Standard

ISO 20417:2026

Draft

Note: This standard has a draft: ISO 20417:2026

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Services

Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Expires:
  • Edition: 2
  • Version: 1
  • Document type: IS
  • ICS 11.040.01
  • ISO TC ISO/TC 210

Product Relations

Product life cycle