ANSI/AAMI/ISO TIR10993-19:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
13-02-2024
English
30-01-2006
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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
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.
| Committee |
WG 14
|
| DocumentType |
Standard
|
| ISBN |
1570202664
|
| Pages |
29
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO/TS 10993-19:2006 | Identical |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| 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: 2014 : REDLINE | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting (Withdrawn 2023) |
| 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 |
| 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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