EN 12442-3:2000
(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 à la validation de l'élimination et/ou de l'inactivation des virus et/ou agents transmissibles au cours de la fabrication des dispositifs médicaux (à 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- Withdrawn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
- 19-Sep-2000
- Withdrawal Date
- 14-Dec-2007
- Technical Committee
- CEN/TC 316 - Medical devices utilizing tissues
- Drafting Committee
- CEN/TC 316 - Medical devices utilizing tissues
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Dec-2007
- Completion Date
- 15-Dec-2007
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12442-3:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "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 standard covers: 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.
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.
EN 12442-3:2000 is classified under the following ICS (International Classification for Standards) categories: 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12442-3:2000 has the following relationships with other standards: It is inter standard links to EN ISO 22442-3:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12442-3:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12442-3:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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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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