CE-024 Essential Principles (EP) Checklist 基本原则清单.docx

Essential Principles Checklist Identity of IVD medical device: Blood glucose monitoring system（URIT-25、URIT-26、URIT-28）Essential PrincipleApplicable to the device?Method Used to Demonstrate ConformityMethod ReferenceReference to Supporting Controlled Documents AGeneral RequirementsMedical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training, and the medical and physical conditions of intended users, they will perform as intended