NA 027

DIN Standards Committee Optics and Precision Mechanics

Standards [Withdrawn]

DIN EN ISO 5840-2
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015

Title (German)

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015); Deutsche Fassung EN ISO 5840-2:2015

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.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-05-06 AA - Cardiovascular implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Edition 2016-05
Original language German
Translation English
Price from 158.40 €
Table of contents

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