Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices (Includes all amendments and changes 6/19/2024).
NORMA vydaná dňa 1.11.2023
Označenie normy: ASTM E3418-23e1
Dátum vydania normy: 1.11.2023
Počet strán: 22
Približná hmotnosť: 66 g (0.15 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Keywords:
acceptance limits, cleaning validation, HBEL, MSC, MSSR, risk-based, science-based, SPC,, ICS Number Code 11.040.01 (Medical equipment in general),11.080.20 (Disinfectants and antiseptics)