1、醫療器械的產品生命周期管理(PLM).53Jo?G?4?Jl2009?X15?X8?PVol.15No.8?1?StandardandTesting?i?(1006-6586(2009)08-0053-03?G?9?(R197.323?H?1?.?(A?w?U?P?(2009-06-22?0?(?v?f?N?4?9?N?o?V?21?i?t?N?i?U?J.?O?P?&?v?V?h?iJ5?4?w?u?N?2?.?(?b?&?(?S?3?i?5?K?J5?v?&?V?w?u?.?O?N?(?O?P?i?n?V?N?e?n?X?8?9?4?J5?4?O?K?S?J.?N?

2、e?gJ5?N?4?.?(?J.?d?6J5?P?P?9(ProductLifecycleManagement?N?PLM)?O?(?rJ.?J.?w?uJ.?H?t?S?J.?v?l?9?N?D?PJ.?P?J.?5?9?F?5?K?M?9?9?J5?H?d?(?G?N?K?P?.?(?9?J51?P?P?9(PLM)?1.1PLM?P?P?P?9PLM?P?O?w?u?(?J.?c?aJ.?M?4?P?4?iJ5?p?N?O?5?K?C?J?K?5?K?K?.?3?5?K?)?O?v?h?i?K?N?P?a?N?i?(?N?5?K?P?)?V?O?h?O?P?n?K?4?n?9?)?O?P

3、?P?D?N?S?d?:?5?K?D?J?8?K?J5?J?OPLM?P?P?P?9?K?(PLM?O?N?p?O?.?p?k?9J.?v?w?P?P?G?&?V?N?J51.2PLM?H?h?4?P?P?9(PLM)?&1?v?f21?.?4?&(?210012)2?o?V?(?o?200030)?(?P?P?9(PLM)?O?.?(?M?v?i?S?J5PLM?V?4?(?(?S?N?4?N?.?(?9?O?b?N?(?w?J5?H?(?4?P?P?P?9?TheApplicationofProductLifecycleManagementtotheMedicalD

4、eviceIndustryXINGHong-suo1HONGXiao-ming21JiangsuMedicalDeviceTestingDepartment(Nanjing210012)2ShanghaiHaiheBusinessConsultingCorporation(Shanghai200030)Abstract:ProductLifecyclemanagementisaconceptualframeworkforanorganizationtoregulateandmanageaproductorservice.PLMsystemscanfacilitateandcontrolthes

5、haringofdeviceinformationwithintheorganization,whichisverycomplicatedsinceallthestakeholdersareinvolved.AndthusPLMsystemscanoptimizetheef?.encyofinformation,processanddecision-making,andcompanieswillbene?.t.Keywords:medicaldevice,PLM,productdevelopment.54Jo?G?4?Jl2009?X15?X8?PVol.15No.8?1?Standardan

6、dTestinguLPLM?.?(?6?r?N?0?J.?J5uLPLM?.?(?P?J?&?V?w?J5uLPLM?9?O?J5uLPLM?O?(?O?P?P?l?G?N?J.?w?u?9J5uLPLM?g?O?O?.?N?.?(?v?&?O?.J51.3?4?(?PLM?4?(?w?u?(?K?4J5?4?j?O?1?uR?u7?JuR?u7?v?lJ5?w?u?N?P?9?O?v?5?K?l?N?J?e?t?N?J?P?w?u?N?w?t?5?K?N?p?N?t?J?(?1)J5?o?v?w?J?J.?h?J.?D?n?XJ5?N?d?4?(?p21?i?P?N?n?n?

7、j?7?P?K?4?d?J.?O?I?w?u?(?J5?d?1?D?p?O?N?9?M?P?P?9J.?k?9CRM?9SCM?2?N?.?(?9?M?b?J52PLM?t?4?2.1?O?.?(?,?0?R?J5?O?5?K?K?(?J?w?uJ.?H?K?g?4?J5?O?4?N?&?V?c?HJ5?y?O?N?J.?M?w?u?J5?w?0?(uL?w?0?r?N?Ku60u-?w?N?O?K?P?p?l?O?J5?N?0?O?5?K?1?JJ5uL?w?1?N?p?w?1?5?K?J.?P?J?2?1?V?N?V?v?i?v?J5uL?w?2?N?0?N?9?J5?7?P?J5

8、uL?w?3?N?0?G?v?w?u?i?K?J.?i?G?O?w?u?J5uL?w?4?N?0?(?v?P?X?JJ5?O?m?k?H?k?J5?h?h?N?O?m?l?J5uL?w?5?P?O?N?p?P?w?u?J5?O?p?P?G?J5?n?n?K?z?P?J52.2?4?tPLM?S?O?h?O?a?4?w?u?N?h?S?h?V?hJ5?N?N?w?u?K?h?N?.?N?y?O?S?m?8?i?l?m?jJ5?1?(?D?pPLM?O?6?i?N?V?n?J5?O?v?l?S?N?N?e?D?p?&?V?D?J5PLM?p?2?v?w?2?v?J5?N?e?(?NPLM?

9、N?N?(?B?(PreventiveActions)?N?S?O?(CorrectiveActions)J5?j?p?N?h?h?d?w?u?jJ5?1?4?P?P.55Jo?G?4?Jl2009?X15?X8?PVol.15No.8?1?StandardandTesting?N?P?J5?(?N?H?P?l?w?J5?t?N?P?p?l?n?l?P?lJ5?S?8?N?-?B?,?i?0?P?lJ5?VTPLC?9?N?G?&?V?r?P?N?V?k?N?P?l?8?P?l?P?9?J5?K?4?4?N?w?u?l?2?v?J5?O?2?v?p?2?N?(?v?.?(?4?9?J5

10、?d?e?J?J5?v?l?8?1?,?N?h?J.?i?0?n?X?N?J?&?V?,?J.?S?m?8?J.?B?(CAPA)J5?V?p?k?PLM?G?N?l?8?J?P?O?.?,?4?J53PLM?t?4?H?t?9?93.1?4?H?t?9?(?z?d?4?.?(?w?u?l?N?N?p?lJ5?N?4?p?w?o?p?&?h?D?K?(J5?N?p?O?O?.?l?N?V?4?w?u?d?p?k?2?S?N?(?S?)?u?(?N?V?(?(?H?&?D?J5?I?K?h?N?NPLM?(?K?h?9?8?k?9?N?4?H?t?S?h?O?.?s?N?

11、K?k?6?p?J53.2?PLM?5?K?o?VPLM?J5?w?u?D?p?p?w?J5?l?O?P?K?)?u?h?9?V?ueue?k?J.?l?J.?CAD?J5?w?u?w?V?J?N?P?)?N?w?h?d?6J5?N?t?3?P?J5?K?9PLM?p?V?8?N?3?l?9?(?j?9?)?l?8?e?l?)?p?l?8?i?)?P?l?8?3?l?(?)?p?l?8?J?)?k?9?J?)?S?5?)IT?9?8?O?.J.?)?4?l?8?9?J?D?e?P?J54?4?P?i?o?(?4?J5?O?4?t?V?h?S?N?N?K?V?T?D?N?X?V?d?,?J5?N

12、?S?O?4?w?u?O?U?4?&?h?d?6J5?V?h?P?p?P?D?e?P?P?.?(?J?D?P?P?P?9J.?.?(?M?9J.?9?S?e?p?N?V?4?(?(?S?N?4?5?K?P?N?.?(?9?O?b?(?w?J5?i?N?.?(?PLM?H?d?4?N?d?4?h?V?hJ5?3?H1FDA,CriticalPathOpportunitiesReportR,March20062?J?v?,?PLM?6?M,?G?F?N20073KarlT.Ulrich,ProductDesignandDevelopmentM,fourthedition,?R?g?L?h?F,20084?v?,?.?V,?4?p?t?c?a?J.?G?4?.2006,30(2):120-122,1335?,?6?,?,?4?1?n?t?p?J,?G?4?1,2008,23(4):9-126SteveLane,Designing