EN 12442-3:2000

Name: EN 12442-3:2000
Brand: CEN
SKU: EN 12442-3:2000
Price: 40.11 EUR
Availability: InStock
Rating: 4 (66 reviews)

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents

Publication date: Jan 22, 2004

General information

Current stage: 99.60 Withdrawal effective Dec 15, 2007

Originator: CEN

Owner: CEN/TC 316 Medical products utilizing cells, tissues and/or their derivatives

Type: European Norm

ICS: 11.120.01 Pharmaceutics in general

Buying

Status: Withdrawn

PDF - €40.11

Languages: English

Buy

Scope

This part of prEN 12442 specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN
EN 12442-3:2000
99.60 Withdrawal effective
Dec 15, 2007

REVISED BY

PUBLISHED
EN ISO 22442-3:2007