Module 15 2022

5/19/2022

Technical Documentation (Annex II)

• GSPR 1-9 – General requirements • GSPR 10-23 – Requirements regarding Design & Construction • GSPR 10 Chemical, physical and biological properties • GSPR 11 Infection and microbial contamination • GSPR 12 Devices incorporating medicinal substance or absorbed/locally dispersed • GSPR 13 Devices incorporating materials of biological origin • GSPR 14 Construction of devices and interaction with their environment • GSPR 15 Devices with a measuring function

13

© NAMSA 2021

13

Technical Documentation (Annex II)

• GSPR 10-23 (cont’d) Design & Construction • GSPR 16 Protection against radiation • GSPR 17 Electronic programmable systems

• GSPR 18 Active devices and devices connected to them • GSPR 19 Particular requirements for active implantable devices • GSPR 20 Protection against mechanical and thermal risks • GSPR 21 Protection against the risks posed to the patient or user by devices supplying energy or substances • GSPR 22 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons • GSPR 23 Label and instructions for use

14

© NAMSA 2021

14

7