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SIST EN 12442-3:2001

(Main)

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

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

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.

Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 3: Validierung der Abreicherung und/oder Inaktivierung von Viren und übertragbaren Krankheitserregern

Dieser Teil der EN 12442 legt Anforderungen für die Validierung der Abreicherung und/oder Inaktivierung von Viren und/oder übertragbaren Krankheitserregern bei der Herstellung von Medizinprodukten (mit Ausnahme von in-vitro Diagnostik-Medizinprodukten), die Materialien tierischer Herkunft enthalten, fest. Er ist nicht anwendbar auf Bakterien, Pilze und Hefen.

Tissus animaux et leurs dérivés utilisés dans la fabrication des dispositifs médicaux - Partie 3: Validation de l'élimination et/ou de l'inactivation des virus et autres agents transmissibles

La présente partie du prEN 12442 spécifie les exigences relatives a la validation de l'élimination et/ou de l'inactivation des virus et/ou agents transmissibles au cours de la fabrication des dispositifs médicaux (a l'exception des dispositifs médicaux de diagnostic in vitro) utilisant des matériaux d'origine animale. Elle ne s'applique pas aux bactéries, moisissures et levures.

Živalska tkiva in njihovi derivati, uporabljeni v proizvodnji medicinskih pripomočkov – 3. del: Validacija pri izločitvi in/ali inaktivaciji virusov in nalezljivih agensov

General Information

Status
Withdrawn
Publication Date
31-Oct-2001
Withdrawal Date
06-Feb-2008
ICS
11.120.01 - Pharmaceutics in general
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
29-Jan-2008
Due Date
21-Feb-2008
Completion Date
07-Feb-2008
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 12442-3:2000 - 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

Relations

Replaced By
SIST EN ISO 22442-3:2008 - Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Effective Date
01-Apr-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12442-3:2001
01-november-2001
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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
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten
eingesetzt werden - Teil 3: Validierung der Ab
...

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