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Draft standard

DIN EN ISO 23500-1

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO/DIS 23500-1:2022); German and English version prEN ISO 23500-1:2022
Edition 2023-01

Draft standard

DIN EN ISO 23500-2

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO/DIS 23500-2:2022); German and English version prEN ISO 23500-2:2022
Edition 2022-12

Draft standard [New]

DIN EN ISO 15883-7

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024); German and English version prEN ISO 15883-7:2024
Edition 2024-03

Technical Specification

DIN/TS 5343

Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
Edition 2022-04

Standards [CURRENT]

DIN EN ISO 29621

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017); German version EN ISO 29621:2017
Edition 2017-07

Technical Specification

DIN ISO/TS 17665-2

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009
Edition 2009-07

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

Standards [CURRENT]

OENORM EN 16602-70-58

Space product assurance - Bioburden control of cleanrooms
Edition 2016-03-01

Standards [CURRENT]

BS EN 16602-70-58

Space product assurance. Bioburden control of cleanrooms
Edition 2015-09-30

Standards [CURRENT]

SN EN 16602-70-58

Space product assurance - Bioburden control of cleanrooms
Edition 2015-12

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