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DIN Standards Committee Health Technologies

DIN EN ISO 13485 [CURRENT] references following documents:

Document number Edition Title
ISO 9000 2015-09 Quality management systems - Fundamentals and vocabulary More 
DIN EN ISO 10012 2004-03 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 More 
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 14644-13 2017-11 Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017); German version EN ISO 14644-13:2017 More 
DIN EN ISO 14644-14 2017-01 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016); German version EN ISO 14644-14:2016 More 
DIN EN ISO 14644-15 2018-03 Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017); German version EN ISO 14644-15:2017 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