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Standards [CURRENT]

DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
Edition 2013-01

Draft standard

DIN EN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021
Edition 2021-09

Draft standard

DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021
Edition 2021-09

Standards [available pre-publication]

DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022); German version EN ISO 18113-4:2024
Edition 2024-10

Standards [available pre-publication]

DIN EN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022); German version EN ISO 18113-5:2024
Edition 2024-10

Standards [CURRENT]

BS EN 13532

General requirements for in vitro diagnostic medical devices for self-testing
Edition 2002-05-08

General requirements for in vitro diagnostic medical devices for self-testing
Edition 2002-11-01

Standards [CURRENT]

SN EN 13532

General requirements for in vitro diagnostic medical devices for self-testing
Edition 2002-04

Standards [New]

BS EN ISO 18113-4

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
Edition 2024-06-12

Standards [New]

BS EN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling). Part 5: In vitro diagnostic instruments for self-testing
Edition 2024-06-12

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