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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

Draft standard

DIN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
Edition 2023-05

Draft standard [New]

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
Edition 2024-06

Technical Specification [CURRENT]

DIN CEN ISO/TS 19256 ; DIN SPEC 13236:2017-06

Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016); English version CEN ISO/TS 19256:2017
Edition 2017-06

Technical Specification [New]

DIN CEN ISO/TS 5499

Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024); English version CEN ISO/TS 5499:2024
Edition 2024-05

Technical Specification [CURRENT]

DIN CEN ISO/TS 19844 ; DIN SPEC 13261:2017-12

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Edition 2017-12

Technical Specification [CURRENT]

DIN CEN ISO/TS 20451 ; DIN SPEC 13264:2018-11

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017); English version CEN ISO/TS 20451:2018
Edition 2018-11

Technical rule [CURRENT]

VDI 2083 Blatt 3.1

Cleanroom technology - Metrology in cleanroom air - Monitoring
Edition 2012-06

Technical rule [CURRENT]

VDI 6305

Technical good manufacturing practice - Application guideline for projects in the GMP environment
Edition 2018-06

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