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DD ISO/TS 10993-19:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
Available format(s)

Hardcopy , PDF

Superseded date

16-03-2020

Language(s)

English

Published date

31-08-2006

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
CH/194
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
ISO/TS 10993-19:2006 Identical

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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