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Draft standard [New]

OENORM EN ISO 80601-2-67

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2024)
Edition 2024-10-01

Draft standard [New]

OENORM EN ISO 80601-2-69

Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69:2024)
Edition 2024-10-01

Standards [CURRENT]

OENORM EN 14563

Chemical disinfectants and antiseptics - Quantitative carrier test for evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
Edition 2009-03-15

Standards [CURRENT]

OVE EN IEC 61010-2-101

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (EN IEC 61010-2-101:2022) (german version)
Edition 2024-01-01

Standards [CURRENT]

OENORM EN ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
Edition 2024-01-01

Standards [CURRENT]

OVE EN 50527-2-3

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators (german version)
Edition 2024-01-01

Standards [CURRENT]

OEVE/OENORM EN ISO 14708-7

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019, corrected version 2020-05)
Edition 2023-01-15

Standards [CURRENT]

OVE EN IEC 61223-3-6

Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation (german version)
Edition 2022-08-01

Standards [CURRENT]

OENORM EN ISO 11608-4

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Edition 2022-10-15

Standards [CURRENT]

OENORM EN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd 1:2018) (consolidated version)
Edition 2020-04-01

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