A collection of featured documents from our library that are popular among our users or otherwise noteworthy.
Clinical investigation of medical devices for human subjects -- General requirements
Clinical investigation of medical devices for human subjects -- Clinical investigation plans
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
Geometrical product specifications (GPS). Inspection by measurement of workpieces and measuring equipment -- Decision rules for verifying conformity or nonconformity with specifications
Non-active surgical implants. Implants for Osteosynthesis. Particular requirements
Non-active surgical implants. General requirements
Cleanrooms and associated controlled environments -- Classification of air cleanliness
Cleanrooms and associated controlled environments -- Part 10: Classification of surface cleanliness by chemical concentration
Cleanrooms and associated controlled environments -- Assessment of suitability for use of equipment by airborne particle concentration
Cleanrooms and associated controlled environments -- Energy efficiency in cleanrooms and separative devices
Cleanrooms and associated controlled environments -- Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Cleanrooms and associated controlled environments -- Test methods
Cleanrooms and associated controlled environments -- Design, construction and start-up
Cleanrooms and associated controlled environments.Design, construction and start-up.
Cleanrooms and associated controlled environments -- Operations
Cleanrooms and associated controlled environments -- Vocabulary
Cleanrooms and associated controlled environments -- Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Cleanrooms and associated controlled environments -- Assessment of air cleanliness by chemical concentration (ACC)
Cleanrooms and associated controlled environments -- Assessment of surface cleanliness for particle concentration
Cleanrooms and associated controlled environments. Assessment of surface cleanliness for particle concentration.
Geometrical product specifications (GPS). Geometrical features -- General terms and definitions
Cleanrooms and associated controlled environments. Biocontamination control -- General principles and methods
Cleanrooms and associated controlled environments. Biocontamination control -- Evaluation and interpretation of biocontamination data
Implants for surgery. Active implantable medical devices -- Implantable neurostimulators
Ophthalmic optics. Contact lens care products. Antimicrobial preservative efficacy testing and guidance on determining discard date