ISO 13781:2017
Current
Current
The latest, up-to-date edition.
Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
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Language(s)
English
Published date
20-07-2017
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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.
| Committee |
ISO/TC 150/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 13781 and ISO 15814. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| NEN ISO 13781 : 2017 | Identical |
| BS ISO 13781:2017 | Identical |
| BIS IS 5347-16 : 2002 | Identical |
| GOST R ISO 13781 : 2011 | Identical |
| 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 |
| 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) |
| 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 <emph type="bdit">in vitro</emph> 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 |
| ISO 13934-1:2013 | Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and elongation at maximum force using the strip method |
| ISO 6721-2:2008 | Plastics Determination of dynamic mechanical properties Part 2: Torsion-pendulum method |
| ASTM D 4001 : 2013 : REDLINE | Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering |
| ISO 1628-1:2009 | Plastics Determination of the viscosity of polymers in dilute solution using capillary viscometers Part 1: General principles |
| ISO 16014-4:2012 | Plastics Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography Part 4: High-temperature method |
| ISO 2062:2009 | Textiles Yarns from packages Determination of single-end breaking force and elongation at break using constant rate of extension (CRE) tester |
| ASTM E 284 : 2017 : REDLINE | Standard Terminology of Appearance |
| ASTM D 5296 : 2011 : REDLINE | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
| ASTM F 1635 : 2016 : REDLINE | Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| ISO 527-2:2012 | Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
| ISO 180:2000 | Plastics Determination of Izod impact strength |
| ISO 16014-2:2012 | Plastics Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography Part 2: Universal calibration method |
| ISO 3146:2000 | Plastics — Determination of melting behaviour (melting temperature or melting range) of semi-crystalline polymers by capillary tube and polarizing-microscope methods |
| ISO 16014-3:2012 | Plastics Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography Part 3: Low-temperature method |
| DIN 12448:1977-09 | Paper laboratory ware; filter paper |
| ISO 16014-5:2012 | Plastics Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography Part 5: Method using light-scattering detection |
| 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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