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PD ISO/TR 37137:2014

Current
Current

The latest, up-to-date edition.

Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2014

Foreword
1 Scope
2 Terms and definitions
3 General considerations
4 Sterilization considerations
5 Drug-device combination product considerations
6 Part listing and description of absorbable related
  issues in addition to the relevant parts of
  ISO 10993 series 'Biological evaluation
  of medical devices'
Annex A (informative) - Nomenclature of absorb,
        degrade and related terms
Bibliography

Gives interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices.

The objective of this Technical Report is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.

Committee
CH/194
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TR 37137:2014 Identical

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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
ISO/TR 15499:2016 Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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