DPS
Drejtoria e Përgjithshme e Standardizimit
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 20417:2021

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

Dec 21, 2021

General information

60.60     Dec 21, 2021

DPS

European Norm

11.040.01  

English  

Buying

Published

Language in which you want to receive the document.

Scope

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 1041:2008+A1:2013

NOW

PUBLISHED
SSH EN ISO 20417:2021
60.60 Standard published
Dec 21, 2021

Related project

Adopted from EN ISO 20417:2021