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NS EN ISO 10993-18 : 2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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Withdrawn date

06-16-2020

Published date

01-12-2013

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

Specifies a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Withdrawn
SupersededBy

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