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download between 0-24 hoursReleased: 2021
ISO 20417:2021
ISO 20417:2021-Medical devices — Information to be supplied by the manufacturer
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Standard´s number: | ISO 20417:2021 |
Pages: | 72 |
Edition: | 1 |
Released: | 2021 |
Pages (English): | 72 |
Pages (French): | 72 |
DESCRIPTION
ISO 20417:2021
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.
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