Skip to content
Please enter a keyword to search

  • ISO 10993-14:2001

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

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

    Language(s):  English, French

    Published date:  22-11-2001

    Publisher:  International Organization for Standardization

    Add To Cart

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

    Committee ISO/TC 194
    Development Note Supersedes ISO/FDIS 10993-14 (11/2001)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current

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

    BS ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Evaluation and testing within a risk management process
    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
    03/100426 DC : DRAFT JAN 2003 BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
    06/30106186 DC : 0 ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    UNE-EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    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 10993-15 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    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)
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
    ONORM EN ISO 10993-10 : 2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    EN ISO 6872:2015/A1:2018 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015/AMD 1:2018)
    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)
    BS ISO 6474-1:2010 Implants for surgery. Ceramic materials Ceramic materials based on high purity alumina
    17/30344601 DC : 0 BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    AAMI/ISO TIR15499:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS
    AAMI BE83 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
    BS ISO 13779-3:2008 Implants for surgery. Hydroxyapatite Chemical analysis and characterization of crystallinity and phase purity
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    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 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
    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
    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
    BS EN ISO 10993-9 : 2009-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    UNI EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    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)
    I.S. EN ISO 10993-10:2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    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)
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    13/30285624 DC : 0 BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    16/30332223 DC : 0 BS ISO 6474-1 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 1: CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA
    17/30343686 DC : 0 BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
    AAMI ISO 10993-1:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
    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
    AAMI ISO 10993-15 : 2000 : R2011 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    DIN EN ISO 6872:2015-11 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015)
    ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
    ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
    ISO/TR 15499:2016 Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
    ISO 6872:2015 Dentistry Ceramic materials
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    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)
    BS EN ISO 10993-18:2009 Biological evaluation of medical devices Chemical characterization of materials
    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)
    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 10993-18:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005)
    EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
    I.S. EN ISO 10993-9:2009-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS (ISO 10993-9:2009)
    UNI EN ISO 10993-10 : 2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
    UNI EN ISO 10993-15 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    BS EN ISO 7405 : 2008 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
    UNI EN ISO 10993-1 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    10/30196848 DC : 0 BS ISO 6474-2 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 2: COMPOSITE MATERIALS BASED ON A HIGH PURITY ALUMINA MATRIX WITH ZIRCONIA REINFORCEMENT
    PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
    ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
    ISO 13779-3:2008 Implants for surgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity
    17/30302770 DC : 0 BS ISO 13779-3 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 3: CHEMICAL ANALYSIS AND CHARACTERIZATION OF CRYSTALLINITY RATIO AND PHASE PURITY
    CSA ISO 27427 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    13/30279967 DC : 0 BS EN ISO 6872 - DENTISTRY - CERAMIC MATERIALS
    08/30170164 DC : DRAFT AUG 2008 BS EN ISO 10993-10 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
    03/305222 DC : DRAFT MAR 2003 BS ISO 6474 - IMPLANTS FOR SURGERY - CERAMIC MATERIALS BASED ON HIGH PURITY ALUMINA
    AAMI BE78 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY
    ANSI/AAMI/ISO 10993-9:2009(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    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
    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)
    UNI EN ISO 7405 : 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    BS EN ISO 6872 : 2015 DENTISTRY - CERAMIC MATERIALS
    DIN EN ISO 10993-9:2010-04 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    ISO 16061:2015 Instrumentation for use 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
    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)
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    UNE-EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    I.S. EN ISO 10993-15:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000)
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    EN ISO 10993-15:2009 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 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
    BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
    BS ISO 27427:2013 Anaesthetic and respiratory equipment. Nebulizing systems and components
    AAMI ISO 10993-9 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    AAMI ISO 10993-15 : 2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
    ANSI/AAMI/ISO 10993-10:2010(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION
    PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
    ANSI/AAMI BE83:2006(R2011) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    07/30163763 DC : 0 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 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
    07/30162839 DC : 0 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 6872:2015 DENTISTRY - CERAMIC MATERIALS (ISO 6872:2015)
    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
    DIN EN ISO 10993-18 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    ISO 22803:2004 Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file
    EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    UNI EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    ONORM EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    DIN EN ISO 10993-10:2003-02 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

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

    ISO 5017:2013 Dense shaped refractory products — Determination of bulk density, apparent porosity and true porosity
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO 3310-1:2016 Test sieves Technical requirements and testing Part 1: Test sieves of metal wire cloth
    ISO 6872:2015 Dentistry Ceramic materials
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 9693:1999 Metal-ceramic dental restorative systems
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ASTM C 92 : 1995 TEST METHODS FOR SIEVE ANALYSIS AND WATER CONTENT OF REFRACTORY MATERIALS
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective