NA 063

DIN Standards Committee Medicine

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Drafts of NA 063

Number: 67

DIN EN ISO 21802 2021-04 Assistive products - Guidelines on cognitive accessibility - Daily time management (ISO 21802:2019); German and English version prEN ISO 21802:2021 More  Read draft and comment
DIN EN ISO 4307 2021-03 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO/DIS 4307:2021); German and English version prEN ISO 4307:2021 More  Read draft and comment
DIN EN ISO 16256 2021-03 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO/DIS 16256:2021); German and English version prEN ISO 16256:2021 More  Read draft and comment
DIN EN ISO 25424/A1 2021-03 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021); German and English version EN ISO 25424:2019/prA1:2021 More  Read draft and comment
DIN 58912-1 2021-03 Haemostaseology - Determination of the antithrombin activity - Part 1: Reference measurement procedure using a synthetic peptide substrate; Text in German and English More  Read draft and comment
DIN EN ISO 11138-8 2021-02 Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO/DIS 11138-8:2020); German and English version prEN ISO 11138-8:2020 More  Read draft and comment
DIN EN ISO 17664-1 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2020); German and English version prEN ISO 17664-1:2021 More  Read draft and comment
DIN EN 13726 2021-02 Test methods for wound dressings - Aspects of absorbency and moisture vapour transmission, waterproofness and conformability; German and English version prEN 13726:2021 More  Read draft and comment
DIN EN ISO 11137-2/A1 2021-02 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021 More  Read draft and comment
DIN 13277 2021-02 Refrigerators and freezers for the medical sector - Definitions, requirements, testing More  Read draft and comment

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