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BSI - BS PD ISO/TR 37137

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

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Organization: BSI
Publication Date: 30 June 2014
Status: active
Page Count: 26
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS PD ISO/TR 37137
June 30, 2014
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
A description is not available for this item.

References

This document references:
ISO 10993-15 - Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Published by ISO on November 1, 2019
This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples...
This document references:
ISO 10993-17 - Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances
Published by ISO on December 1, 2002
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating...
This document references:
ISO 10993-14 - Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
Published by ISO on November 15, 2001
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the...
This document references:
ISO TS 10993-20 - Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
Published by ISO on August 1, 2006
This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for...
This document references:
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document references:
ISO TS 10993-20 - Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
Published by ISO on August 1, 2006
This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for...
This document is referenced by:
ASTM F3160 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
Published by ASTM on February 1, 2021
This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This...
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