Name: ANSI/AAMI BE83:2006(R2011)
Brand: AAMI
Price: 242.26 AUD

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-12-2011

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 10993-18:2005 and
rationale for major technical deviations
Major technical deviations from ISO 10993-18:2005
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 Quantitative information
7 Chemical characterization parameters and methods
  7.1 General
  7.2 Polymers
  7.3 Metals and alloys
  7.4 Ceramics
  7.5 Natural macromolecules
8 Reporting of data obtained
Annex A (informative) - Information sources for chemical
                        characterization
Bibliography

Defines a framework for the identification of a material and the identification and quantification of its chemical constituents.

Committee	ISO/TC 194
DocumentType	Standard
ISBN	1-57020-257-5
Pages	31
ProductNote	Reconfirmed 2011
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI BE83 : 2006

Standards	Relationship
ISO 10993-18:2005	Identical

EN 12442-3 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
ISO 5725-1:1994	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 5832-1:2016	Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
ISO 10993-13:2010	Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ISO 10993-14:2001	Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
EN 12442-1 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 12442-2 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING

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ANSI/AAMI BE83:2006(R2011)

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Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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