ivd 产品ce 认证基本要求检查表.doc

Annex I
Essential Requirements
according to Directive 98/79/EC, on in vitro diagnostic medical devices
Device:
Trademark:
Manufacturer:
Distributor:
Accessories:
Drafted by: Date:
Reviewed by: Date:
Approved by: Date:
A.
GENERAL REQUIREMENTS
1.
The device must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will promise, 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 patible 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 ings 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.
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