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Standards [CURRENT]

ISO 14644-13

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
Edition 2017-06

Standards [CURRENT]

ISO 14644-14

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration
Edition 2016-09

Standards [CURRENT]

SN EN ISO 14644-13

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
Edition 2017-12

Publication

Aseptische Herstellung

Edition 2016-10

Publication

Professionelles Risikomanagement von Medizinprodukten

Ein Leitfaden zur praktischen Umsetzung der DIN EN ISO 14971 im Fokus der MDR- und IVDR-Anforderungen
Edition 2023-05

Publication

Qualitätsmanagement für Hersteller von Medizinprodukten

Praxisleitfaden zur DIN EN ISO 13485 und den neuen EU-Verordnungen
Edition 2019-04

Publication

Laboreinrichtungen

Edition 2020-09

Publication

Nicht aktive Medizinprodukte

Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition 2022-06

Publication

Sterilisation und Aufbereitung von Medizinprodukten

Niedertemperatur-Sterilisation - Anforderungen an Verfahren, Geräte und zugehörige Ausrüstung
Edition 2020-12

Publication

Adhesive Technology

Basic principles
Edition 2012-09

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