ISO/DIS 20417

This Draft International Standard is in the enquiry phase with ISO members.

Will replace ISO 20417:2021

ISO/DIS 20417

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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
: Under development

You can help develop this draft international standard by contacting your national member

Stage
: DIS ballot initiated: 12 weeks [40.20]
Edition
: 2

Number of pages
: 66
Technical Committee :
ISO/TC 210

ICS :
11.040.01
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