NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11737-2 [CURRENT] references following documents:

Document number Edition Title
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 14644-1 2015-12 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More 
ISO 14644-12 2018-08 Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration More 
ISO 14644-13 2017-06 Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications More 
ISO 14644-14 2016-09 Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration More 
ISO 14644-15 2017-10 Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration More 
ISO 14644-16 2019-05 Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices More 
ISO 14644-2 2015-12 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration More 
ISO 14644-3 2019-08 Cleanrooms and associated controlled environments - Part 3: Test methods More 
ISO 14644-5 2004-08 Cleanrooms and associated controlled environments - Part 5: Operations More