• There are no items in your cart

ANSI/AAMI/ISO TIR10993-19:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
Available format(s)

Hardcopy , PDF

Superseded date

02-13-2024

Language(s)

English

Published date

01-30-2006

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Superseded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
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

View more information
US$148.00
Excluding Tax where applicable

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, flexible and cost effective.