Standard
Track updates
ISO 20417:2021
[Current]Medical devices - Information to be supplied by the manufacturer
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.
Published: 13/04/2021
Pages: 72
Content history
Content history
One-time Purchase
Access via web browser on any device
One-time purchase
Single publication
Offline access via PDF^
$375.02 AUD
Inclusive of GSTFormat *
Web Reader (PDF)
Licenses *
1 user
Total$375.02 AUD
IMPORTANT