TSE - TS EN ISO 5840-1
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
active, Most Current
| Organization: | TSE |
| Publication Date: | 23 October 2015 |
| Status: | active |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
This part of ISO 5840 is applicable to heart valve substitutesintended for human implantation and provides general requirements.It is applicable to both newly developed and modified heart valvesubstitutes and to the accessories, packaging, and labellingrequired for their implantation and for determining the appropriatesize of the heart valve substitute to be implanted.
Document History
TS EN ISO 5840-1
October 23, 2015
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
This part of ISO 5840 is applicable to heart valve substitutesintended for human implantation and provides general requirements.It is applicable to both newly developed and modified heart...