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Standards [CURRENT]

SN EN ISO 13408-7

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
Edition 2015-10

Standards [New]

OENORM EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
Edition 2024-08-01

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

Draft standard

OENORM EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices
Edition 2023-03-01

Standards [New]

OENORM EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Edition 2024-08-15

Standards [CURRENT]

OENORM EN 1641

Dentistry - Medical devices for dentistry - Materials
Edition 2010-03-15

Standards [CURRENT]

OENORM EN 1640

Dentistry - Medical devices for dentistry - Equipment
Edition 2010-03-15

Standards [CURRENT]

OENORM EN 1639

Dentistry - Medical devices for dentistry - Instruments
Edition 2010-03-15

Standards [CURRENT]

OENORM K 1017

Medical devices for rehabilitation - Requirements for the selection of stair-climbing devices
Edition 2019-08-15

Draft standard

OENORM EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023)
Edition 2023-03-01

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