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Draft standard

DIN 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/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021
Edition 2021-09

Standards [CURRENT]

DIN EN ISO 11238

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018); German version EN ISO 11238:2018
Edition 2018-11

Standards [CURRENT]

DIN EN ISO 20184-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018); German version EN ISO 20184-1:2018
Edition 2019-06

Standards [CURRENT]

DIN EN ISO 20186-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
Edition 2019-08

Standards [CURRENT]

DIN EN ISO 20184-2

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018); German version EN ISO 20184-2:2018
Edition 2019-06

Standards [CURRENT]

DIN EN ISO 13408-2

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018
Edition 2018-06

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 ISO 22367

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020
Edition 2020-09

Draft standard [New]

DIN EN ISO 4074

Natural rubber latex male condoms - Requirements and test methods (ISO/DIS 4074:2024); German and English version prEN ISO 4074:2024
Edition 2024-09

Draft standard [Withdrawn]

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022
Edition 2022-11

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