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OVE EN IEC 80001-1
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software ((IEC 80001-1:2021) EN IEC 80001-1:2021) (german version)
Edition
2023-03-01
ONR 111107-1
Quality management for supply with medical devices for rehabilitation - Part 1: Supply companies - Specific conditions
Edition
2007-11-01
MedPAbgV
Verordnung über die Abgabe von Medizinprodukten und zur Änderung medizinprodukterechtlicher Vorschriften (Artikel 1 Verordnung zur Regelung der Abgabe von Medizinprodukten (Medizinprodukte-Abgabenverordnung - MPAV))
Edition
2014-07-25
OENORM EN ISO 22610
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
Edition
2006-11-01
MedPDG
Gesetz zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Medizinprodukte-EU-Anpassungsgesetz - MPEUAnpG) (Artikel 1 Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz - MPDG))
Edition
2020-04-28
OENORM EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd.1:2013 + Amd.2:2018) (consolidated version)
Edition
2020-04-01
OENORM EN 868-3
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Edition
2017-04-15
SN EN ISO 11135/A1
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018); Amendment A1
Edition
2020-06
ONR 111107-6
Quality management for supply with medical devices for rehabilitation - Part 6: Walking aids - Selection and adaptation
Edition
2016-06-15
MedPAbgVÄndV 1
Erste Verordnung zur Änderung der Medizinprodukte-Abgabeverordnung
Edition
2018-09-21
