Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2 : Revision to 4.3.4 and 11.2 - Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux - Amendement 2
€65.33
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 - Document d'orientation sur les aspects d'une approche, fondée sur l'appréciation du risque, permettant d'assurer la stérilité des produits de santé à usage unique, soumis à une stérilisation terminale y compris ceux ne pouvant pas supporter un traitement atteignant un niveau d'assurance de la
€107.33
Sterilization of health care products - Biological indicators - Part 7 : guidance for the selection, use and interpretation of results
€149.00
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Stérilisation des produits de santé - Vocabulaire - Termes utilisés dans les normes de procédés de stérilisation et les équipements connexes
€115.12
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
€78.00
Health care institutions - Controlled environment areas - Requirements for airborne contamination control - Établissements de santé
€156.67
Aseptic processing of health care products - Part 2 : filtration
Aseptic processing of health care products - Part 1 : general requirements
€134.67
Aseptic processing of health care products - Part 5 : sterilization in place
€83.67
Aseptic processing of health care products - Part 3 : lyophilization
€71.00
Aseptic processing of health care products - Part 4 : clean-in-place technologies
€83.50
Sterilization of health care products - Chemical indicators - Part 1 : general requirements - Stérilisation des produits de santé
€84.02
Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices - Stérilisation des produits de santé
€50.67
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
€47.00
Manufacture of cell-based health care products — Control of microbial risks during processing
€183.00
