • key factors for the interpretation of the results.

    Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes ISO/DIS 10993-10. (07/2010)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ANSI Z80.27 : 2014 OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
    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)
    07/30169357 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
    DD ISO/TS 10993-20:2006 Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
    BS ISO 16840-2:2018 Wheelchair seating Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
    ASTM F 2407 : 2006 : R2013 : EDT 1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    16/30310940 DC : 0 BS EN ISO 5667-16 - WATER QUALITY - SAMPLING - PART 16: GUIDANCE ON BIOTESTING OF SAMPLES
    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
    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)
    DIN EN 14683:2014-07 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    BS ISO 18666:2015 Traditional Chinese medicine. General requirements of moxibustion devices
    15/30278540 DC : 0 BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE
    09/30195717 DC : 0 BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS
    06/30106186 DC : 0 ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM
    08/30133979 DC : DRAFT MAY 2008 BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
    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)
    CEN/TR 16953:2017 Medical gloves for single use - Guidance for selection
    17/30358658 DC : 0 BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    17/30358661 DC : 0 BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
    CSA ISO 10993-7 : 1998 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    UNI EN 14683 : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    ASTM F 3273 : 2017 Standard Specification for Wrought Molybdenum-47.5 Rhenium Alloy for Surgical Implants (UNS R03700)
    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)
    ASTM F 2147 : 2001 : R2016 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    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 10993-12 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 455-3:2015 Medical gloves for single use Requirements and testing for biological evaluation
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    BS EN ISO 9394:2012 Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes
    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
    VDI 5703:2015-09 Systematical development for a model-based testing of medical devices
    NBR ISO 8009 : 2009 MECHANICAL CONTRACEPTIVES - REUSABLE NATURAL AND SILICONE RUBBER CONTRACEPTIVE DIAPHRAGMS - REQUIREMENTS AND TESTS
    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
    08/30181526 DC : DRAFT MAY 2008 BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
    PREN 14683 : DRAFT 2017 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    PREN 13795-1 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
    ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    AAMI ISO 10993-7:2008(R2012) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    15/30321715 DC : 0 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    17/30344601 DC : 0 BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    ISO 20308:2017 Traditional Chinese medicine — Gua Sha instruments
    04/19976241 DC : DRAFT AUG 2004
    13/30281504 DC : 0 BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    06/30097290 DC : DRAFT FEB 2006 ISO 10993-7 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    15/30303073 DC : 0 BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS
    08/30179592 DC : DRAFT MAR 2008 BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
    AAMI TIR30 : 2011 A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
    ISO 18763:2016 Soil quality — Determination of the toxic effects of pollutants on germination and early growth of higher plants
    PD CEN/TR 16953:2017 Medical gloves for single use. Guidance for selection
    ASTM F 2407 : 2006 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    DIN EN 14683 E : 2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
    DIN EN ISO 3826-1:2013-09 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    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 4074:2016-05 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    DIN EN ISO 10993-12:2012-10 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    DIN EN ISO 9394:2013-01 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    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 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 9394:2012 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
    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 4074:2015 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    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)
    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)
    VDI 3823 Blatt 4:2006-11 Vacuum coating quality assurance - Testing of vacuum coated plastics
    15/30281262 DC : 0 BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
    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 17218:2014 Sterile acupuncture needles for single use
    ISO 29942:2011 Prophylactic dams — Requirements and test methods
    BS ISO 15675:2009 Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
    11/30243462 DC : 0 BS EN ISO 9394 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
    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
    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
    12/30251858 DC : 0 BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
    BS ISO 16038:2017 Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
    BS ISO 23409:2011 Male condoms. Requirements and test methods for condoms made from synthetic materials
    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
    ISO/TS 20993:2006 Biological evaluation of medical devices Guidance on a risk-management process
    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
    ANSI/AAMI/ISO TIR10993-20:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES
    AAMI TIR30:2011(R2016) A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
    ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
    ASTM F 2808 : 2017 : REDLINE Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin
    ASTM F 2147 : 2001 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
    ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
    ISO 16840-10:2014 Wheelchairs Resistance to ignition of non-integrated seat and back support cushions Part 10: Requirements and test methods
    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 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    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)
    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)
    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 9394 : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES
    S.R. CEN/TR 16953:2017 MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION
    UNI EN ISO 10993-1 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    BS ISO 8009:2014 Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    PREN 455-3 : DRAFT 2013 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    BS ISO 29942:2011 Prophylactic dams. Requirements and test methods
    01/563307 DC : DRAFT AUG 2001 BS ISO 15747 - PLASTICS CONTAINERS FOR INTRAVENOUS INJECTION
    BS ISO 20308:2017 Traditional Chinese medicine. Gua Sha instruments
    16/30319982 DC : 0 BS ISO 20308 - TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS
    CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    BS EN 14683:2014 Medical face masks. Requirements and test methods
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
    ISO 17218:2014 Sterile acupuncture needles for single use
    ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
    PREN ISO 3826-1 : DRAFT 2010 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
    I.S. EN ISO 7405:2009 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
    17/30359567 DC : 0 BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 7405:2013-12 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013)
    ASTM F 2147 : 2001 : R2010 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
    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
    ASTM F 2147 : 2001 : R2006 Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
    EN 14683:2014 Medical face masks - Requirements and test methods
    UNI EN ISO 7405 : 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
    ISO 18666:2015 Traditional Chinese medicine General requirements of moxibustion devices
    ISO 16840-2:2018 Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity
    ISO 8009:2014 Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
    I.S. EN 14683:2014 MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
    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
    DIN EN ISO 9394 E : 2013 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)
    ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
    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
    BS EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Conventional containers
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    UNE-EN ISO 4074:2016 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    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
    UNE-EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    UNE-EN ISO 9394:2013 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    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)
    I.S. EN 455-3:2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
    ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
    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 10993-8 : 2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    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 ISO 9394:2012 Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
    EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    15/30316155 DC : 0 BS ISO 16840-2 - WHEELCHAIR SEATING - PART 2: DETERMINATION OF PHYSICAL AND MECHANICAL CHARACTERISTICS OF DEVICES INTENDED TO MANAGE TISSUE INTEGRITY - SEAT CUSHIONS
    10/30233840 DC : 0 BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
    BS ISO 18763:2016 Soil quality. Determination of the toxic effects of pollutants on germination and early growth of higher plants
    PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
    BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
    07/30163763 DC : 0 BS ISO 7405 - DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS
    BS ISO 16840-10:2014 Wheelchairs. Resistance to ignition of non-integrated seat and back support cushions Requirements and test methods
    AAMI ISO 10993-1 : 2009 : R2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    CSA ISO 5840 : 0 CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES
    I.S. 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)
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    PREN 13795-2 : DRAFT 2017 SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
    ANSI/AAMI/ISO 10993-12:2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
    ASTM F 2848 : 2017 : REDLINE Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
    UNI EN ISO 22794 : 2009 DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
    ASTM F 720 : 2017 : REDLINE Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
    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
    ONORM EN ISO 3826-1 : 2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    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
    BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods
    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)
    ONORM EN 455-3 : 2015 MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 9394:2012 Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
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