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瀹為獙瀹よ祫璁綉

浣犲彲浼氳瘑鍒尰鐤楀櫒姊扮殑鈥滆韩浠借瘉鈥濓紵

瀹為獙瀹よ祫璁綉鏃堕棿:2019-04-28 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

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TAG鏍囩锛?鍖荤枟鍣ㄦ UDI 韬唤璇?/a>

鍛ㄦ墍鍛ㄧ煡锛岃韩浠借瘉锛屾槸涓€绉嶈瘉鏄庤韩浠界殑閲嶈鏂囦欢銆傞偅涔堬紝鍖荤枟鍣ㄦ鐨?ldquo;韬唤璇?rdquo;鏄粈涔堬紵濡備綍閴村埆锛熷張濡備綍鐩戠锛?/span>

浣犲彲浼氳瘑鍒尰鐤楀櫒姊扮殑鈥滆韩浠借瘉鈥濓紵

UDI浣滀负涓€绉嶅尰鐤楀櫒姊颁骇鍝佹爣璇嗭紝鑳藉鍖哄埆涓嶅悓鍥藉鍘傚晢鐢熶骇鐨勪笉鍚屽瀷鍙疯鏍肩殑浜у搧锛涜兘澶熻幏鍙栧尰鐤楀櫒姊版敞鍐岀浉鍏崇殑閮ㄥ垎淇℃伅锛涜兘澶熷湪鍖荤枟鍣ㄦ浜у搧涓婅繘琛屾爣璁帮紱鑳藉鍦ㄧ幇浠g鐞嗘妧鏈腑杩涜蹇€熸绱紱鑳藉瀵瑰嚭鍘傚拰閲囪喘鐨勪骇鍝佽繘琛屽尯鍒嗭紝鍖呮嫭鍦ㄤ笉鍚屾椂闂存鑾峰緱鐨勪骇鍝併€?/span>

浠€涔堟槸UDI鏍囪瘑锛?/span>

鍖荤枟鍣ㄦ鍞竴鏍囪瘑锛?/span>Unique Device Identification锛岀缉鍐?/span>UDI锛夋槸瀵瑰尰鐤楀櫒姊板湪鍏舵暣涓敓鍛藉懆鏈熻祴浜堢殑韬唤鏍囪瘑锛屾槸鍏跺湪浜у搧渚涘簲閾句腑鐨勫敮涓€“韬唤璇?rdquo;銆傚叏鐞冮噰鐢ㄧ粺涓€鐨勩€佹爣鍑嗙殑UDI鏈夊埄浜庢彁楂樹緵搴旈摼閫忔槑搴﹀拰杩愪綔鏁堢巼锛涙湁鍒╀簬闄嶄綆杩愯惀鎴愭湰锛涙湁鍒╀簬瀹炵幇淇℃伅鍏变韩涓庝氦鎹紱鏈夊埄浜庝笉鑹簨浠剁殑鐩戞帶鍜岄棶棰樹骇鍝佸彫鍥烇紝鎻愰珮鍖荤枟鏈嶅姟璐ㄩ噺锛屼繚闅滄偅鑰呭畨鍏ㄣ€?/span>

涓轰粈涔堣浣跨敤UDI瑙勫垯锛?/span>

UDI瑙勫垯鐨勫疄鏂芥爣蹇楃潃鍖荤枟鍣ㄦ鐩戠灏嗚繘鍏ュ彲杩芥函鐨勪俊鎭寲绠$悊鏂版椂浠o紝瀹屽杽鐨勬暟鎹簱婧簮绠$悊绯荤粺灏嗗疄鐜板揩閫熷畾浣嶃€佸揩閫熻窡韪€佸揩閫熷弽搴旓紝浼氬鍑哄彛浼佷笟閫犳垚娣辫繙褰卞搷锛屽瓨鍦ㄨ川閲忛闄╃殑浜у搧灏嗘洿瀹规槗琚窡韪洃鎺у拰鍙洖锛屽苟鑳戒娇浼佷笟鏇村ソ鐨勫畬鎴愭爣鍑嗗寲鐢熶骇鍜岃鑼冨寲鎺у埗锛屽缓绔嬩竴浣撳寲缁堢璐ㄩ噺杩芥函绠$悊鏈哄埗锛岃繍鐢ㄤ骇鍝佹暟鎹噰闆嗘妧鏈瓑鐜颁唬鎶€鏈墜娈垫彁鍗囦骇鍝佷俊鎭寲绠$悊姘村钩锛岃褰曠敓浜х墿璧勬姇鍏ャ€佽川閲忔娴嬨€佸姞宸ュ寘瑁呭強鍚勭敓浜х幆鑺傜殑璇︾粏淇℃伅銆?/span>

UDI鏍囪瘑鍦ㄥ悇鍥界殑杩涘睍

娆х洘锛?/span>Medical Device Directives Revision (2012) Article 24 瑙勫畾浜嗭紝闄ゅ畾鍒舵垨鐢ㄤ簬瀹為獙鐨勫尰鐤楀櫒姊伴兘闇€瑕佷娇鐢?/span>UDI绯荤粺銆?/span>

缇庡浗锛?/span>FDA Final Rule 24.09.13, FDA final Rule 瑕佹眰寤虹珛UDI鏍囪瘑鐨勫尰鐤楀櫒姊扮郴缁熴€?/span>

鍔犳嬁澶?/span>锛?/span> 渚濇嵁IMDRF鍙戝竷鐨?/span>UDI绯荤粺鎸囧崡瀹炴柦锛屾洿澶氱殑鏈夊叧鍔犳嬁澶?/span>UDI绯荤粺鐨勮鑼冩寚鍗楁鍦ㄤ笉鏂畬鍠勩€?/span>

涓浗锛氱洰鍓嶄腑鍥藉尰鐤楀櫒姊颁笟鐣岄兘寮虹儓鍛煎悂寤虹珛鍞竴鐨勫櫒姊版爣璇嗭紝鐩墠寰堝鍖婚櫌閲囩敤鐨勭紪鐮佹病鏈夐噰鐢ㄧ粺涓€鐨勬爣鍑嗭紝涔熸病鏈夊吋瀹圭殑鑰冭檻锛岃繖灏嗗鑷磋拷婧簮澶淬€佺淮淇拰瑙e喅瀹夊叏闅愭偅鏃剁殑鍥伴毦銆?/span>

瀹炴柦UDI瑙勫垯鐨勯毦鐐瑰湪浜?/span>

璐圭敤鏀嚭锛?/span>鏍规嵁EUcomed鍏充簬2020骞村墠浼佷笟UDI寤虹珛鎵€鑰楄垂鐨勮祫閲戣皟鐮旓紝鏁翠釜浜т笟浼拌鑰楄垂娑夊強10浜挎鍏冦€?/span>

鏍囪瘑鎶€鏈細浼犵粺鐨?/span>UDI鏍囪鏂瑰紡鍦ㄦ竻娲椼€佺伃鑿屻€佹秷姣掔殑鐜涓嬪鏄撴崯鍧忥紝杩涜€屽奖鍝嶄骇鍝佽瘑鍒€?/span>

鍋ュ叏娉曡锛?/span>鎴戝浗鐨?/span>UDI缂栫爜鏂规骞朵笉瀹屽杽锛岀洰鍓嶄粛鍦ㄦ鍦ㄨ繘琛屻€?/span>

绀句細璁ゅ悓锛?/span>寰堝鍖婚櫌鍙槸婊¤冻鍐呴儴闇€姹傦紝鍦ㄧ紪鐮佷笂娌℃湁閲囩敤缁熶竴鏍囧噯鐨勬剰璇嗐€傚緢澶氫紒涓氬拰鍖荤枟琛屼笟鏈璇嗗埌鍖荤枟鍣ㄦ杩芥函鍜岀淮淇紝杩欐牱涓€鏁翠釜瀹屾暣浣撶郴寤虹珛鐨勫繀瑕佹€с€?/span>

涓€绉嶅彲琛岀殑UDI鏍囪鏂规硶锛?/span>

婵€鍏夋爣璁板彲鑳介潪甯搁€傜敤浜庡尰鐤楄澶囬儴浠朵笂鐨?/span>UDI锛岀敋鑷宠兘澶熺敤浜庣粡娑傚眰澶勭悊杩囩殑閮ㄤ欢銆傛縺鍏変骇鐢熶竴涓案涔呯殑鏍囪锛屽彲浠ユ壙鍙楀弽澶嶆竻娲楀拰鐏弻杩囩▼銆傛縺鍏夊彲浠ヤ骇鐢熼珮鍒嗚鲸鐜囩殑灏忔垨澶嶆潅鐨勬爣璁般€備綔涓烘暟瀛楀彲缂栫▼绯荤粺锛屾縺鍏夋墦鏍囧彲浠ラ€傚簲涓嶅悓閮ㄤ欢鐨勫嚑浣曞舰鐘跺拰鏍囪绫诲瀷銆傝€屼笖锛屼竴鏃﹀繀瑕佺殑璁惧琚喘涔帮紝璇ヨ繃绋嬫槸蹇€熺殑骞朵笖鍙互闀挎湡鍦板叿鏈夋垚鏈晥鐩娿€?/span>

婵€鍏?/span>UDI鏍囪鐨勪紭鍔?/span>

姘镐箙鎬?/span>锛氭縺鍏?/span>UDI閫氳繃灏嗛珮姣斾緥鐨勫厜鑳借浆鍖栦负鐑噺锛屽湪鏍囪鍖哄煙鐣欎笅闅句互绉婚櫎鎴栫鏀圭殑鏍囪銆傚洜姝ゅ父瑙勬竻娲佽繃绋嬶紙鍗充究浣跨敤鑻涘埢鐨勬秷姣掑墏锛変篃涓嶄細鎹熷鐩存帴鏍囪銆傚彲閲嶅浣跨敤鐨勮澶囧湪甯歌鐏弻鐜涓嬩篃涓嶄細褰卞搷鍒版縺鍏夋爣璁扮殑娓呮櫚搴︺€?/span>

鏁板瓧鍖栧拰鐏垫椿鎬?/span>锛氭縺鍏夋墦鏍囩郴缁熸槸鏁板瓧鍙紪绋嬬殑锛屽彲浠ヨ交鏉惧畾鍒讹細

鈼?/span>璁惧鏍囪瘑绗︼紙DI锛?/span>- 鏍囪瘑璁惧鍜岃澶囨爣绛剧殑寮哄埗鎬у浐瀹氶儴鍒?/span>

鈼嗙敓浜ф爣璇嗙锛?/span>PI锛?/span> - 鏈夋潯浠剁殑锛屽彲鍙樼殑閮ㄥ垎锛岃〃绀烘壒鍙峰拰鍒版湡鏃ユ湡绛夋暟鎹?/span>

鐩存帴鍦ㄨ澶囦笂鏍囪鐨?/span>UDI鍙互鏄互涓嬩袱绉嶆牸寮忎箣涓€/涓ょ锛?/span>

鈼忎汉绫诲彲璇?/span> - 瀹规槗闃呰锛岀函鏂囨湰鏍煎紡

鈼忔満鍣ㄥ彲璇?/span> - 鑳藉琚嚜鍔ㄨ瘑鍒拰鏁版嵁鎹曡幏鎶€鏈В閲?/span>

婵€鍏夋爣璁扮殑澶氬姛鑳芥€у彲浠ュ府鍔╁埗閫犲晢鑷敱鍦版牴鎹澶囩殑鍑犱綍褰㈢姸锛屽昂瀵稿拰琛ㄩ潰绾圭悊鍒涘缓绗﹀悎鏍囧噯鐨?/span>UDI鏍囪锛屽揩閫熸爣璁颁骇鍝佸苟灏嗗叾鍙戝竷鐢ㄤ簬鍟嗕笟鍖栥€傚熀浜庤蒋浠剁殑绯荤粺鍏佽鏍囪鐨勮澶囪繘琛屾暟瀛楃紪鐮侊紝骞跺皢鎵€鏈変俊鎭瓨鍌ㄥ湪鏁版嵁搴撲腑锛屼互渚胯繘琛屾湁鏁堢殑璺熻釜鍜岃皟鐢ㄣ€傚埗閫犲晢鍙互蹇€熼殧绂讳笌鐗瑰畾璁惧鐩稿叧鐨勬姤鍛婏紝浠ヨ瘑鍒换浣曟綔鍦ㄧ殑闂骞堕噰鍙栫籂姝f帾鏂姐€?/span>

楂樺垎杈ㄧ巼鍜屽噯纭€?/span>锛氬綋浣跨敤骞冲潶鐨勫浐瀹氱劍鐐规椂锛屾縺鍏夋墦鏍囨槸鏈€鏈夋晥鐨勶紝鑰岄潪骞冲潶琛ㄩ潰涔熷彲浠ヨ鎴愬姛鏍囪銆傚湪绗竴绉嶆儏鍐典笅锛屽垎杈ㄧ巼鍙互楂樿揪1000 dpi锛屾竻鏅扮殑鏂囧瓧鍙互灏忓埌0.5mm銆傚洜姝わ紝婵€鍏夋墦鏍囧彲浠ュ湪鐙皬鐨勭┖闂翠腑浜х敓澶嶆潅鐨勭粏鑺傘€?/span>

閫熷害鍜屾晥鐜?/span>锛氱敱浜庡啓鍏ラ€熷害楂樿揪2500mm/s锛屾縺鍏夋墦鏍囪繃绋嬪彲浠ュ府鍔╂彁楂樺悶鍚愰噺銆傜敱浜庢満鍣ㄤ笉浣跨敤鍖栧鍝佹垨婧跺墏锛屽洜姝ゅ埗閫犲晢鍙互閬垮厤鏀粯璐拱鍜屽偍瀛樼殑璐圭敤銆傛澶栵紝婵€鍏夋墦鏍囩郴缁熷彲浠ョ敱鍒堕€犲晢鍐呴儴浣跨敤锛屼娇鍏舵垚涓轰竴涓湁鏁堢殑杩囩▼銆?/span>

鎿嶄綔绠€鏄?/span>锛氫笌灏嗚创鐗囨垨鏍囩绮樿创鍒拌澶囦笂鐩告瘮锛屾縺鍏夋爣璁颁笉闇€瑕侀澶栫殑姝ラ鍜屾潗鏂欙紝渚嬪闇€瑕侀澶栫殑鍏煎鎬ц瘎浼扮殑鐗规畩鑳舵按鍜岀矘鍚堝墏鐨勫簲鐢ㄣ€傚彟澶栵紝鍦ㄥ櫒浠剁敓鍛藉懆鏈熶腑锛屾枒鍧楀拰鏍囩鍙兘浼氳劚钀姐€?/span>

鍐欏湪鏈€鍚?/span>

UDI璇嗗埆鐮佹閫愭鍦ㄤ笘鐣岃寖鍥村唴琚帴绾筹紝浣滀负鎻愰珮涓嶈壇鍙嶅簲浜嬩欢鐨勬姤鍛婅川閲忥紝鏄庣‘鍖绘偅绾犵悍鍜岀鐞嗗尰鐤楀櫒姊板垎閿€缃戠粶鐨勫埄鍣紝灏界瀵逛簬鍖荤枟鍣ㄦ鐢熶骇鍟嗘潵璇存姇鍏ラ澶э紝浣嗕笉鍙拷瑙嗙殑鏄紝鍏跺浜庣梾浜哄畨鍏ㄧ殑閲嶈淇濇姢鍜屽尰鐤楀櫒姊板浗闄呭寲鐨勭洃绠′紭鍖栧挨涓洪噸瑕併€?/span>

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TAG鏍囩锛?鍖荤枟鍣ㄦ UDI 韬唤璇?/a>
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