Polyetheretherketones (PEEK) 錛屼腑鏂囧悕縐頒負鑱氶啔閱氶叜錛屾槸鐢卞鑻簩閰氬拰4,4鈥?-浜屾盁浜岃嫰鐢查叜緇忚繃澶氭鍙嶅簲緙╄仛鑰屾垚鐨勪竴縐嶉珮鎬ц兘鑱氬悎鐗┿?
鑱氶啔閱氶叜涔嬫墍浠ヨ兘鍦ㄤ紬澶氬尰鐢ㄥ師鏉愭枡涓劚棰栬屽嚭錛屼笌鍏惰嚜韜殑鐗規у瘑涓嶅彲鍒嗕紭寮傜殑鐢熺墿鐩稿鎬?
鐢熺墿鐩稿鎬ф槸涓縐嶆潗鏂欐槸鍚﹂傜敤浜庢鍏ヤ綋鐨勬渶鍩烘湰鐨勮姹傘傛鍏ユ潗鏂欏繀欏繪棤緇嗚優姣掓с佽鍙樻с佽嚧鐧屾э紝涓斾笉鑷村紩鍙戣繃鏁忋傝耽鍒?Evonik)鍏徃鐨?VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰紝涓嶄粎鍦ㄥ浗澶栫嫭绔嬫祴璇曟満鏋?GLP瀹為獙瀹?涓ユ牸鎸夌収ISO10993鐨勮姹傚紑灞曠敓鐗╃浉瀹規ц瘯楠岋紝鑰屼笖鍦ㄤ腑鍥紺FDA鐩村睘鐨勩佸叿鏈夊縐戞鍏ョ墿鐢ㄨ仛閱氶啔閰叏欏圭洰媯嫻嬭祫鏍煎拰楠ㄧ鍖葷枟鍣ㄦ鍏ㄩ」鐩嫻嬭祫鏍肩殑媯嫻嬫満鏋勩佷弗鏍奸伒寰腑鍥藉浗鏍?GB16886鐨勮姹傝繘琛屼簡瀹屾暣鐨勭敓鐗╃浉瀹規ф祴璇曘傚浗鍐呭嫻嬭瘯鎶ュ憡鍧囪〃鏄庤耽鍒?Evonik)鐨?VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰叿鏈変紭寮傜殑鐢熺墿鐩稿鎬э紝娌℃湁浠諱綍鍓綔鐢ㄣ?
X灝勭嚎鍙┛閫忔?
鍜岄噾灞炵浉姣旓紝VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰彲琚玐灝勭嚎絀塊忥紝鍏鋒湁鑹ソ鐨勫彲瑙嗘э細1. 閬垮厤鍦╔鍏夌墖涓婇犳垚浼獎;2. 鍙互瀹炵幇鍦–T鎵弿鎴栨牳紓佸叡鎸垚鍍忚緟鍔╀笅榪涜鎵嬫湳錛屽府鍔╁尰鐢熷湪鎵嬫湳榪囩▼涓皟鏁存鍏ヤ綋鐨勪綅緗紝鏈悗杞繪澗璺熻釜鎰堝悎榪囩▼錛屼粠鑰岃兘瀵歸鐢熼暱鍜屾剤鍚堝疄鐜拌壇濂界殑鐩戞帶銆?
寮規фā閲忔洿鎺ヨ繎鐨川楠?
VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰垰鏌旂浉嫻庯紝寮規фā閲忎笌楠ㄩ鏇存帴榪戯紝鍙互鏈夋晥緙撹В搴斿姏閬斀鏁堝簲錛岄楠兼墍鍙楃殑搴斿姏騫朵笉瀹屽叏鐢辨鍏ヤ綋鎵挎媴錛屼嬌楠ㄩ鏇村仴搴楓佹洿闀夸箙銆?
鑷叾闂笘浠ユ潵錛孭EEK媧昏穬浜庡悇涓尰鐤楀櫒姊伴鍩熸闂磋瀺鍚堝櫒
濡傛灉鎮ｈ呮偅鏈夎剨鏌遍琛屾х梾鍙橈紝鍖葷敓涓鑸細寤鴻鍙栧嚭鐥呭彉鐨勬闂寸洏錛岀劧鍚庢鍏ヨ縐頒負鈥滄闂磋瀺鍚堝櫒鈥濈殑淇浣撴浛浠ｃ傝瀺鍚堝櫒琚涓哄湪鐩擱偦鐨勬楠ㄩ棿鎻愪緵涓縐嶉鎬ц繛鎺ワ紝铻嶅悎鍣ㄧ殑涓ぎ瀛斿唴鍙～鍏呯７閰擱挋鎴栨偅鑰呰嚜浣撻銆傛闂磋瀺鍚堝櫒澶氫負瑙ｅ墫鍨嬶紝鍏惰〃闈㈢殑閿嬌褰㈢粨鏋勬彁渚涗簡杈冮珮鐨勨滃垵濮嬬ǔ鍥烘р?鈥?涓縐嶄粎閫氳繃楠ㄥ唴縐嶆浣撶殑澶規寔鏁堝簲鑰岃幏寰楃殑紼沖浐鎬с?
闄や簡妞庨棿铻嶅悎鍣紝鐮旂┒鑰呬滑榪樺紑鍙慞EEK鍦ㄨ叞妞庣粡妞庡紦鏍硅灪閽夊姩鎬佸浐瀹氱郴緇熴佽叞妞庢紿侀棿妞嶅叆鐗╃郴緇熴佷漢宸ユ闂寸洏鍙婁漢宸ラ珦鏍哥瓑鑴婃煴棰嗗煙鐨勫垱鏂板簲鐢ㄣ?
緙濈嚎閾嗛拤
PEEK緙濈嚎閾嗛拤鍦ㄨ繍鍔ㄥ尰瀛︿腑寰楀埌浜嗗箍娉涘簲鐢紝鏈甯歌鐨勬槸鐢ㄤ簬娌葷枟鑲╄鎴栭煣甯︽挄瑁傛垨鍏跺畠鍏寵妭鍐呮崯浼ょ柧鐥呫傞噾灞炵紳綰塊搯閽夊鏄撳嚭鐜版澗鍔ㄣ佹嫈鍑哄拰杞鎹熶激鐨勫茍鍙戠棁銆傞珮寮哄害緙濈嚎鐨勫嚭鐜板鍔犱簡緙濈嚎閾嗛拤緇撳悎澶勭殑璐熻嵎錛屼粠鑰屽鍔犱簡緇撳悎澶勫垏鍓茬殑椋庨櫓銆傝孭EEK緙濈嚎閾嗛拤鍙互閬垮厤榪欎簺闂鐨勪駭鐢?鍚屾椂涓庡彲鍚告敹閾嗛拤鐩告瘮錛孭EEK鍏鋒湁鏇撮珮鐨勫己搴︺?
棰呴闈㈠縐?
涓嶇鏄厛澶╂х己闄瘋繕鏄簨鏁呮垨鐤劇梾寮曞彂鐨勯楠ㄦ崯浼わ紝棰呴妞嶅叆浣撶敤浜庝繚鎶ゆ偅鑰呰剢寮辯殑澶ц剳銆傚緱鐩婁簬3D鎵弿鎶鏈紝鍦ㄨ綆楁満涓婄簿紜湴閲嶅緩棰呴鐨勪笁緇寸粨鏋勶紝鐒跺悗閫氳繃CNC鍒囧墛宸ヨ壓鐢熶駭鍑轟釜鎬у寲鐨勯楠ㄦ鍏ヤ綋銆?
瀵逛簬鎮ｈ呮潵璇達紝浠栦滑鏇村枩嬈㈣秴浣庣儹瀵兼ф潗鏂欙細褰撴偅鑰呭懆鍥寸殑鐜娓╁害鍙戠敓鍓х儓鐨勫彉鍖栨椂錛屼緥濡傦紝鍐鏃舵偅鑰呬粠娓╂殩鐨勫鍐呮潵鍒板瘨鍐風殑瀹ゅ錛岄挍鍒墮楠ㄦ澘鍑鴻壊鐨勫鐑т細浣挎偅鑰呮劅鍒扮柤鐥涘拰涓嶉傘?
VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰埗鎴愮殑棰呴闈㈡鍏ヤ綋宸茶幏寰桭DA 510(K)璁よ瘉銆?
鍙ｈ厰
PEEK鏉愭枡搴旂敤浜庡彛鑵旂妞嶇墮鐨勯厤浠訛紝渚嬪涓存椂鍩哄彴銆佹剤鍚堝附銆佹剤鍚堝熀鍙幫紝宸叉湁鍗佸騫淬傛嬈¤耽鍒涙帹鍑虹殑VESTAKEEP廬鐡峰寮哄瀷PEEK鏄笓涓哄彛鑵斾慨澶嶉鍩熻璁＄殑涓縐嶆柊鍨嬫潗鏂欍傚拰甯哥敤鐨勯噾灞炪佹哀鍖栭攩鍜屾哀鍖栭摑絳夋潗鏂欑浉姣旓紝鏈夊涓嬩紭鐐癸細CAD/CAM鍔犲伐榪囩▼涓紝1:1鍒囧壊錛屾棤闇鐑х粨錛屾洿鍔犵簿紜?瀵嗗害浣庯紝璐ㄨ交錛屾偅鑰呬僵鎴磋垝閫?璐ㄥ湴鏌斿拰錛屽姣忔鍜悎璧峰噺闇囦綔鐢?浼樿壇鐨勭敓鐗╃浉瀹規э紝涓嶄細閲婃斁鍑洪噾灞炴垨鍗曚綋絳変笌浜轟綋涓嶇浉瀹圭殑鐗╄川錛岄槻姝㈢墮榫堣繃鏁忓拰鐫鑹茬摲鏀規у悗鐨凱EEK鍙戝嚭鑷劧鐨勭櫧鑹插厜娉斤紝緹庤鑰愮敤銆?
妞嶅叆寮忎綋娑叉車
榪欐槸涓縐嶆鍏ュ瀷銆佺數姹犻┍鍔ㄧ殑娉碉紝灝嗚倽鑵規按鐥囨偅鑰呬綋鍐呰繃閲忕殑鑵規按榪愯緭鑷寵唨鑳憋紝鍐嶆帓鍑轟綋澶栥傛秷闄や紶緇熺┛鍒烘湳瀹氭湡絀垮埡緇欐偅鑰呭甫鏉ョ殑鐥涜嫤銆?
鑸屼笅紲炵粡鍒烘縺緋葷粺
VESTAKEEP廬妞嶅叆綰ц仛閱氶啔閰埗鎴愮殑鑸屼笅紲炵粡鍒烘縺緋葷粺宸查氳繃CE璁よ瘉錛岀敤浜庢不鐤楅樆濉炴х潯鐪犲懠鍚告殏鍋滅患鍚堢棁(OSA)銆傚湪緹庡浗鍜屾境澶у埄浜氳繘琛岀殑涓村簥璇曢獙涓紝緇濆ぇ澶氭暟鐨勬偅鑰呰〃鐜板嚭闃誨鎬х潯鐪犳殏鍋滄槑鏄句笅闄嶏紝鎮ｈ呯殑鐫＄湢璐ㄩ噺銆佺敓媧昏川閲忓拰鏁翠綋鍋ュ悍鐘跺喌鏄庢樉鏀瑰杽銆?
涓轟簡婊¤凍涓村簥涓婄殑鍚勭闇姹傦紝璧㈠垱闄嗙畫寮鍙戜簡澶氱VESTAKEEP廬妞嶅叆綰EEK鐨勮鐢熶駭鍝侊紝紜吀閽℃樉褰卞瀷PEEK鍜岀⒊綰ょ淮(CF)澧炲己鍨婸EEK錛屽茍涓庝竴浜涗笓涓哄尰鐤楀櫒姊版彁渚涙秱灞傛湇鍔＄殑鍏徃寮灞昉EEK娑傚眰鐮旂┒銆傜嫭绔嬫嫻嬫満鏋勭幇鏈夌殑嫻嬭瘯緇撴灉琛ㄦ槑錛歏ESTAKEEP廬妞嶅叆綰EEK鍏鋒湁鍑鴻壊鐨勬媺浼稿拰鍓垏寮哄害錛屼笌娑傚眰鐨勭粨鍚堥潪甯哥墷鍥猴紝婊¤凍FDA鐨勬墍鏈夌浉鍏寵姹傘傞殢鐫瀵筆EEK鎬ц兘鐮旂┒鐨勬繁鍏ヤ互鍙婁互PEEK涓哄熀紜鐨勮鐢熶駭鍝佺殑寮鍙戯紝PEEK鑱氬悎鐗╁湪鍖葷枟棰嗗煙鐨勫簲鐢ㄥ墠鏅笉鍙及閲忋?
