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DIN Standards Committee Health Technologies

DIN EN ISO 13485 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 14644-1 2016-06 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015); German version EN ISO 14644-1:2015 More 
DIN EN ISO 14644-16 2020-06 Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019); German version EN ISO 14644-16:2019 More 
DIN EN ISO 14644-17 2021-06 Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021); German version EN ISO 14644-17:2021 More 
DIN EN ISO 14644-2 2016-05 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015); German version EN ISO 14644-2:2015 More 
DIN EN ISO 14644-3 2020-08 Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06); German version EN ISO 14644-3:2019 More 
DIN EN ISO 14644-7 2005-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 More 
DIN EN ISO 19011 2018-10 Guidelines for auditing management systems (ISO 19011:2018); German and English version EN ISO 19011:2018 More 
DIN EN ISO 9000 2015-11 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More 
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
DIN EN 17141 2021-02 Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020 More