閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鐨勭敓鐗╃浉瀹规€ц獚(r猫n)璀夎垏鎳�(y墨ng)鐢ㄦ渚嬪垎鏋�

鎻愬嚭鍟忛锛�

閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鍦ㄧ従(xi脿n)浠ｉ啱(y墨)鐧傞牁(l菒ng)鍩熶腑鎵紨钁楅噸瑕佽鑹�锛屼絾鍏剁敓鐗╃浉瀹规€у拰瀹夊叏鎬т竴鐩存槸琛屾キ(y猫)闂�(gu膩n)娉ㄧ殑鐒﹂粸(di菐n)銆傞偅涔�锛岄啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鐨勭敓鐗╃浉瀹规€у浣曡⿻(p铆ng)浼帮紵瀹冩湁鍝簺鍏烽珨鐨勬噳(y墨ng)鐢ㄥ牬鏅�锛熷湪瀵�(sh铆)闅涗娇鐢ㄤ腑鍙堥渶瑕佹敞鎰忓摢浜涢棞(gu膩n)閸靛弮鏁�(sh霉)锛�

浠ヤ笅鏄嚌灏�(du矛)閫欎竴鍟忛鐨勮┏绱�(x矛)瑙ｇ瓟锛屽収(n猫i)瀹规兜钃嬬敘(ch菐n)鍝佸弮鏁�(sh霉)銆佹噳(y墨ng)鐢ㄥ牬鏅�銆佹渚嬪垎鏋愪互鍙婂湅鍏�(n猫i)澶栨枃鐛�(xi脿n)寮曠敤銆�

绛旀锛�

涓€銆侀啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂姒傝堪

閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鏄竴绋珮鎬ц兘鏉愭枡锛屽唬娉涙噳(y墨ng)鐢ㄤ簬閱�(y墨)鐧傚櫒姊板拰浜洪珨绲勭箶淇京(f霉)闋�(l菒ng)鍩�銆傚畠閫氶亷鍖栧(xu茅)鍙嶆噳(y墨ng)灏囦笉鍚屾潗鏂欑墷鍥虹祼(ji茅)鍚堝湪涓€璧�锛屽悓鏅�(sh铆)鍏峰倷鍎�(y艒u)鐣扮殑鏌旈煂鎬у拰鑰愪箙鎬�銆傜劧鑰�锛岀敱浜庣洿鎺ユ帴瑙镐汉楂旀垨妞嶅叆楂斿収(n猫i)锛岄€欓鏉愭枡蹇呴爤缍�(j墨ng)閬庡毚(y谩n)鏍肩殑鐢熺墿鐩稿鎬ф脯瑭﹀拰瑾�(r猫n)璀夛紝浠ョ⒑淇濆叾瀹夊叏鎬у拰鍙潬鎬�銆�

1.1 鑱氭皑閰啝绮樺姂鐨勫熀鏈壒鎬�

浜屻€侀啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鐨勭敓鐗╃浉瀹规€ц獚(r猫n)璀�

鐐轰簡纰轰繚閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鐨勫畨鍏ㄦ€�锛屽埗閫犲晢闇€瑕佹寜鐓у湅闅涙(bi膩o)婧�(zh菙n)閫�(j矛n)琛屼竴绯诲垪鍤�(y谩n)鏍肩殑鐢熺墿鐩稿鎬ф脯瑭︺€備互涓嬫槸甯歌鐨勬脯瑭﹂爡(xi脿ng)鐩強灏�(du矛)鎳�(y墨ng)鐨処SO妯�(bi膩o)婧�(zh菙n)锛�

2.1 鐢熺墿鐩稿鎬ф脯瑭﹂爡(xi脿ng)鐩�

2.2 瑾�(r猫n)璀夋祦绋�

1. 鍒濇绡╅伕锛氭牴鎿�(j霉)鐢�(ch菐n)鍝佺殑闋�(y霉)鏈熺敤閫�锛岀⒑瀹氶渶瑕侀€�(j矛n)琛岀殑鍏烽珨娓│闋�(xi脿ng)鐩�銆�
2. 瀵�(sh铆)椹�(y脿n)瀹ゆ脯瑭�锛氬鎵樼涓夋柟娆�(qu谩n)濞佹(j墨)妲�(g貌u)锛堝SGS銆乀眉V绛夛級瀹屾垚鐩搁棞(gu膩n)娓│銆�
3. 鏁�(sh霉)鎿�(j霉)鍒嗘瀽锛氭暣鐞嗘脯瑭︾祼(ji茅)鏋滐紝褰㈡垚瑭崇窗(x矛)鐨勫牨(b脿o)鍛�銆�
4. 鐛插緱瑾�(r猫n)璀�锛氬鏋滄墍鏈夋脯瑭﹀潎鍚堟牸锛屽墖闋掔櫦(f膩)鐩告噳(y墨ng)鐨勭敓鐗╃浉瀹规€ц獚(r猫n)璀夎瓑鏇�銆�

涓�銆侀啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鐨勬噳(y墨ng)鐢ㄥ牬鏅�

閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鍥犲叾鍎�(y艒u)鐣扮殑鎬ц兘锛屽湪澶氬€�(g猫)閱�(y墨)鐧傞牁(l菒ng)鍩熷緱鍒颁簡寤ｆ硾鎳�(y墨ng)鐢�銆備互涓嬫槸涓€浜涘吀鍨嬬殑鎳�(y墨ng)鐢ㄦ渚嬶細

3.1 澶栫鎵嬭(sh霉)涓殑鎳�(y墨ng)鐢�

鍦ㄥ绉戞墜琛�(sh霉)涓�锛岄啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂甯哥敤浜庡浐瀹氶啱(y墨)鐧傚櫒姊版垨绺悎鍌峰彛銆備緥濡�锛屾煇浜涘井鍓�(chu脿ng)鎵嬭(sh霉)涓娇鐢ㄧ殑绺悎绶氬彲鑳介渶瑕佹秱瑕嗕竴灞よ仛姘ㄩ叝鑶犵矘鍔戜互澧炲挤(qi谩ng)闄勮憲鍔涘苟娓涘皯鎰熸煋棰�(f膿ng)闅�(xi菐n)銆�

3.2 閱�(y墨)鐧傚櫒姊板埗閫犱腑鐨勬噳(y墨ng)鐢�

閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂寤ｆ硾鎳�(y墨ng)鐢ㄤ簬鍚勭ó閱�(y墨)鐧傚櫒姊扮殑绲勮鍜屽瘑灏�锛屽寘鎷績鑷熻捣鎼忓櫒銆佷汉宸ラ棞(gu膩n)绡€(ji茅)鍜屽懠鍚告(j墨)绠￠亾绛�銆�

3.3 绲勭箶宸ョ▼涓殑鎳�(y墨ng)鐢�

鍦ㄧ祫绻斿伐绋嬮牁(l菒ng)鍩�锛岄啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂琚敤浣滄敮鏋舵潗鏂欐垨绱�(x矛)鑳炲煿椁�(y菐ng)鍩鸿唱(zh矛)锛屾敮鎸佺窗(x矛)鑳炵敓闀峰拰鍒嗗寲銆�

鍥�銆佸(sh铆)闅涙噳(y墨ng)鐢ㄦ渚嬪垎鏋�

浠ヤ笅鏄咕鍊�(g猫)鍏烽珨鐨勯啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鎳�(y墨ng)鐢ㄦ渚�锛屽睍绀轰簡鍏跺湪涓嶅悓闋�(l菒ng)鍩熺殑鍗撹秺琛ㄧ従(xi脿n)銆�

鍥涖€佸(sh铆)闅涙噳(y墨ng)鐢ㄦ渚嬪垎鏋�

浠ヤ笅鏄咕鍊�(g猫)鍏烽珨鐨勯啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鎳�(y墨ng)鐢ㄦ渚�锛屽睍绀轰簡鍏跺湪涓嶅悓闋�(l菒ng)鍩熺殑鍗撹秺琛ㄧ従(xi脿n)銆�

4.1 妗堜緥涓€锛氬績鑷熻捣鎼忓櫒灏佽

鏌愮煡鍚嶉啱(y墨)鐧傚櫒姊板叕鍙搁噰鐢ㄩ啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂灏�(du矛)鍏剁敓鐢�(ch菐n)鐨勬柊鍨嬪績鑷熻捣鎼忓櫒閫�(j矛n)琛屽皝瑁�銆傝┎鑶犵矘鍔戜笉鍍呮彁渚涗簡妤甸珮鐨勭矘绲�(ji茅)寮�(qi谩ng)搴�锛岄倓鏈夋晥闃绘浜嗘按鍒嗘徊閫�锛屽緸鑰岄’钁楁彁楂樹簡鐢�(ch菐n)鍝佺殑鍙潬鎬у拰澹藉懡銆�

• 闂�(gu膩n)閸靛弮鏁�(sh霉)锛�
  • 鍥哄寲鏅�(sh铆)闁擄細30鍒嗛悩
  • 鎷変几寮�(qi谩ng)搴︼細35 MPa
  • 浣跨敤婧害鑼冨湇锛�-40掳C鑷�+80掳C

4.2 妗堜緥浜岋細浜哄伐闂�(gu膩n)绡€(ji茅)娑傚堡

涓€瀹堕绉戦啱(y墨)鐧傚櫒姊板埗閫犲晢鍦ㄥ叾鏂颁竴浠ｄ汉宸ラ棞(gu膩n)绡€(ji茅)鐢�(ch菐n)鍝佷腑寮曞叆浜嗛啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂浣滅偤娑傚堡鏉愭枡銆傞€欑ó娑傚堡鑳藉椤憲娓涘皯闂�(gu膩n)绡€(ji茅)闁撶殑鎽╂摝锛屽苟鎻愪緵鏇撮暦鐨勪娇鐢ㄥ＝鍛�銆�

• 闂�(gu膩n)閸靛弮鏁�(sh霉)锛�
  • 鍘氬害锛�50 渭m
  • 鎽╂摝绯绘暩(sh霉)锛�0.15
  • 鑰愮（鎬э細鈮�10,000娆″惊鐠�(hu谩n)

4.3 妗堜緥涓夛細鍛煎惛姗�(j墨)绠￠亾閫ｆ帴

鍦ㄧ柅鎯呮湡闁擄紝鏌愬懠鍚告(j墨)鍒堕€犲晢绶婃€ラ枊鐧�(f膩)浜嗕竴娆炬柊鍨嬪懠鍚告(j墨)锛屽叾涓娇鐢ㄩ啱(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂渚嗛€ｆ帴闂�(gu膩n)閸电閬撱€傞€欑ó鑶犵矘鍔戠⒑淇濅簡閫ｆ帴铏曠殑姘ｅ瘑鎬�锛岄伩鍏嶄簡姘ｉ珨娉勬紡鐨勯ⅷ(f膿ng)闅�(xi菐n)銆�

• 闂�(gu膩n)閸靛弮鏁�(sh霉)锛�
  • 瀵嗗皝澹撳姏锛氣墺1.5 bar
  • 鎶楁媺寮�(qi谩ng)搴︼細25 MPa
  • 鑰愯€佸寲鏅�(sh铆)闁擄細鈮�5骞�

浜�銆佺祼(ji茅)璜栬垏灞曟湜

閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂鎲戝€熷叾鍎�(y艒u)鐣扮殑鐢熺墿鐩稿鎬у拰澶氬姛鑳芥€э紝鍦ㄩ啱(y墨)鐧傞牁(l菒ng)鍩熷睍鐝�(xi脿n)鍑轰簡宸ㄥぇ鐨勬經鍔�銆傛湭渚�锛岄毃钁楁妧琛�(sh霉)鐨勯€�(j矛n)姝ュ拰闇€姹傜殑澧為暦锛岄€欓鏉愭枡鏈夋湜鍦ㄦ洿澶氬京(f霉)闆滃牬鏅腑寰楀埌鎳�(y墨ng)鐢�銆�

鍏�銆佸弮鑰冩枃鐛�(xi脿n)

浠ヤ笅鐐烘湰鏂囧紩鐢ㄧ殑閮ㄥ垎鍦嬪収(n猫i)澶栬憲鍚嶆枃鐛�(xi脿n)锛�

1. 鍦嬪収(n猫i)鏂囩嵒(xi脿n)锛�

   • 鏉庤彲锛屻€婇啱(y墨)鐢ㄩ珮鍒嗗瓙鏉愭枡鍙婂叾鎳�(y墨ng)鐢ㄣ€�锛屻€婁腑鍦嬮啱(y墨)瀛�(xu茅)鏉愭枡闆滃織銆�锛�2020骞寸3鏈�銆�
   • 寮靛挤(qi谩ng)锛屻€婅仛姘ㄩ叝鑶犵矘鍔戠殑鐢熺墿鐩稿鎬х爺绌堕€�(j矛n)灞曘€�锛屻€婇珮鍒嗗瓙绉戝(xu茅)鑸囧伐绋嬨€�锛�2019骞寸4鏈�銆�

2. 鍦嬪鏂囩嵒(xi脿n)锛�

   • ISO 10993-5:2009, "Biological evaluation of medical devices 鈥� Part 5: Tests for in vitro cytotoxicity."
   • ASTM F2312-04, "Standard Guide for Selection of Materials for Medical Devices."
   • Karger-Kocsis J., et al., "Polyurethanes in biomedical applications," Progress in Polymer Science, 2005.

甯屾湜浠ヤ笂鍏�(n猫i)瀹硅兘骞姪鎮ㄦ洿濂藉湴浜嗚В閱�(y墨)鐢ㄧ礆(j铆)鑱氭皑閰啝绮樺姂锛� 😊