Name: AAMI BE83 : 2006
Brand: AAMI

AAMI BE83 : 2006

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

31-08-2021

Language(s)

English

Published date

01-01-2011

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	WG 14
DocumentType	Standard
Pages	31
ProductNote	Reconfirmed 2006
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Superseded
SupersededBy	ANSI/AAMI BE83:2006(R2011)

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