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Draft standard

DIN EN ISO 5649

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 17511

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
Edition 2021-11

Standards [CURRENT]

DIN EN 1614

Health informatics - Representation of dedicated kinds of property in laboratory medicine; English version EN 1614:2006
Edition 2006-12

Standards [New]

DIN EN ISO 11139

Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018 + Amd 1:2024); German and English version EN ISO 11139:2018 + A1:2024
Edition 2024-06

Draft standard

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021
Edition 2021-09

Standards [CURRENT]

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
Edition 2013-01

Standards [CURRENT]

DIN EN 1068

Health informatics - Registration of coding systems; English version EN 1068:2005
Edition 2006-09

Draft standard

DIN EN 13060

Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023
Edition 2023-05

Standards [CURRENT]

DIN 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 (ISO 15194:2009); German version EN ISO 15194:2009
Edition 2009-10

Standards [CURRENT]

DIN EN ISO 21090

Health Informatics - Harmonized data types for information interchange (ISO 21090:2011); English version EN ISO 21090:2011, only on CD-ROM
Edition 2011-06

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