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  • ISO 13781:2017

    Current The latest, up-to-date edition.

    Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing

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

    Language(s):  English

    Published date:  20-07-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 13781:2017 describes methods for the determination of chemical and mechanical changes in poly(lactide)-based homopolymers, copolymers and/or blends induced under in vitro degradation testing conditions. This document covers polymers based on L-lactide, D-lactide, and/or D, L-lactide monomeric units.

    The purpose of this document is to compare and/or evaluate materials or processing conditions. This document also describes the fundamental physical and mechanical evaluations needed for an in vitro degradation characterization of an absorbable poly(lactide) or other hydrolysable material or device.

    ISO 13781:2017 is applicable to poly(lactide)-based homopolymers, copolymers and/or blends in bulk or processed forms and used for the manufacture of surgical implants, including finished products (packaged and sterilized implants).

    The test methods specified in this document are also intended to determine the in vitro degradation rate and related changes in material properties of polylactide-based copolymers and/or blends with various other comonomers, such as glycolid, trimethylene, carbonate and/or ε-caprolactone. Unless otherwise validated for a specific device, these in vitro methods cannot be used to definitively predict device behaviour under in vivo conditions.

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

    Committee ISO/TC 150/SC 1
    Development Note Supersedes ISO/DIS 13781 and ISO 15814. (07/2017)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
    DIN EN ISO 10993-13 E : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    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)
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
    AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
    CSA ISO 10993-13 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    ASTM F 2502 : 2017 : REDLINE Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    BS EN ISO 10993-9 : 2009-12 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    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)
    DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
    ISO 15814:1999 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing
    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 10993-13 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    ASTM F 1635 : 2016 : REDLINE Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    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
    13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
    AAMI ISO 10993-13:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 10993-9:2009(R2014) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
    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 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
    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)
    BS EN ISO 10993-13:2010 Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
    UNE-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)
    EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    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)
    AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    AAMI ISO 10993-9 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    UNI EN ISO 10993-9 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
    ANSI/AAMI/ISO 10993-13:2010(R2019) Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices

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    ISO 604:2002 Plastics — Determination of compressive properties
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 1805:2006 Fishing nets Determination of breaking force and knot breaking force of netting yarns
    ISO 14130:1997 Fibre-reinforced plastic composites — Determination of apparent interlaminar shear strength by short-beam method
    ISO 527-3:1995 Plastics Determination of tensile properties Part 3: Test conditions for films and sheets
    ISO 178:2010 Plastics Determination of flexural properties
    ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
    ISO 16014-1:2012 Plastics Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography Part 1: General principles
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