SIST EN ISO 22442-2:2021

Oznaka standarda: SIST EN ISO 22442-2:2021
Koda projekta: 00206083
Organizacija: SIST
Naslov (angleški): Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
Naslov (slovenski): Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del: Nadzor pri nabavi, zbiranju in ravnanju z njimi (ISO 22442-2:2020)
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Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 22442-2:2021 angleški jezik Active SIST-F: 65.34 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.040.99 11.120.01
Status: Objavljen
Objavljen: 01-Feb-2021
Refer. št. objave: Sporocila 2021-02
Referenčna oznaka: EN ISO 22442-2:2020
Področje projekta (angleško): This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 22442-2:2016 - Medicinski pripomočki, ki uporabljajo živalska tkiva in njihove derivate - 2. del: Nadzor pri nabavi, zbiranju in ravnanju (ISO 22442-2:2015) 01-Feb-2021


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