IVD Design


EN 12322

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

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EN 13532

General requirements for in vitro diagnostic medical devices for self-testing

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EN 13612

Performance evaluation of in vitro diagnostic medical devices

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EN 13640

Stability testing of in vitro diagnostic reagents

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EN 13975

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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EN 14254

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

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EN 14820

Single-use containers for human venous blood specimen collection

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EN ISO 15193

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

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EN ISO 15194

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation

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EN ISO 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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