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Standards [CURRENT]

DIN EN ISO 13408-7

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015
Edition 2015-11

Standards [CURRENT]

DIN EN IEC 80001-1 ; VDE 0756-1:2023-02

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); German version EN IEC 80001-1:2021
Edition 2023-02

Draft standard

OEVE/OENORM EN 50339

Medical devices - X-ray film
Edition 2000-06-01

Technical rule [CURRENT]

VDI 5703 Blatt 1

Systematical development for a model-based testing of medical devices - Fundamentals
Edition 2021-12

Standards [CURRENT]

SN EN 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices
Edition 2015-04

Draft standard

DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024); German and English version prEN ISO 7405:2024
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Edition 2021-12

Technical rule [CURRENT]

VDI 2083 Blatt 21

Cleanroom technology - Cleanliness of medical devices in the manufacturing process
Edition 2019-10

Standards [CURRENT]

DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018
Edition 2019-03

Technical rule [CURRENT]

VDI 5707 Blatt 1

Retesting of active medical devices in medical use - Testing principles
Edition 2023-02

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