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Draft standard [Pre-order]

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 11615

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition 2022-12

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015); German version EN ISO 12417-1:2015
Edition 2016-02

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Standards [CURRENT]

DIN EN 14476

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1); German version EN 14476:2013+A2:2019
Edition 2019-10

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

Standards [CURRENT]

DIN 51893

Gas analysis - Requirements for specifications of analysers/analytical equipment
Edition 2013-12

Standards [CURRENT]

DIN ISO 11040-4

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015)
Edition 2017-07

Draft standard [New]

DIN EN 14476

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1); German and English version prEN 14476:2024
Edition 2024-07

Technical rule [CURRENT]

DIN SPEC 91323

Temperature conditioned transport equipment used for the distribution of pharmaceutical products (for human beings or veterinary use) - Guidelines for qualification
Edition 2016-03

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