11.100.10: In vitro diagnostic test systems

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  1. DIN EN 12286 [ Withdrawn ]

    In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

    standard by DIN-adopted European Standard, 02/01/1999 in English, German.

    Languages: English,German

    Corrigenda: DIN EN 12286 Corrigendum 1 (2000)

  2. DIN EN 12286 Corrigendum 1 [ Withdrawn ]

    Corrigenda to DIN EN 12286:1999-02 (EN 12286:1998/A1:2000)

    Corrigenda by DIN-adopted European Standard, 11/01/2000.

    Languages: German

  3. DIN EN 12287 [ Withdrawn ]

    In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials

    standard by DIN-adopted European Standard, 08/01/1999 in English, German.

    Languages: English,German

  4. DIN EN 12376

    In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

    standard by DIN-adopted European Standard, 04/01/1999 in English, German.

    Languages: English,German

  5. DIN EN 13532

    General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts

    standard by DIN-adopted European Standard, 08/01/2002.

    Languages: German, English

  6. DIN EN 13612

    Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts

    standard by DIN-adopted European Standard, 08/01/2002.

    Languages: German, English

  7. DIN EN 13640

    Stability testing of in vitro diagnostic reagent; German version EN 13640:2002, German and English texts

    standard by DIN-adopted European Standard, 06/01/2002.

    Languages: German, English

  8. DIN EN 13641

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts

    standard by DIN-adopted European Standard, 08/01/2002.

    Languages: German, English

  9. DIN EN 13975

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts

    standard by DIN-adopted European Standard, 11/01/2003.

    Languages: German, English

  10. DIN EN 14136

    Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

    standard by DIN-adopted European Standard, 08/01/2004 in English, German.

    Languages: English,German