Steriilselt pakendatuna turule toodav meditsiiniseade tuleb projekteerida, toota ja pakendada ühekordseks kasutamiseks mõeldud pakendisse selliselt, et see oleks steriilne turule toomisel ning jääks steriilseks tootja kavandatud ladustamise ja transpordi tingimustes kuni kaitsepakendi avamiseni.
Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.
