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BSI - BS PD ISO/TS 17137

Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

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Organization: BSI
Publication Date: 30 June 2014
Status: inactive
Page Count: 36
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

PD ISO/TS 17137
September 30, 2021
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
A description is not available for this item.
BS PD ISO/TS 17137
September 30, 2019
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
A description is not available for this item.
BS PD ISO/TS 17137
June 30, 2014
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
A description is not available for this item.

References

This document references:
ISO/IEC GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Published by ISO on August 1, 2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
This document references:
ISO 11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Published by ISO on February 1, 2019
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and...
This document references:
ISO TR 14283 - Implants for surgery - Essential principles of safety and performance
Published by ISO on January 1, 2018
This document provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. It is often the case that...
This document references:
AAMI TIR42 - Evaluation of particulate associated with vascular medical devices
Published by AAMI on January 1, 2021
General This document addresses particulate released from intravascular medical devices that have direct contact with circulating blood. It is intended to assist intravascular medical device...
This document references:
AAMI TIR42 - Evaluation of particulate associated with vascular medical devices
Published by AAMI on January 1, 2021
General This document addresses particulate released from intravascular medical devices that have direct contact with circulating blood. It is intended to assist intravascular medical device...
This document references:
ISO TR 14283 - Implants for surgery - Essential principles of safety and performance
Published by ISO on January 1, 2018
This document provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. It is often the case that...
This document references:
ISO/IEC GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Published by ISO on August 1, 2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk...
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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