0 Stavka
Moj nalog
Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
15. 9. 2020.

Опште информације

90.60     3. 12. 2025.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 22442-2:2015

TRENUTNO

OBJAVLJEN
ISO 22442-2:2020
90.60 Završetak postupka preispitivanja standarda
3. 12. 2025.

Nacionalna preuzimanja

SRPS EN ISO 22442-2 :2021  
ISS

Medicinska sredstva za koja se koriste životinjska tkiva i njihovi derivati – Deo 2: Kontrole porekla, sakupljanja i rukovanja

60.60   Standard objavljen

Z076 Saznaj više