DS/EN ISO 22442-2:2015 ( Tilbagetrukket * )

Medicinsk udstyr fremstillet ved brug af animalsk væv og dets derivater - Del 2: Kontrol af oprindelse, indsamling og håndtering


Status:
Tilbagetrukket *
Type:
Standard
Sprog:
Engelsk
Kategori:
Erstattet af:
Pris fra:
kr. 507,00
Lovgivning:

Bemærk: Denne standard er endnu ikke harmoniseret, og giver derfor ikke formodningsret. Indtil harmonisering af denne standard er opnået, kan følgende benyttes:


Lovgivning

Bemærk: Denne standard er endnu ikke harmoniseret, og giver derfor ikke formodningsret. Indtil harmonisering af denne standard er opnået, kan følgende benyttes:

Links

Beskrivelse

This part of ISO 22442 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 1 – Selective sourcing is considered to be especially important for transmissible spongiform
encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination
and/or inactivation of viruses and TSE agents.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
This part of ISO 22442 does not specify a quality management system for the control of all stages of
production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture,
but it does specify requirements for some of the elements of a quality management system. Attention is drawn
to the standards for quality management systems (see ISO 13485) that control all stages of production or
reprocessing of medical devices. The quality management system elements that are required by this part of
ISO 22442 can form a part of a quality management system conforming to ISO 13485.
NOTE 2 – A general principle for the application of this International Standard is that it is advisable to give due
consideration to the requirements and recommendations contained in all three parts of the standard.


Antal sider: 30

Udgivet: 2016-02-04

Godkendelsesdato: 2015-12-15

Internationale relationer : EN ISO 22442-2:2015 IDT ISO 22442-2:2015 IDT

ICS: 11.100.99 - Andre standarder vedrørende laboratoriemedicin

Varenummer: M299769

*Standarden kan benyttes til og med: 30-06-2021:00


Udvalg og komiteer

Komite

  • CEN/TC 316
  • ISO/TC 194/SC 1
  • ISO/TC 194/SC 1

Dansk udvalg

DS/S-258