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UNE-EN ISO 10993-9:2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
Available format(s)

Hardcopy , PDF

Superseded date

25-05-2022

Language(s)

Spanish, Castilian, English

Published date

09-06-2010

1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
      4.1 General
      4.2 Preliminary considerations
      4.3 Study design
      4.4 Characterization of degradation products from
             medical devices
5 Study report
Annex A (normative) Considerations of the need for
                    degradation studies
Annex B (informative) Biodegradation study considerations
Annex ZA (normative) Normative references to international
                     publications with their relevant
                     European publications
Bibliography

Gives general principles of systematic evaluating of the potential and observed biodegradation of medical devices and for designing and performing biodegradation studies.

Committee
CTN 111
DocumentType
Standard
Pages
22
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10271:2011 Dentistry Corrosion test methods for metallic materials
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

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$122.02
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