NA 063

DIN Standards Committee Medicine

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Projects of NA 063

Number: 297

DIN CEN ISO/TS 11137-4 2022-11-24 Sterilization of health care products - Radiation - Part 4: Guidance on process control More  Comment 
DIN EN ISO 13004 2022-11-21 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD More  Comment 
DIN EN ISO 17664-2 2022-11-17 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices More  Comment 
DIN EN ISO 8871-5 rev 2022-11-03 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing More  Comment 
ISO/AWI TS 18701 2022-10-20 Molecular in vitro diagnostic examinations - Specificationsfor pre-examination processes for human specimens - Isolated microbiome DNA More  Comment 
ISO/AWI TS 18702 2022-10-20 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins More  Comment 
ISO/AWI 18703 2022-10-20 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma More  Comment 
ISO/AWI 18704 2022-10-20 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA More  Comment 
ISO/CD TS 23148 2022-10-17 Additional lubricants for male synthetic condoms - Effect on condom strength More  Comment 
DIN 58942-5 2022-10-14 Medical microbiology - Culture media - Part 5: Requirements and selection of culture media for the diagnostic of stool specimen More  Comment 

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