Standard [WITHDRAWN]
DIN EN ISO 5840-2:2016-05
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015
- German title
- Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015); Deutsche Fassung EN ISO 5840-2:2015
- Publication date
- 2016-05
- Original language
- German
- Pages
- 71
- Publication date
- 2016-05
- Original language
- German
- Pages
- 71
- DOI
- https://dx.doi.org/10.31030/2467466
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Overview
This International Standard has been prepared for surgically implanted heart valve substitutes with emphasis on specifying types of in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, preclinical in vivo, and clinical evaluations and labeling and packaging of the device. This process is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent issues. This part of ISO 5840 is to be used in conjunction with ISO 5840-1. The committee responsible for this standard is NA 027-02-17-01 UA "Herz- und Gefäßimplantate" ("Cardiovascular implants") at DIN.
Content
ICS
DOI
This document has been replaced by: DIN EN ISO 5840-2:2021-05 .
Corrected edition: Corrected document: Customers who purchased the previous document DIN EN ISO 5840-2:2015-12 received free of charge