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OENORM EN 868-6
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Edition
2024-05-01
OEVE/OENORM EN ISO 20417
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
Edition
2022-09-01
OENORM EN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, corrected version 2018-12)
Edition
2019-03-01
OENORM EN ISO 9626
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
Edition
2016-12-15
OENORM EN 14079
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
Edition
2003-07-01
OENORM EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Edition
2018-01-15
OENORM EN ISO 10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Edition
2021-09-15
OENORM EN ISO 14160
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
Edition
2021-10-15
MedPGDVV
Allgemeine Verwaltungsvorschrift zur Durchführung des Medizinproduktegesetzes (Medizinprodukte-Durchführungsvorschrift - MPGVwV)
Edition
2012-05-18
OENORM EN ISO 15883-6
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
Edition
2016-03-15