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Normas DIN – AENOR
DIN 58950-3:2020-11

DIN 58950-3:2020-11

Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English / Note: Date of issue 2020-10-16*Intended as replacement for DIN 58950-3 (2011-01).

Stérilisation - Stérilisateurs à la vapeur d'eau destinés à la stérilisation de produits pharmaceutiques - Partie 3: Essais; Texte en allemand et anglais / Attention: Date de parution 2020-10-16*Prévu pour remplacer DIN 58950-3 (2011-01).

Sterilisation - Dampf-Sterilisatoren für pharmazeutische Sterilisiergüter - Teil 3: Prüfungen; Text Deutsch und Englisch / Achtung: Erscheinungsdatum 2020-10-16*Vorgesehen als Ersatz für DIN 58950-3 (2011-01).

Fecha:
2020-11 /Active
Resumen:
This standard applies for the testing of steam sterilizers for pharmaceutical products in accordance with DIN 58950 2. It describes the tests the operator and manufacturer should perform before using the sterilizer for the production of sterile pharmaceutical products. Steam sterilizers in accordance with this standard are sterilizers which use moist heat as sterilizing agent. This includes procedures using saturated steam, steam/air mixtures or hot water spray processes.
Keywords:
Acceptance (approval), Acceptance inspection, Amount of inspection, Blank forms, Check lists, Control charts, Delivery conditions, Forms (paper), Inspection, Medical equipment, Medical sciences, Pharmaceutical technology, Pharmacy, Steam sterilizers, Sterilization (hygiene), Sterilizers, Testing
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