CE024 Essential Principles (EP) Checklist 基本原则清单概要1.docxVIP

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 by the manufacturer and not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.YESRecognised standardEN ISO 14971:2012EN 61010-2-101:2002EN ISO 15197:2003CE-019CE-013CE-021The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. When risk reduction is required, the manufacturer should control the risks so that the residual risk associated with each hazard is judged acceptable. The manufacturer should apply the following principles in the priority order listed:identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;eliminate risks as far as reasonably practicable through inherently safe design and manufacture;reduce as far as reasonably practicable the remaining risks by taking adequate protection measures, including alarms; andinform users of any residual risks.YESRecognised standardEN ISO 14971:2012EN 61010-2-101:2002EN ISO 15197:2003EN 62366:2008EN ISO 18113-4:2011EN ISO 18113-5:2011CE-019-