Glossary:TAG-00208-Dev-ers

Glossary > Device deficiency

Device deficiency
Tag-ID	TAG-00208-Dev-ers
English	Device deficiency / Device malfunction / Device failure
French	Défectuosité d'un dispositif / Dysfonctionnement du dispositif
German	Produktmangel / Produktversagen / Gerätefehlfunktion

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 1-2	MD	Article 80 Paragraph 1-2	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1	MD	3.1	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19	MD	3.19	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33	MD	3.33	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52	MD	3.52	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001	MD	7.4.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002	MD	7.4.3	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5)	MD	§ 812.140 (b) (5)	EN	USA 21 CFR Part 812 09-Apr-2025