NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 13485 [CURRENT] references following documents:

Document number Edition Title
ISO 14644-16 2019-05 Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices More 
ISO 14644-17 2021-02 Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications 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 
ISO 14644-7 2004-10 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) More 
ISO 14698-1 2003-09 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods More 
ISO 14698-2 2003-09 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data More 
ISO 14698-2 Technical Corrigendum 1 2004-11 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1 More 
ISO 19011 2018-07 Guidelines for auditing management systems More