ISO 20417:2021 A standard is reviewed every 5 years Stage: 90.92 (To be revised)

For the purposes of this document, the terms and definitions given in ISO 13485:2016, ISO 14971:2019, ISO 16142-1:2016, ISO 16142-2:2017 and IEC 62366-1:2015+AMD1:2020 as specified in Annex I and the following definitions apply.

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 accompanying information using ISO 20417 and, if they have them, update their accompanying information (labeling) checklists.

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? deletion of 4 b) and 6.1.2.d) 1). This document provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.

general aspects for medical complete feedback or questions document corrected version of ISO 20417:2021 incorporates the following corrections: of these bodies be found should at www.iso.org/members.html. be directed to the user’s national standards body. label corrected symbols or safety-related colours, they shall be explained in the

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.

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that …