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  • ANSI/AAMI/ISO TIR10993-19:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-02-2024

    Language(s):  English

    Published date:  30-01-2006

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO/TS 10993-19:2006
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Symbols and abbreviated terms
    5 General principles
    6 Characterization procedure
      6.1 General
      6.2 Qualitative information
      6.3 Material equivalence
      6.4 Quantitative information
      6.5 Quantitative assessment
    7 Characterization parameters and methods
    8 Reporting of data obtained
    Annex A (informative) Principles for judging material
            equivalency
    Annex B (informative) Nanoparticles - Special consideration
            in judging material equivalency and biological
            evaluation
    Bibliography

    Abstract - (Show below) - (Hide below)

    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.

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

    Committee WG 14
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
    AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

    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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