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BSI - 23/30437899 DC

Draft BS ISO 5910 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices

pending
Organization: BSI
Publication Date: 10 May 2023
Status: pending
Page Count: 109
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

23/30437899 DC
May 10, 2023
Draft BS ISO 5910 Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
A description is not available for this item.
BS ISO 5910
June 30, 2018
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
A description is not available for this item.

References

This document references:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
ISO TR 22442-4 - Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Published by ISO on December 1, 2010
This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal...
This document references:
ISO TS 17665-3 - Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
Published by ISO on April 15, 2013
This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and...
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...
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