naSRPS EN 13795-1:2022

Hirurške obloge za jednokratnu upotrebu i višekratnu upotrebu, koje se koriste kao medicinski uređaji u zdravstvenim ustanovama, za pacijente, kliničko osoblje i opremu - Deo 1: Informacije koje treba dostaviti, zahtevi za proizvodnju i obradu i opšte smernice

Single use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 1: Information to be supplied, manufacturing and processing requirements and general guidance

Apstrakt

EN DRAPE-1 specifies information to be supplied in addition to the usual labelling of medical devices (see EN 980 and EN 1041) and manufacturing and processing requirements and gives general guidance for single-use and reusable coverings (i.e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures.

Povezane direktive

NAPOMENA: Ukoliko se u polju sa nazivom direktive ne nalazi reč „harmonizovan“ (obeležena zelenom bojom), to znači da evropski standard nije citiran u OJEU.