IVD 产品CE 认证基本要求检查表.doc

Annex IEssential Requirementsaccording to Directive 98/79/EC, on in vitro diagnostic medical devicesDevice:Trademark:Manufacturer:Distributor:Accessories:Drafted by:Date: Reviewed by:Date:Approved by:Date:Essential Requirements acc. to Annex Iof the IVDD (98/79/EC)A/ NAStandards, other directives and other rules applied by manufacturerDocumentation (test reports, protocols, literature or reason for nonapplicability)Ok / FailAnnex 1_IVDD, Rev. 0 Page 2 of 11A.GENERAL REQUIREMENTS1.The device must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art..In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:- eliminate or reduce risks as far as possible (inherently safe design and construction) - where appropriate take adequate protection measures including alarms if necessary, in relation to risks that can not be eliminated. - inform users of the residual risks due to shortcomings of the protection measures adopted.3.The devices must be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1(2)(b), as specified by the manufacturer, taking account of the generally acknowledged state of the art. They must achieve the performances, in particular, where appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer.The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order.4.The characteristics and performance referred to in sections 1 and 3 must not be adversely affected to such a degree that the health or the safety of the patients or the user and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use. When no lifetime is stated, the same applies for the lifetime reasonably to be expected of a device of that kind, having regard to the intended purpose and the anticipated use of the device.Essential Requirements acc. to Annex Iof the IVDD (98/79/EC)A/ NAStandards, other directives and other rules applied by manufacturerDocumentation (test reports, protocols, literature or reason for nonapplicability)Ok / FailAnnex 1_IVDD, Rev. 0 Page 3 of 115.The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage (temperature, humidity, etc.) taking into account the instructions and information provided by the manufacturer.B.DESIGN AND MANUFACTURING REQUIREMENTS1.1.1Chemical and PhysicalThe devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in Section A on the “General Requirements“. Particular attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials and the specimens (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.1.2The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by product leakage, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the product.2.2.1Infection and microbial contaminationThe devices and their manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of, a。