CE认证基本要求对照表.pdfVIP

Farstar(wuxi)MedicalequipmentCo.,LTD Vision1.0 1/29 EssentialRequirementofMDD93/42Annex Ⅰ（Including Directive 2007/47/EC） MONITOR DEVICE EssentialRequirementofMDD93/42Annex Ⅰ A/NA EvidenceofCompliance SupportDocumentationLocation （Including Directive 2007/47/EC） 适用/不适用 相关的证据 形成的文件及存放位置 Ⅰ Genenalrequirements一般要求 1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the-purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided thatany risks which may be associated with theiruse constituteacceptable riskswhen weighed againstthe benefitsto the patientandarecompatiblewithahighlevelofprotectionofhealthandsafety. Thisshallinclude: -reducing,as far aspossible,the risk of use error due to the ergonomic features of the device and the enviroment in which the device is intended to be used(design forpatitientsafety,)and -considerration of the technical knowledge,experience,educationand training and where applicable the medical and physical conditions of intend users(design for lay,professional,disabledorotherusers) `如果与器械的使用可能相关的任何危险同患者的受益相比是可以接受的，并 且同高度的健康和安全保护水平相适应，器械的设计和制造就必须使其在按 预定用途和条件下使用时，不会危及到患者的临床状况或安全，或者使用者 和其他人的安全和健康。 这些应该包括： -尽可能的减少由于错误使用人体工程学特点和设备用于的环境（病人安 全方面的设计）而引起的风险 -充分考虑技术知识、经验、教育和培训，还有可适用的医学的和物理的 CETechnical.DOC Farstar(wuxi)MedicalequipmentCo.,LTD Vision1.0 2/29 预期使用条件。 EssentialRequirementofMDD93/42Annex Ⅰ A/NA EvidenceofCompliance