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Draft standard

OENORM EN ISO 15193

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
Edition 2024-01-15

Draft standard

OENORM EN 17180

Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing
Edition 2023-04-01

Draft standard

OENORM EN 14180

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Edition 2023-05-15

Rail systems for supporting medical equipment (ISO 19054:2005/DAM 1:2016) (Amendment)
Edition 2016-03-15

Draft standard

OEVE/OENORM EN 50447

Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)
Edition 2005-03-01

Draft standard

OENORM EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)
Edition 2024-04-15

Draft standard

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

Draft standard

OENORM EN 868-4

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Edition 2024-05-01

Draft standard

OENORM EN 868-2

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Edition 2024-05-01

Draft standard

OENORM EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
Edition 2024-07-15

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