DIN Standards Committee Optics and Precision Mechanics
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
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
