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BSI - BS EN ISO 10993-17

Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances

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Organization: BSI
Publication Date: 30 June 2009
Status: active
Page Count: 36
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

BS EN ISO 10993-17
November 30, 2023
Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents
A description is not available for this item.
BS EN ISO 10993-17
June 30, 2009
Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
A description is not available for this item.
BS EN ISO 10993-17
April 30, 2003
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
A description is not available for this item.

References

This document references:
ISO 10993-1 FRENCH - Évaluation biologique des dispositifs médicaux - Partie 1: Évaluation et essais au sein d'un processus de gestion du risque
Published by ISO on August 1, 2018
A description is not available for this item.
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document is referenced by:
BS EN ISO 22794 - Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
Published by BSI on September 30, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-13 - Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by BSI on October 31, 2010
A description is not available for this item.
This document is referenced by:
BS EN ISO 10993-14 - Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
Published by BSI on June 30, 2009
A description is not available for this item.
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