SIST EN ISO 20417:2021

Oznaka standarda: SIST EN ISO 20417:2021
Koda projekta: JT003053
Organizacija: SIST
Naslov (angleški): Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Naslov (slovenski): Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021)
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SIST EN ISO 20417:2021 angleški jezik Active SIST-M: 119.79 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 01.110 11.040.01
Status: Objavljen
Objavljen: 01-jul-2021
Refer. št. objave: Sporocila 2021-07
Referenčna oznaka: EN ISO 20417:2021
Področje projekta (angleško): 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.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN 1041:2008+A1:2013 - Informacije, ki jih proizvajalec priloži medicinskim pripomočkom 01-jul-2021


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