ISO 20417:2021

Abstract

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.

General information

Status
: Published

Publication date
: 2021-04

Corrected version (en)
: 2021-12

Corrected version (fr)
: 2021-12
Edition
: 1

Number of pages
: 72
Technical Committee
: ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
ICS
:
11.040.01 Medical equipment in general