Prikazano 61-80 od 119 stavki.
Oznaka standardaFaza izradeBAS/TCDatum realizacijePredviđeni datum naredne faze
  
prBAS EN ISO 11607-1/A1:2025
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 11607-2/A1:2025
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 11979-7:2025
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 12417-1:2025
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 13408-1:2025
Aseptic processing of health care products - Part 1: General requirements 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 15002:2025
Flow control devices for connection to a medical gas supply system 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 15098:2025
Dentistry - Dental tweezers 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 16021:2025
Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 16571:2025
Systems for evacuation of plume generated by medical devices 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 17664-2:2025
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 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 17665:2025
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 18113-1:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 18113-2:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 18113-3:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 18113-4:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 18113-5:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 20342-5:2025
Assistive products for tissue integrity when lying down - Part 5: Test method for resistance to cleaning and disinfection 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 20916:2025
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice 		10.99BAS/TC 2522.10.202412.03.2025
prBAS EN ISO 21535:2025
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants 		00.99BAS/TC 2508.10.202409.10.2024
prBAS EN ISO 21536:2025
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants 		00.99BAS/TC 2508.10.202409.10.2024