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  • ISO/TS 10993-19:2006

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 19: Physico-chemical, morphological and topographical characterization of materials

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

    Withdrawn date:  18-03-2020

    Language(s):  English

    Published date:  19-05-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TS 10993-19:2006 provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

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

    Document Type Technical Specification
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    BS ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate
    ISO/TS 20993:2006 Biological evaluation of medical devices Guidance on a risk-management process
    AAMI ISO 10993-1 : 2009 : R2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    BS ISO 18666:2015 Traditional Chinese medicine. General requirements of moxibustion devices
    06/30106186 DC : 0 ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM
    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)
    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)
    ONORM EN ISO 10993-1 : 2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    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
    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
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    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 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    17/30343686 DC : 0 BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
    17/30319534 DC : 0 BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
    AAMI ISO 10993-1:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    ISO 13019:2018 Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
    ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
    ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
    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)
    UNI EN ISO 10993-1 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    15/30281262 DC : 0 BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES
    PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
    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
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
    ASTM F 3160 : 2016 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
    ISO 18666:2015 Traditional Chinese medicine General requirements of moxibustion devices
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    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 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
    10/30203224 DC : 0 BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
    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
    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
    EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

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

    ASTM F 1877 : 2016 : REDLINE Standard Practice for Characterization of Particles
    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    ASTM D 1894 : 2014 : REDLINE Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
    ISO 12179:2000 Geometrical Product Specifications (GPS) Surface texture: Profile method Calibration of contact (stylus) instruments
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    ISO 18754:2013 Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity
    EN 725-5:2007/AC:2007 ADVANCED TECHNICAL CERAMICS - METHODS OF TEST FOR CERAMIC POWDERS - PART 5: DETERMINATION OF PARTICLE SIZE DISTRIBUTION
    ASTM F 735 : 2017 : REDLINE Standard Test Method for Abrasion Resistance of Transparent Plastics and Coatings Using the Oscillating Sand Method
    ISO 13565-3:1998 Geometrical Product Specifications (GPS) Surface texture: Profile method; Surfaces having stratified functional properties Part 3: Height characterization using the material probability curve
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    EN 623-4:2004 Advanced technical ceramics - Monolithic ceramics - General and textural properties - Part 4: Determination of surface roughness
    ISO 17190-5:2001 Urine-absorbing aids for incontinence Test methods for characterizing polymer-based absorbent materials Part 5: Gravimetric determination of free swell capacity in saline solution
    ISO/TS 13762:2001 Particle size analysis Small angle X-ray scattering method
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ASTM F 732 : 2017 : REDLINE Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 17853:2011 Wear of implant materials Polymer and metal wear particles Isolation and characterization
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ASTM D 1044 : 2013 : REDLINE Standard Test Method for Resistance of Transparent Plastics to Surface Abrasion
    ISO 5436-2:2012 Geometrical product specifications (GPS) — Surface texture: Profile method; Measurement standards — Part 2: Software measurement standards
    ISO 13319:2007 Determination of particle size distributions Electrical sensing zone method
    ISO 3274:1996 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Nominal characteristics of contact (stylus) instruments
    ISO 18757:2003 Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of specific surface area of ceramic powders by gas adsorption using the BET method
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 5436-1:2000 Geometrical Product Specifications (GPS) — Surface texture: Profile method; Measurement standards — Part 1: Material measures
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 828:2013 Adhesives - Wettability - Determination by measurement of contact angle and surface free energy of solid surface
    ISO 13320-1:1999 Particle size analysis Laser diffraction methods Part 1: General principles
    ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
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