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OENORM EN ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)
Edition
2022-12-01
OENORM EN ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019) (consolidated version)
Edition
2022-10-01
OEVE/OENORM EN ISO 14708-2
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
Edition
2023-01-15
OENORM EN ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Edition
2023-08-15
OENORM EN ISO 11607-1/A1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019/Amd 1:2023) (Amendment)
Edition
2024-03-15
OENORM EN ISO 11607-2/A1
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019/Amd 1:2023) (Amendment)
Edition
2024-03-15
OENORM EN ISO 20916
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
Edition
2024-08-01
NF C99-130-2-1 ; NF EN 50527-2-1:2017-02-18
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1 : specific assessment for workers with cardiac pacemakers
Edition
2017-02-18
OENORM EN ISO 18113-2
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Edition
2024-10-01
OENORM EN ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)
Edition
2024-10-01