60.60 Standard published Mar 17, 2026
ISO
ISO/TC 210 Quality management and corresponding general aspects for medical devices
International Standard
11.040.01 Medical equipment in general
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or 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.
WITHDRAWN
ISO 20417:2021
PUBLISHED
ISO 20417:2026
60.60
Standard published
Mar 17, 2026