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.

ISO 20417:2021(E) Introduction This document provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or …

2021年9月6日 · ISO 20417:2021 is meant as a replacement for an older standard, EN 1041. The goal of the new standard is to create a source of generally applicable information …

2021年5月18日 · ISO 20417 offers manufacturers real guidance on how to meet the requirements for the accompanying information. Manufacturers would be well advised to review their …

This corrected version of ISO 20417:2021 incorporates the following corrections:

This second edition cancels and replaces the first edition (ISO 20417:2021), which has been technically revised. The main change are as follows: ? updated the normative references;

An international standard that defines the information to be supplied by the manufacturer of Medical Devices is ISO 20417:2021, with the latest version as ISO 20417:2021. Besides, ISO …

Ensure compliance, facilitate trade, and increase trust in your medical devices with BS EN ISO 20417:2021. This standard specifies the essential information to be supplied by …

A new standard is expected to be published in early 2021: it is named ISO 20417 Medical devices — Information to be supplied by the manufacturer and it will define the regulatory requirements …