CE 0001地 医疗器械指令及CE认证概述.docVIP

CE — 0001 ò?á??÷Dμ??á??°CEè??¤??ê? 1. ?·???ˉ?±?á3é?±1ú?ééü ???°?·???ˉ?±?á1?2?á?°?ò?á??÷Dμ??á? (MDD) oíóD?′?2 è?D?ò?á??÷Dμ??á? (AIMD)×a???a±?1ú·¨1?μ?19??3é?±1ú??μ￥: 1. °?μ?à? 2. ±èà?ê± 3. μ¤?ó 4. ·òà? 5. ·¨1ú 6. μ?1ú 7. ?￡à° 8. ±ùμo 9. °???à? 10. òa′óà? 11. ??é-±¤ 12. oéà? 13. ?2ít 14. ??ì??à 15. ?÷°à?à 16. èeê? 17. èeμ? 18. ó￠1ú 19. áD?§??ê?μ? 2.ò?á??÷Dμ??á? èy???·??ò?á??÷Dμ??á? óD?′?2è?D?ò?á??÷Dμ??á?￡¨90/385/EEC￡?AIMDD￡? 2éó?￡o 1990?ê6??20è? éúD§￡o ×?1993?ê1??1è??e 1y?é?ú￡o1993?ê1??1è???1994?ê12??31è? ò?á??÷Dμ??á?￡¨93/42/EEC￡?MDD￡? 2éó?￡o 1993?ê6??14è? éúD§￡o ×?1995?ê1??1è??e 1y?é?ú￡o1995?ê1??1è???1998?ê6??13è? êμ?éêòó?????ò?á??÷Dμ??á?￡¨98/79/EC, IVD￡? 1998?ê10??27è?·￠2?, 2000?ê6??7è??aê?éúD§ ò?á??÷Dμ??á?μ??ù±??á11 ì???1. ±???á?êêó?óúò?á??÷Dμoí?????t ì???2. 3é?±1ú±?D?±￡?¤ò?á??÷Dμ??óD?ú°2è?ê±2??ü±?í? ·?êD3?2￠í?è?ê1ó? ì???3. ò???°2è?μ?“?÷Dμ”ê????ú×?????I?D?ù±?òa?óμ?ò??÷ ì???4. ′?óDCE±ê??μ?ò?á??÷Dμ?é?ú?·???ú×?óéá÷í¨?￡ ì?êaμ?ì???￡¨????VIIIoíX￡??êDíרó??÷Dμoíáù′2?D??ó??÷Dμ±?ê1ó????TDè′?óDCE±ê?? ì???5. ·?o?D-μ÷±ê×?μ?ò?á??÷Dμ±?è??a?ú×??ù±?òa?ó ì???8. è?1?·￠??ò?á??÷Dμ2?°2è?μ??°￡?±￡ ?¤ ì????êDí?3??3é?±1ú2éè?DD?ˉ?￡ ì???9. ·?o?D??à??3ìDòó?2ú?·μ?·?àà￡¨????IX?D??3?μ?·?àà1??ò￡?óD1? ì???11. ò?á??÷Dμ±?D?í¨1y?3ò?3ìDò￡¨????II??VI?Dμ??ùê?￡?ò?±??¤?÷?ü??·?o??ù±?òa?ó ì???17. ·?o??ù±?òa?ó2￠í¨1yá??àó|μ?·?o?D??à??3ìDòμ?ò?á??÷Dμ±?D?′?óDCE±ê?? ??á??Dò?D?D?μ????? ·?àà￡o?ùò?μ?ò?á??÷Dμ?é·??a??àà￡??ù?Y1??ò￡?êü2?í?μ?·?o?D??à??3ìDò?§?? ò???￡-?÷Dμ ?ì o?×°??μ?′|àí ?÷DμD??ü1éè??ù±?òa?ó ?3D??÷DμDèìá1?óD1?°2è?oíD??üμ?áù′2êy?Y éú2úéìD豨??ê?1êoí?ú×ù?÷Dμê1ó?μ??-?é 3.CE±ê?? ??μ?CE±ê??μ?2??è 2??è1. ·??????÷Dμμ?ì?μ?￡?è·?¨?üê?·??ú??á?·??§?ú 2??è2. è·