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Technical rule [CURRENT]

OVE-Richtlinie/ONR R 8

Guideline for procurement and operation of medical devices in IT-networks
Edition 2012-06-01

Technical rule [CURRENT]

ONR 111107-1

Quality management for supply with medical devices for rehabilitation - Part 1: Supply companies - Specific conditions
Edition 2007-11-01

Technical rule [CURRENT]

ONR 111107-2

Quality management for supply with medical devices for rehabilitation - Part 2: Rehabilitation engineer - Requirements, knowledge and proof of relevant training
Edition 2008-08-01

Technical rule [CURRENT]

ONR 111107-3

Quality management for supply with medical devices for rehabilitation - Part 3: Rehabilitation technical activities - Process quality for all devices
Edition 2008-08-01

Technical rule [CURRENT]

ONR 111107-4

Quality management for supply with medical devices for rehabilitation - Part 4: Wheelchairs - Selection and adaptation of manually propelled wheelchairs
Edition 2011-08-01

Technical rule [CURRENT]

ONR 111107-5

Quality management for supply with medical devices for rehabilitation - Part 5: Wheelchairs - Selection and adaptation of electrically powered wheelchairs and auxiliary drive systems
Edition 2013-05-01

Technical rule [CURRENT]

ONR 111107-6

Quality management for supply with medical devices for rehabilitation - Part 6: Walking aids - Selection and adaptation
Edition 2016-06-15

Technical rule [CURRENT]

ONR 112040

Selection of reprocessable medical devices
Edition 2012-04-01

Standards [CURRENT]

SN 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
Edition 2021-10

Standards [CURRENT]

SN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Edition 2019-07

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