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BS EN ISO 10993-18:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Chemical characterization of materials
Available format(s)

Hardcopy , PDF

Superseded date

12-14-2020

Language(s)

English

Published date

06-30-2009

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 Step 1 - Qualitative information
  6.3 Step 2 - Material equivalence
  6.4 Step 3 - Quantitative information
  6.5 Step 4 - Quantitative risk assessment
  6.6 Step 5 - Estimated clinical exposure to chemicals
      present
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 (normative) - Flowchart summarizing the stepwise
        generation of chemical characterization data for
        use in toxicological risk assessment
Annex B (informative) - Information sources for chemical
        characterization
Annex C (informative) - Principles for judging toxicological
        equivalency
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices

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

Committee
CH/194
DevelopmentNote
Supersedes 03/100426 DC. (11/2005)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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 10993-17:2002 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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