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心肺转流系统体外循环管道注册申报技术审查指导原则(2019年第78号)

FABUSHIJIAN:2022-03-02  LIULAN:CI

  附件:

心肺转流系统体外循环管道注册申报技术审查指导原则
(2019年第78号)

  BENZHIDAOYUANZEZHIZAIJICHUXINFEIZHUANLIUXITONG TIWAIXUNHUANGUANDAO(YIXIAJIANCHENGTIXUNGUANDAO)ZHUCEJUYOUZHIDAOYIYIDEZHINANXINGWENJIAN,YIFANGMIANYOULIYUJIANGUANBUMENDUITIXUNGUANDAOSHANGSHIQIANDEANQUANXINGHEYOUXIAOXINGJINXINGZHUNQUE、GAOXIAODEPINGJIA,LINGYIFANGMIANYOULIYUZHIDAOQIYEGUIFANCHANPINDEYANJIUHESHENGCHAN。

  BENZHIDAOYUANZEXIDUITIXUNGUANDAODEYIBANYAOQIU,ZHUCESHENQINGRENYINGYIJUCHANPINTEXINGDUIZHUCESHENBAOZILIAODENEIRONGJINXINGCHONGSHIHEXIHUA。ZHUCESHENQINGRENHAIYINGYIJUJUTICHANPINDETEXINGQUEDINGQIZHONGDEJUTINEIRONGSHIFOUSHIYONG,RUOBUSHIYONG,XUXIANGXICHANSHUQILIYOUJIXIANGYINGDEKEXUEYIJU。

  BENZHIDAOYUANZESHIDUIZHUCESHENQINGRENHESHENPINGRENYUANDEJISHUZHIDAOXINGWENJIAN,DANBUBAOKUOZHUCESHENPISUOSHEJIDEXINGZHENGSHIXIANG,YIBUZUOWEIFAGUIQIANGZHIZHIXING。RUGUOYOUNENGGOUMANZUXIANGGUANFAGUIYAOQIUDEQITAFANGFA,YEKEYICAIYONG,DANSHIXUYAOTIGONGXIANGXIDEYANJIUZILIAOHEYANZHENGZILIAO。YINGZAIZUNXUNXIANGGUANFAGUIDEQIANTIXIASHIYONGBENZHIDAOYUANZE。

  BENZHIDAOYUANZESHIZAIXIANXINGFAGUIHEBIAOZHUNTIXIYIJIDANGQIANRENZHISHUIPINGXIAZHIDINGDE,SUIZHEFAGUIHEBIAOZHUNDEBUDUANWANSHAN,YIJIKEXUEJISHUDEBUDUANFAZHAN,BENZHIDAOYUANZEXIANGGUANNEIRONGYEJIANGJINXINGSHISHIDEDIAOZHENG。

  一、适用范围

  BENZHIDAOYUANZESUOSHEJIDETIXUNGUANDAO,SHIZHISHIYUXINFEIZHUANLIUXITONG、YANGHEQIDENGPEITAOSHIYONGDETIWAIXUNHUANGUANDAO。TATONGCHANGYOUBENGGUAN、XUEYEGUANDAOHEQITABIYAODEPEIJIANZUCHENG,KEDAIYOUTUCENG,ANZHAOTIWAIXUNHUANDELINCHUANGCAOZUOGUIFANYONGYUXUYAOKAIZHANTIWAIXUNHUANZHUANLIUDEHUANZHE。BENZHIDAOYUANZEDETIXUNGUANDAOBUBAOHANQITAXUEGUANTONGLUQIXIE(RUDONGJINGMAICHAGUAN、YICIXINGSHIYONGXIYINGUAN、DONGMAIGUANLUXUEYEGUOLVQIDENG),YIJIYANGHEXUEYE、NONGSUOXUEYEDEYILIAOQIXIE。

  TIXUNGUANDAOYINGBAOZHENGTIWAIXUNHUANDECHANGTONGJITIGONGZUGOUDEXUEYELIULIANG,GENJUXUYAOKESHEYOUBIYAODEJIETOUHEFENLIUGUAN。GUANDAOXUTOUMING、GUANGHUA,QIEWUZHEHEN,BIMIANXUEYESHENLOUJIKONGQIJINRU。GEDUANKOUHELIANJIECHAKOUBIXUBAOZHENGLAOKAO,GUANGHUAWUMAOCI,YINGNENGYUGEPEIYONGZHUANGZHIDEJIEKOUJIANRONG,QIEYIYUPAIQI。BENZHIDAOYUANZESHIYONGYUKECHIXUSHIYONG6XIAOSHI,YIWUJUN、WUREYUANZHUANGTAITIGONGDEYICIXINGSHIYONGTIWAIXUNHUANGUANDAO。SHUYU《YILIAOQIXIEFENLEIMULU》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUGONGGAO2017NIANDI104HAO)ZHONG10SHUXUE、TOUXIHETIWAIXUNHUANQIXIEXIANGXIA06-06XINFEIZHUANLIUYONGGUANLUJIJIETOU。

  二、注册申报资料要求

  (YI)ZONGSHUZILIAO

  1.GAISHU

  CHANPINMINGCHENGYINGFUHE《YILIAOQIXIETONGYONGMINGCHENGMINGMINGGUIZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI19HAO)JIYOUGUANGUIDING。ANZHAODISANLEIYILIAOQIXIEGUANLI。

  2.CHANPINMIAOSHU

  MIAOSHUTIXUNGUANDAOGONGZUOYUANLI、JIEGOUZUCHENG、YUANCAILIAO,YIJIQUBIEYUQITATONGLEICHANPINDETEZHENGDENGNEIRONG;BIYAOSHITIGONGTUSHISHUOMING。

  3.XINGHAOGUIGE

  YINGDANGMINGQUEGEXINGHAOGUIGEDEQUBIE,DUIYUGEZHONGXINGHAOGUIGEDEJIEGOUZUCHENG、GONGNENG、TEZHENGDENGFANGMIANNEIRONGYINGJIAYIJUTIMIAOSHU。

  4.BAOZHUANGSHUOMING

  TIGONGYOUGUANTIXUNGUANDAOBAOZHUANGXIANGGUANDEXINXI,TEBIEYINGDANGZIXISHUOMINGYUMIEJUNFANGFAXIANGSHIYINGDEZUICHUBAOZHUANGDEXINXIYUZILIAO。

  5.SHIYONGFANWEIHEJINJIZHENG

  (1)SHIYONGFANWEI;

  (2)YUQISHIYONGHUANJING;

  (3)SHIYONGRENQUN:RUDUISHIYONGHUANZHEYOUTESHUYAOQIU,YINGZHUMING;

  (4)JINJIZHENG(RUSHIYONG)。

  6.CANKAODETONGLEICHANPINHUOQIANDAICHANPINDEQINGKUANG(RUYOU)

  YINGXIANGXISHUOMINGTONGLEIHUOQIANDAICHANPINGUONEIWAIYANJIUJILINCHUANGSHIYONGQINGKUANG。MIAOSHUBENCISHENBAOQIXIEYUYISHANGSHIQIXIE(BAOKUOBENQIYEYISHANGSHITONGLEICHANPINHUOQITAQIYEYISHANGSHITONGLEICHANPIN)DEXIANGTONGDIANHEBUTONGDIAN,BIJIAODEXIANGMUYIBAOKUOCHANPINSHEJI、SHIYONGFANWEI、GONGZUOYUANLI、JIEGOUZUCHENG、YUANCAILIAO、MIEJUNFANGSHI、XINGNENGZHIBIAO、YOUXIAOQIDENGNEIRONG,JIANYIYILIEBIAOFANGSHILIECHU。DUIYUTONGLEICHANPIN,YINGDANGSHUOMINGXUANZEQIZUOWEIYANFACANKAODEYUANYIN。

  7.YUANCAILIAOKONGZHI

  TIXUNGUANDAOYUANCAILIAOBUDERENWEITIANJIAYILIERUXIANGGUANFAGUIJIZHILINGJINZHIDE、HUOWEIJINGDULIXUEPINGGUDEWUZHI(RUYINGGUANGZENGBAIJIDENG),CHANGGUISHIYONGGUOCHENGZHONGBUDEDUIRENTICHANSHENGYOUHAIYINGXIANG。

  TIJIAOTIXUNGUANDAOSUOYOUZUJIANSHIYONGDEQUANBUZUCHENGCAILIAODEHUAXUEMINGCHENG、SHANGPINMING/CAILIAODAIHAO、ZUCHENGBILI、GONGYINGSHANGMINGCHENG、FUHEDEBIAOZHUNDENGJIBENXINXI。YINGMINGQUEMEIZHONGYUANCAILIAO,BAOKUOZENGSUJI、TESHUYUANCAILIAODEHUAXUETIANJIAWU、ZHANHEJIDENGWUZHI。JIANYITIGONGYUANCAILIAOSHENGWUXUEXINGNENGFUHEGB/T 16886.1《YILIAOQIXIESHENGWUXUEPINGJIA DI1BUFEN:FENGXIANGUANLIGUOCHENGZHONGDEPINGJIAYUSHIYAN》(ZHU:BENZHIDAOYUANZEZHONGBIAOZHUNSHIYONGYUZUIXINYOUXIAOBANBEN,XIATONG)HEYY 1048《XINFEIZHUANLIUXITONG TIWAIXUNHUANGUANDAO》DENGWENJIANYAOQIUDEPINGJIABAOGAO。DUIYUSHOUCIYONGYUTIXUNGUANDAODEXINCAILIAO,YINGTIGONGQISHIYONGRENTIYUQISHIYONGBUWEIDEXIANGGUANYANJIUZILIAO。

  YUANCAILIAO(HANWAIGOUZUJIAN)YINGJUYOUWENDINGDEGONGHUOQUDAO,TIGONGYUANCAILIAO(HANWAIGOUZUJIAN)SHENGCHANCHANGJIADEZIZHIZHENGMINGJIWAIGOUXIEYI。DUIYUSHENGCHANQIYEZIJIYANZHISHENGCHANDEYUANCAILIAOLILIAO,YINGTIGONGXIANGXIDEPEIFANGYANZHIBAOGAO,YIJIFUHEDEXIANGYINGBIAOZHUN。YUANCAILIAOCHANGJIANBIAOZHUNRUYY/T 0242《YIYONGSHUYE、SHUXUE、ZHUSHEQIJUYONGJUBINGXIZHUANYONGLIAO》、YY/T 0114《YIYONGSHUYE、SHUXUE、ZHUSHEQIJUYONGJUYIXIZHUANYONGLIAO》、YY/T 0806《YIYONGSHUYE、SHUXUE、ZHUSHEJIQITAYILIAOQIXIEYONGJUTANSUANZHIZHUANYONGLIAO》DENG。RUGUOSHENGCHANQIYESHIYONGDESHIWAIGOUCAILIAO,ZEYINGYAOQIUTIJIAOGAIYUANCAILIAOBIAOZHUNHEJIANCEWENJIAN,RUFUHESHANGSHUYUANCAILIAOBIAOZHUNDEJIANCEBAOGAO。TONGSHITIGONGSHENGCHANQIYEYUANCAILIAOYANSHOUBIAOZHUNHEBAOGAO。

  (ER)YANJIUZILIAO

  CONGJISHUCENGMIANLUNSHUSHENBAOCHANPINSHEJIYANZHENG、GONGYIYANZHENG,YIJIJISHUTEZHENG、SHENGCHANGONGYI、MIEJUNGONGYIYANJIU、YOUXIAOQIHEBAOZHUANGYANJIUDENGNEIRONG。ZHISHAOYINGBAOHANDANBUXIANYUYIXIANEIRONG:

  1.CHANPINXINGNENGYANJIU

  (1)SHEJITEZHENG

  YINGLIEMINGTIXUNGUANDAOGEBUJIANDEMINGCHENG、CAILIAO、JIEGOUHEGONGNENG,TIGONGTUYANG(DANGEBUJIANYUZONGZHUANGTU),NEIRONGYINGZUGOUXIANGJIN。TIJIAOGEBUJIANGONGNENGYUSHIXIANGONGNENGDEGONGZUOYUANLI、TUJINGYUJISHUZHIBIAODEZHIDINGYUYANZHENGDEXIANGXIMIAOSHU。RUCHANPINJUYOUTESHUJIEGOU、ZUJIAN、GONGNENGDENG,YINGTIGONGXIANGYINGJIEGOUTEZHENG、CANSHUHEXINGNENGFENXI,YIJIZHENDUIXINGSHEJIHEYANZHENGDENEIRONG。

  TIXUNGUANDAOSHEJIYANZHENGJIANYIBAOKUODUISHIYONGRENQUNSHENGLITEDIANDEFENXIYUYANZHENG,YIJIZHENDUIXINGSHEJISHUCHUDENEIRONG。LIECHUCHANPINBUJIANSUOSHIYONGQUANBUCAILIAO(BAOKUOZENGSUJI、ZHANHEJIDENG)MINGCHENG,YIBANBAOKUO:MEIGECAILIAODETONGYONGMINGCHENGYUZHUNQUEDEHUAXUEMINGCHENG、XUANYONGCAILIAOSHANGPINMING/CAILIAODAIHAO、SHIYONGSHICAILIAOZUCHENGBILI。YOUJIGAOFENZICAILIAOHAIYINGLIECHUQIFENZIJIEGOUSHI、PINGJUNFENZILIANG,JINSHUCAILIAOYINGLIECHUQIQUANBUJINSHUYUANSUMINGCHENG、BILIJIQIPAIHAO。

  (2)WULITEXING

  ①TIXUNGUANDAOGEZUJIANWAIGUAN、CHICUN、JIETOU、WUXIELOU、KEKAOLIANJIE、WEILISHULIANG、NAIWENXINGNENG、SHIYONGSHOUMING、LIULIANGDENGZHIBIAO。SUOYOUZUJIANYINGJUYOUGEZIXINGNENGYAOQIU。RUBAOHANTESHUZUJIAN、JIEGOU,YINGGUIDINGGAIZUJIAN、JIEGOUDECHICUN、XINGNENGYAOQIU。

  ②TUCENGTEXING

  RUCHANPINDAIYOUTUCENG,JIANYITIGONGTUCENGCHENGFEN、XINGNENGTEXING、WENDINGXINGHEANQUANXINGPINGJIADENGYAOQIUHEZHICHIXINGWENJIAN。

  (3)HUAXUEXINGNENGYAOQIU

  HAIYUANWUZHI、ZHONGJINSHU、SUANJIANDU、ZHENGFACANZHA、ZIWAIXIGUANGDU、SEZE、HUAXUEWUCANLIU(RUSHIYONG)DENG。

  (4)QITAXINGNENG

  WUJUN、XIJUNNEIDUSU、REYUANHEYOUXIAOQIDENG。

  (5)WUZHIRONGCHUJIANCE

  TIXUNGUANDAOKENENGHUIBAOHANZENGSUJI、TESHUYUANCAILIAODEHUAXUETIANJIAWU、ZHANHEJIDENGWUZHI。ZHEIXIEWUZHIJUYOUYIDINGQIANZAIDUXINGHUOXIANLIANGSHIYONG。WEIBAOZHENGCHANPINSHIYONGDEANQUANXING,JIANYIXUANZESHANGSHUWUZHIYONGLIANGZUIDADEXINGHAO,CAIYONGSHIYIJINTIRONGYE(RUXUEYETIDAIRONGJI、XUEYEDENG),MONILINCHUANGZUIYANGESHIYONGTIAOJIAN(RUCANKAOYY 1048《XINFEIZHUANLIUXITONG TIWAIXUNHUANGUANDAO》HUAXUEXINGNENGJIANYANYEZHIBEIGUIDINGFANGFA,SHUOMINGSHUTUIJIANDELINCHUANGSHIYONGZUIDA、ZUIXIAOXUEYELIULIANGXIA,37℃XUNHUAN6XIAOSHI),JIANCESHANGSHUWUZHIRONGCHUZONGLIANG。TIGONGRENTIXUEYEJIECHUZHEIXIEWUZHIDEDUXINGFENXI、ANQUANXIANZHIHELAIYUANWENJIAN,BINGZHENDUIBUTONGRENQUNSHENGLITEDIANFENBIEJINXINGANQUANXINGPINGJIA。

  2.SHENGWUXIANGRONGXINGPINGJIAYANJIU

  KECANKAOGB/T 16886.1HEYY 1048DENGWENJIANYAOQIU,DUIBAOHANQUANBUYUANCAILIAODEDIANXINGXINGXINGHAOKAIZHANSHENGWUXUEPINGJIA。

  3.SHENGWUANQUANXINGYANJIU

  RUTIXUNGUANDAOHANYOUDONGWUYUANXINGCAILIAOHUOSHENGWUHUOXINGWUZHIDENGCHENGFEN,RUSHENGWUTUCENG。CANKAO《DONGWUYUANXINGYILIAOQIXIECHANPINZHUCESHENBAOZILIAOZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI224HAO)DENGWENJIANDEYAOQIU,TIGONGXIANGGUANCAILIAOJISHENGWUHUOXINGWUZHIDESHENGWUANQUANXINGYANJIUZILIAODENGWENJIAN。BAOKUOSHUOMINGZUZHI、XIBAOHECAILIAODEHUOQU、JIAGONG、BAOCUN、CESHIHECHULIGUOCHENG;CHANSHULAIYUANBINGMIAOSHUSHENGCHANGUOCHENGZHONGDUIBINGDU、QITABINGYUANTIJIMIANYIYUANXINGWUZHIQUCHUHUOMIEHUOFANGFADEYANZHENGSHIYAN;GONGYIYANZHENGDENG。

  4.MIEJUNGONGYIYANJIU

  MINGQUECHANPINMIEJUNFANGFADEXUANZELIYOU,MINGQUEMIEJUNGONGYIHEWUJUNBAOZHENGSHUIPING,BINGTIGONGMIEJUNQUERENBAOGAO。MIEJUNGUOCHENGHAIYINGKAIZHANYIXIAFANGMIANDEQUEREN:CHANPINYUMIEJUNFANGFADESHIYINGXING、BAOZHUANGYUMIEJUNGONGYISHIYINGXING、MIEJUNYOUXIAOQIYANZHENGZILIAO、DUXINGWUZHICANLIULIANGYANJIUZILIAO。

  5.YOUXIAOQIHEBAOZHUANGYANJIU

  YOUXIAOQIYANZHENGXIANGMUBAOKUOCHANPINSHIYONGXINGNENGHEBAOZHUANGWANZHENGXING。KECAIYONGJIASULAOHUAHUOSHISHILAOHUADEYANJIU。SHISHILAOHUADEYANJIU,YINGCONGCHANPINDINGXINGHOUJIKAISHIJINXING。JIASULAOHUAYANJIUDEJUTIYAOQIUKECANKAOASTM F1980-16 《Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices》HEYY/T 0681.1《WUJUNYILIAOQIXIEBAOZHUANGSHIYANFANGFA DI1BUFEN:JIASULAOHUASHIYANZHINAN》。

  TIJIAOBAOZHUANGYANZHENGBAOGAO,RU:BAOZHUANGCAILIAODEWULIHUAXUE、DULIXUETEXING;BAOZHUANGCAILIAOYUCHANPINDESHIYINGXING;BAOZHUANGCAILIAOYUCHENGXINGHEMIFENGGUOCHENGDESHIYINGXING;BAOZHUANGCAILIAOSUONENGTIGONGDEWULI、HUAXUEHEWEISHENGWUPINGZHANGBAOHU;BAOZHUANGCAILIAOYUSHIYONGZHESHIYONGSHIDEYAOQIU(RUWUJUNKAIQI)DESHIYINGXING;BAOZHUANGCAILIAOYUBIAOQIANXITONGDESHIYINGXING;BAOZHUANGCAILIAOYUZHUCUNYUNSHUGUOCHENGDESHIYINGXINGDENG。

  6.LINCHUANGQIANDONGWUSHIYAN

  RUXUYAO,JIANYITIGONGDONGWUSHIYANDEWANZHENGZILIAO,YINGBAOKUO:

  (1)DONGWUSHIYANMUDE、MOXINGXUANZEDEYIJU;

  (2)YANJIUZHONGSHIYONGDEZHILIAOCANSHUYUJIANYIYONGYURENTIZHILIAOCANSHUDEBIJIAO;

  (3)SHIYANDANWEIHERENYUANZIZHI、SHIYANFANGAN、JIANYANFANGFAHESHEBEI;

  (4)JILUJIJIEGUO(BAOKUOYUANSHISHUJUYANGBEN);

  (5)JIELUN。

  (SAN)SHENGCHANZHIZAOXINXI

  YINGBAOHANCHANPINSHEJIGUOCHENGHESHENGCHANGONGYIGUOCHENGZILIAO,TEBIESHISHANGSHUTIXUNGUANDAODEXINGNENGZHIBIAO、ZHIBIAODEXUANZEYIJUYUYANZHENGZILIAO。KECAIYONGLIUCHENGTUDEXINGSHIGAISHUSHEJIGUOCHENGHESHENGCHANGUOCHENG。

  XIANGXISHUOMINGCHANPINSHENGCHANGONGYIGUOCHENGJIQIQUEDINGDEYIJU、ZHILIANGKONGZHIBIAOZHUNJIQIKEKAOXINGLUNZHENG;QUERENGUANJIANGONGYIDIANBINGCHANMINGQIDUICHANPINWULIXINGNENG、HUAXUEXINGNENG、SHENGWUXINGNENGDEYINGXIANG;QUERENSHENGCHANGONGYIDEWENDINGXING。DUISHENGCHANJIAGONGGUOCHENGSHIYONGDESUOYOUZHUJI、ZHANHEJIDENGTIANJIAJIJUNYINGSHUOMINGSHIYONGJILIANG、DUICANLIULIANGDEKONGZHICUOSHIHEJIESHOUBIAOZHUN,YIJIJIANYANBAOGAOHEANQUANXINGPINGJIABAOGAO。YOUDUOGEYANZHI、SHENGCHANCHANGDI,YINGDANGGAISHUMEIGEYANZHI、SHENGCHANCHANGDIDESHIJIQINGKUANG。

  (SI)LINCHUANGPINGJIAWENJIAN

  ANZHAO《YILIAOQIXIELINCHUANGPINGJIAJISHUZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2015NIANDI14HAO)GUIDINGGESHIHENEIRONG,TIGONGXIANGYINGLINCHUANGPINGJIAWENJIAN。

  如开展临床试验,应按照国家药品监督管理局相关规定,按照《医疗器械临床试验质量管理规范》(国家食品药品监督管理总局、中华人民共和国国家卫生和计划生育委员会令第25号)等文件的要求实施。申报资料中应提交伦理委员会批件、试验方案和临床试验报告等文件,建议提交统计分析报告。

  LINCHUANGSHIYANGENJUCHANPINSHENBAOYONGTU、SHIYANMUDEKAOLVNARUBINGZHONGHEYANZHONGCHENGDU,ZAISHIYANFANGANZHONGYINGXIANGXISHUOMINGRUXUAN/PAICHUBIAOZHUNYIJIZHONGZHISHIYANBIAOZHUN。

  1.LINCHUANGSHIYANJIBENYAOQIU

  SHIYANFANGANYINGMINGQUEYANJIUMUDE、YANJIURENQUN、GUANCHAZHIBIAO、DUIZHAOXUANZEJIYANJIUSHEJILEIXINGDENG。DUOZHONGXINLINCHUANGSHIYANYOUDUOWEIYANJIUZHEANZHAOTONGYISHIYANFANGANZAIBUTONGDELINCHUANGSHIYANJIGOUZHONGTONGQIJINXING。

  SHIYANPINHEDUIZHAOPINXUANZEYUANZE:

  申报产品选择试验品时,建议选择包含全部原材料和组件、功能最复杂、经过全项目注册检测的典型性型号进行临床试验。如进行随机对照试验,应详细描述对照品的规格型号、生产厂家和批号、对照品选择依据等。对照品应选择已经获得有效医疗器械注册证、有确切疗效和安全性的产品。对照品的原材料、性能结构、适用范围和使用方式等应尽量与试验品一致。试验组和对照组的试验条件、方法步骤、临床观察项目、评价依据等应相同。

  2.SHOUSHIZHERUXUANHEPAICHUBIAOZHUN

  (1)RUXUANBIAOZHUN

  ①SHIHEJINXINGTIWAIXUNHUANDEHUANZHE;

  ②NIANLING、XINGBIEBUXIAN;

  ③自愿参加并签署书面知情同意书。

  (2)PAICHUBIAOZHUN

  ①TONGSHISHIYONGQITALIAOFA,BINGDUIBENSHIYANPINGJIAYOUYINGXIANGDEHUANZHE;

  ②RENSHENJIBURUQIFUNV;

  ③HUANYOUYANZHONGPINXUE、GANRAN、ZHONGLIU、JIZHENHUANZHE、HUODONGCHUXUEHUONINGXUEGONGNENGYICHANG,YIJIYANZHONGDEGAN、SHENBINGHUANZHE;

  ④LUNEICHUXUEHUOLUNEIYAZENGGAOHUANZHE,YIJINANYIKONGZHIDEGAOXUEYA/DIXUEYAHUANZHE;

  ⑤YOUJINGSHENXINGJIBINGHUOBINGSHIZHE、XIDUZHE,HIV、MEIDU、YIGAN、BINGGANBINGDUYANGXINGHUANZHE;

  ⑥1GEYUENEICANJIAGUOQITALINCHUANGSHIYANZHE;

  ⑦GUOMINTIZHIHUANZHE;

  ⑧YANJIUZHERENWEIBUSHIHERUZUZHE。

  3.LINCHUANGGUANCHAZHIBIAO

  (1)ZHUYAOYOUXIAOXINGPINGJIAZHIBIAO:

  TIWAIXUNHUANCHENGGONGLV(CHENGGONGWANCHENGTIWAIXUNHUANGUOCHENGDEHUANZHESHUZHANQUANBUSHOUSHIHUANZHEDEBILI)。CHENGGONGWANCHENGTIWAIXUNHUANGUOCHENGDINGYIWEICHANPINTONGSHIMANZUYIXIAYAOQIU:

  ①TIXUNGUANDAOZHONGXUEYELIUDONGTONGCHANGWUDUSAI,XUELIULIANGMANZUTIWAIXUNHUANZHICHIDEYAOQIU;

  ②BENGGUANDANXINGLIANGHAO,NIANYAHOUKEYIFUYUAN,WUMINGXIANBIANXING;

  ③YUPEIYONGQIXIELIANJIELAOGU,GELIANJIECHUWULOUXUE、WULOUQI、WUTUOLUO。SHIYONGGUOCHENGZHONGGUANLUWUDAZHE、WULIEHEN、WUKAILIE。

  (2)CIYAOYOUXIAOXINGPINGJIAZHIBIAO:

  ①TIXUNGUANDAOWAIGUAN(ROURUANDU、TOUMINGDUHEGUANGJIEDU,SHIFOURONGYIGUANCHAQIPAO);

  ②QITAZUJIANXINGNENGSHIFOUMANZUSHIYONGYAOQIU。

  RUCHANPINXUANCHENGJUYOUTESHUGONGNENG,HUOZHEBAOHANTESHUZUJIAN,JIANYIJIANGGAIGONGNENGHUOZUJIANLIERUYOUXIAOXINGPINGJIAZHONG。

  (3)ANQUANXINGPINGJIAZHIBIAO:

  ①TIWAIXUNHUANKAISHIQIAN、KAISHIHOU15FENZHONG、TIWAIXUNHUANJIESHUJIKE、SHUHOUCIRIDEXUECHANGGUI(BAIXIBAO、HONGXIBAO、XUEHONGDANBAI、HONGXIBAOBIRONG、XUEXIAOBANJISHUDENG);

  ②TIWAIXUNHUANKAISHIQIAN、KAISHIHOU15FENZHONG、TIWAIXUNHUANJIESHUJIKESHIXUEQIXIANGMU,ZHISHAOBAOKUO:RUSUAN、SUANJIANDU、PO2、PCO2、JIANSHENGYUDENG;

  ③TIWAIXUNHUANQIAN、SHUHOUCIRIJIANCEXUEYESHENGHUAXIANGMU,ZHISHAOBAOKUO:BAIDANBAI、QIUDANBAI、BINGANSUANANJIZHUANYIMEI(ALT)、TIANMENDONGANSUANANJIZHUANYIMEI(AST)、XUENIAOSUDANHEJIGAN、CFANYINGDANBAI;

  ④TIWAIXUNHUANKAISHIQIAN、KAISHIHOU15FENZHONG、TIWAIXUNHUANJIESHUJIKESHITIWEN、HUXI、XUEYADENGSHENGMINGTIZHENGBIANHUA;

  ⑤TIWAIXUNHUANGUOCHENGZHONGJIJIESHUHOUBULIANGFANYING(RUPIZHEN、PIFUCHAOHONGDENG)DEFASHENGQINGKUANG。

  CAIXUESHIJIANDIANWEITIWAIXUNHUANKAISHIQIAN、KAISHIHOU15FENZHONG、TIWAIXUNHUANJIESHUJIKE、SHUHOUCIRI,ANZHAOTIWAIXUNHUANCAOZUOGUIFANDUIXUEBIAOBENLIUQUDEGUIDINGFANGFACAIJIXUEYANG。CEXUEQISHI,TIWAIXUNHUANKAISHIQIANYUDONGMAICEYAGUANCHOUQU(XUPAICHUKANGNINGYETI)DONGMAIXUE,KAISHIHOU15FENZHONG、TIWAIXUNHUANJIESHUJIKESHIYUTIXUNGUANDAODONGMAIDUANCAIYANGKOUCHUCAIJIXUEBIAOBEN。SHUHOUCIRIQUJINGMAIXUEJIANCEXUECHANGGUI、SHENGHUAGAN、SHENJININGXUEGONGNENGDENG。SUOYOULINCHUANGSHIYANJIGOUDECAIXUEFANGSHIYINGXIANGTONG。

  JILULINCHUANGSHIYANZHONGBULIANGSHIJIAN,BINGFENXIQIYUANYIN、HOUGUO,YIJIYUSHIYANCHANPINDEGUANXI。

  4.样本量

  YANGBENLIANGGENJUSHOUSHICHANPINDELINCHUANGSHIYANSHEJILEIXING、ZHUYAOPINGJIAZHIBIAODENGYINSULAIQUEDING。XUXIANGXIXIEMINGYANGBENLIANGGUSUANCAIYONGDERUANJIANHUOGONGSHI,YIJIGONGSHIZHONGDESUOYOUCANSHUJIQIGUJIZHI,HAIYINGJIEHELINCHUANGSHIJIQINGKUANGKAOLVSHIYANDUIXIANGDEKENENGTUOLUOLVDENGYINSU。DUIYUFEILIEXIAOSHIYANSHEJI,YINGYOULINCHUANGZHUANJIAHETONGJIXUEJIASHIXIANJICHUJUYOULINCHUANGYIYIDEFEILIEXIAOJIEZHI。DUIYUDANZUMUBIAOZHISHEJI,YIXUMINGQUEJICHUMUBIAOZHIQUEDINGDEHELIYIJU。

  YIXIAJULINEIRONGJINGONGCANKAO:

  如果某产品采用非劣效试验设计,预计主要有效性评价指标“体外循环成功率”为98%,假定被试产品疗效与对照产品疗效相当,当非劣效界值取5%,等比例入组分配,统计学检验水准取α=0.025(单侧),β=0.20(把握度取80%)。计算每组所需样本量为124例,两组共计248例。如果考虑到试验过程中约5%的病例脱落(含因严重违背方案而剔除的情况),试验纳入病例数应不低于260例。

  RUGUOCAIYONGDANZUMUBIAOZHISHEJI,JIADINGSHOUSHICHANPINZHUYAOYOUXIAOXINGPINGJIAZHIBIAO“TIWAIXUNHUANCHENGGONGLV”WEI98%,MUBIAOZHIWEI95%,TONGJIXUEJIANYANSHUIZHUNQUα=0.025(DANCE),β=0.20(BAWODUQU80%)。JISUANSUOXUYANGBENLIANGWEI331LI。ZAICIJICHUSHANGKAOLVYIDINGBILIDETUOLUOLV,ZUIZHONGDERUZUGUIMOQUEDINGWEI335LI。

  WEILEBAOZHENGSHOUSHIZHEDEANQUANXINGHESHUJUDEWANZHENGXING,JIANYIYOUTIAOJIANDECAIYONGJIYUHULIANWANGDEZHONGYANGSUIJIXITONGHUOZHONGYANGZHUCEDENGJIXITONG(DANZUMUBIAOZHISHEJI),YIBEIJIANGUANBUMENGENZONGJICHAQUANBUCANYUSHIYANBINGLI。

  5.LINCHUANGSHIYANTONGJIFENXIFANGFA

  SHUJUFENXISHIYINGKAOLVSHUJUWANZHENGXING,SUOYOUQIANSHUZHIQINGTONGYIBINGSHIYONGLESHOUSHICHANPINDESHIYANDUIXIANGBIXUNARUZUIZHONGDETONGJIFENXI。FENXISHOUSHIZHETUICHUHUOTUOLUODEYANZHONGCHENGDUHECHANSHENGYUANYIN。SHUJUTICHUHUOPIANYISHUJUDECHULIBIXUYOUKEXUEYIJUHEXIANGXISHUOMING,BINGYINGJINXINGLINGMINDUFENXI,YIPINGJIAQIDUIYANJIUJIEGUODEYINGXIANG。

  SHUJUFENXIYINGCAIYONGGUONEIWAIGONGRENDETONGJIRUANJIANHEFENXIFANGFA。SHIYANFANGANYINGMINGQUETONGJIJIANYANDELEIXING、JIANYANJIASHE、PANDINGLIAOXIAOYOULINCHUANGYIYIDEJIEZHI(FEILIEXIAOJIEZHI)DENG,JIEZHIDEQUEDINGYINGYOUYIJU。

  TUIDUANSHIYANCHANPINYOUXIAOXINGSHIFOUMANZULINCHUANGYINGYONGXUYAOSHI,BUNENGJINJIANGpZHIZUOWEIDUIZHUYAOYANJIUZHONGDIANJINXINGPINGJIADEYIJU。DUIYUSUIJIDUIZHAOSHIYANSHEJI,YINGJISUANZUJIANDABIAOLVCHASHUANGCE95%ZHIXINQUJIAN;DUIYUDANZUMUBIAOZHISHIYANSHEJI,YINGJICHUDABIAOLVJIQIDANCE97.5%ZHIXINQUJIANDEGUJI,BINGMINGQUEZHIXINQUJIANDEJISUANFANGFA。

  YINGDUISUOYOUSHIYANGUOCHENGZHONGFASHENGDEBULIANGSHIJIANJINXINGPINGJIA,BINGMIAOSHUQIZHONGLEI、FASHENGPINLVYIJIYUBEIYANZHENGQIXIEDEGUANXI。

  6.TONGJIFENXIJIEGUO

  TONGJIFENXIYINGJIYUSUOYOULINCHUANGSHIYANSHUJUFENXIDECHU,BINGYONGYUZHUANXIELINCHUANGSHIYANBAOGAO。TONGJIFENXIJIEGUOYINGZHISHAOBAOKUODANBUXIANYULINCHUANGSHIYANWANCHENGQINGKUANG、RENQUNJIXIANMIAOSHU、LIAOXIAO/XIAOGUOPINGJIAJIANQUANXINGPINGJIADENG。DUISUOYOUSHIYANDUIXIANGJINXINGANQUANXINGPINGJIAFENXI,BUNENGYILOURENHEBULIANGSHIJIAN(BAOKUOSHIYANQIANZHENGCHANG、SHIYANHOUYICHANGBINGYOULINCHUANGYIYIDESHIYANSHIZHIBIAODENG)。TUOLUOBINGLIYINGLIEBIAOZHULICHENSHUTUOLUOYUANYIN。DANZUMUBIAOZHISHEJIDESHIYAN,JIANYIYIYIXIANGXINGZHILIAOYUANZEJINXINGZHUYAOFENXI,DUIYUTUOLUOBINGLIZHUYAOLIAOXIAOZHIBIAOYINGANWUXIAOCHULI。ZHUYAOLIAOXIAOZHIBIAOQUESHISHIANZUICHAZHIFA(WOCF)JINXINGTIANBU。

  7.LINCHUANGBAOGAO

  TIJIAOGEFENZHONGXINLINCHUANGSHIYANXIAOJIE。JIANYIGENJUTONGJIFENXIJIEGUOZHUANXIEBINGCHUJULINCHUANGSHIYANBAOGAO。QIZHONGYINGTIGONGHUANZHEYIBANZILIAO(XINGBIE、NIANLING、TIZHONG、BINGZHONGDENG)。LINCHUANGBAOGAONEIRONGBAOKUO:SHIYANDUIXIANGZILIAO、SHIYANFANGFA、SHIYANHEZHUYAOZHIBIAOJIANCESHEBEI、PINGJIAFANGFAHEBIAOZHUN、SHIYANJIEGUOHEJIELUN。SHIYANJIEGUOYINGYIBIAO(HUOTU)LIECHULINCHUANGJIANCEDEZHUYAODESHUJUHETONGJIFENXIJIEGUO。SHIYANBINGLIZHONGCHUXIANDEFUFANYING、BULIANGSHIJIAN、BINGFAZHENGJIQICHULIJIEGUO。SHIYANJIEGUODESHIYONGFANWEI、JINJIZHENGHEZHUYISHIXIANG、CUNZAIWENTIJIGAIJINYIJIANDENG。

  LINCHUANGSHIYANBAOGAOYINGYUYANJIUFANGANBAOCHIYIZHI。BAOGAOSUOYOUBULIANGSHIJIANFASHENGSHIJIAN、YUANYIN、JUTIBIAOXIAN、HOUGUOJIYUSHIYANYONGQIXIEDEGUANXI,DUIYUSUOCAIQUDECHULICUOSHIXUYUYIMINGQUE。WULUNSHIYUQIHAISHIFEIYUQIBULIANGSHIJIAN,DOUYINGRUSHIJILUHEBAOGAO。DUIYINBULIANGSHIJIANERZHONGZHIYANJIUYIJICHUXIANZHONGDUHUOYANZHONGBULIANGSHIJIANDEBINGLI,JIAYITEBIEDEZHUMING。LINCHUANGBAOGAOZHONGDETONGJIFENXIJIEGUOYINGJINGTONGJIXUEZHUANJIASHENHE。

  8.JINGWAILINCHUANGSHIYANSHUJUDETIJIAOCANKAO《JIESHOUYILIAOQIXIEJINGWAILINCHUANGSHIYANSHUJUJISHUZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2018NIANDI13HAO)XIANGGUANGUIDING。

  (WU)CHANPINFENGXIANFENXIZILIAO

  YINGBAOHANFENGXIANFENXI、FENGXIANPINGJIA、FENGXIANKONGZHICUOSHIDESHISHIHEYANZHENGJIEGUO、SHENGYUFENGXIANKEJIESHOUXINGPINGDINGDENGWENJIAN。

  KECANKAOYY/T 0316《YILIAOQIXIE FENGXIANGUANLIDUIYILIAOQIXIEDEYINGYONG》ZHIDINGWENJIAN。SHENGCHANQIYEYAOCHENGLIFENGXIANGUANLIXIAOZU,ZHUYAOFUZERENDANRENZUZHANG。FENGXIANGUANLIHUODONGYAOGUANCHUANCHANPINSHEJI、SHISHENGCHAN、LIANGCHAN、SHANGSHIHOUSHIYONGJICHANPINCHULIDEZHENGGESHENGMINGZHOUQI。YAOTIXIANSHENGCHANQIYEFENGXIANGUANLIHUODONGJIHUADEWANZHENGXING,YOUQISHISHANGSHIGUANLIDEFENGXIANFENXIYUPINGJIAGUOCHENG。DUIYUSHANGSHIQIANFENGXIANGUANLIZHONGSHANGWEIRENZHIDEFENGXIAN,YINGZAISHANGSHIHOUKAIZHANXINXISHOUJI,YIDANFAXIANYICHANGJISHIJINXINGFENGXIANPINGJIA,CAIQUKONGZHICUOSHI,GENGXINFENGXIANGUANLIWENJIAN。

  SHENGYUFENGXIANFENXISHI,YAOZHUYIFENGXIANKONGZHICUOSHIXINYINRUFENGXIANNENGZHUANHUAWEIKEJIESHOUFENGXIAN,FANGNENGRENWEIFENGXIANSHOUKONG。TIXUNGUANDAOBIXUJINXINGFENGXIANYUSHOUYIFENXI,SHOUYIDAYUFENGXIANSHIFANGKEJIESHOU。TONGSHITIGONGTIXUNGUANDAOCHANPINSHANGSHIQIANFENGXIANGUANLIBAOGAO,CIBAOGAOZHIZAISHUOMINGBINGCHENGNUO:

  -风险管理计划已被正确地实施;
  -综合剩余风险是可接受的;
  -已建立产品上市后的追溯与临床应用信息收集制度。

  YINGSUIFENGXIANGUANLIBAOGAOYIBINGFUSHANGBAOKUOFENGXIANFENXI、FENGXIANPINGJIA、FENGXIANKONGZHIGAISHUGUANLIZILIAO。ZHISHAOYINGBAOKUO:

  1.产品安全特征清单;
  2.产品可预见危险(源)及危险(源)分析清单(说明危险(源)、可预见事件序列、危险情况和可能发生的伤害之间的关系);
  3.风险评价、风险控制措施以及剩余风险评价汇总表。

  DUIYUFENGXIANFENXIHEGUANLIGAISHU,YINGBAOKUOYIFENFENGXIANZONGJIE,YIJIRUHEJIANGFENGXIANKONGZHIZAIKEJIESHOUCHENGDUDENEIRONGDENG。

  (LIU)CHANPINJISHUYAOQIU

  YINGDANGANZHAO《YILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2014NIANDI9HAO)DEGUIDINGBIANZHICHANPINJISHUYAOQIU,JISHUZHIBIAOYINGDANGBUDIYUGUOJIABIAOZHUN、XINGYEBIAOZHUNYAOQIU,YINYONGBIAOZHUNYINGDANGWEIXIANXINGYOUXIAOBANBEN。DUIQIYEXUANCHENGDESUOYOUJISHUCANSHUHEGONGNENG,YINGZAICHANPINJISHUYAOQIUZHONGYUYIGUIDING。

  TIXUNGUANDAODECHANPINJISHUYAOQIUYINGCANZHAOYY 1048DENGBIAOZHUN,YIJICHANPINSHEJIYANZHENGJIEGUO、LINCHUANGYINGYONGXIANGGUANBAOGAOYUWENXIANLAIZHIDING。SHENBAOCHANPINXINGHAO、GUIGEHUAFENJINLIANGCAIYONGGUOJIABIAOZHUN、XINGYEBIAOZHUNDEBIAOSHIFANGFA,SUOYOUCHANPINDEZUJIAN、CAILIAODUIYINGGUANXIYINGMINGQUE,BUYONG“XILIE”“DENG”HANHUYONGCI。

  1.CHANPINXINGHAO/GUIGEJIQIHUAFENSHUOMING

  TIGONGCHANPINGUIGEXINGHAO、JIEGOUZUCHENGSHIYITU,LIEMINGGEZUJIANMINGCHENGJIZHIZAOCAILIAO(ZHUNQUEHUAXUEMINGCHENG、FUHEDEBIAOZHUNHUOPAIHAO)、MIEJUNFANGFA、YOUXIAOQI、BAOZHUANGCAILIAODENGYAOQIU。YINGMINGQUEGEXINGHAOGUIGECHANPINZHIJIANQUBIE,JIANYIMINGQUEZUIDASHIYONGYALIHEXUELIULIANG。TONGSHIGUIDINGTIXUNGUANDAOYUANCAILIAOBUDERENWEITIANJIAYILIERUXIANGGUANFAGUIJIWENJIANJINZHIDEHUOWEIJINGDULIXUEPINGGUDEWUZHI。

  2.XINGNENGZHIBIAO

  (1)WULITEXING

  TIXUNGUANDAOGEZUJIANWAIGUAN、CHICUN、JIETOU、WUXIELOU、KEKAOLIANJIE、WEILISHULIANG、NAIWENXINGNENG、SHIYONGSHOUMINGDENGZHIBIAO。SUOYOUZUJIANYINGJUYOUGEZIXINGNENGYAOQIU。RUBAOHANTESHUZUJIAN、JIEGOU,YINGGUIDINGGAIZUJIAN、JIEGOUDECHICUN、XINGNENGYAOQIU。RUCHANPINDAIYOUTUCENG,JIANYITIGONGTUCENGCHENGFEN、XINGNENGTEXING、WENDINGXINGHEANQUANXINGPINGJIAGUIDING。

  (2)HUAXUEXINGNENGYAOQIU

  HAIYUANWUZHI、ZHONGJINSHU、SUANJIANDU、ZHENGFACANZHA、ZIWAIXIGUANGDU、SEZE、HUAXUEWUCANLIU(RUSHIYONG)DENG。

  (3)QITAXINGNENG

  WUJUN、XIJUNNEIDUSU、REYUANHEYOUXIAOQIDENG。

  3.JIANYANFANGFA

  YOUGUANXINGYEBIAOZHUN、GUOJIABIAOZHUNGUIDINGGEGEXINGNENGJISHUZHIBIAODEJIANCEFANGFA,YINGZUOWEIGETIAOKUANDUIYINGDEJIANCEFANGFA。

  4.SHUYU(RUSHIYONG)

  三、注册单元划分原则和检测要求

  ZHUCEDANYUANHUAFENYIJU《YILIAOQIXIEZHUCEDANYUANHUAFENZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI187HAO)DENGWENJIANJINXING,BAOKUODANBUXIANYUGUANLUYUANCAILIAOBUTONG、JISHUYUANLIBUTONG、ZHUYAOXINGNENGZHIBIAOBUTONG、SHIYONGFANWEIBUTONGDENGQINGXINGSHI,JIANYIQUFENBUTONGZHUCEDANYUAN,TIGONGGEZIWANZHENGDEZHUCESHENBAOZILIAO。

  DIANXINGXINGCHANPINXUANZEBAOHANQUANBUYUANCAILIAOHEZUJIAN、JIEGOUZUIFUZA、FENGXIANZUIGAO、SHIYONGXINGNENGKEYIFUGAIBENZHUCEDANYUANQITAXINGHAODECHANPIN,JINXINGFUHEFAGUIYAOQIUDEQUANXIANGMUJIANCE。SUOYOUZUJIANJUNYINGJINXINGJIANCE,TEBIESHIJUYOUTESHUJIEGOU、XINGNENGDEZUJIAN。WANCHENGDIANXINGXINGCHANPINJIANCEHOU,TONGYIZHUCEDANYUANQITAXINGHAOKEJINXINGCHAYIXINGJIANCE。

  四、产品说明书和最小销售单元的标签样稿

  体循管道产品说明书、标签和包装标识应符合《医疗器械说明书和标签管理规定》(国家食品药品监督管理总局令第6号)、YY 1048等适用文件的要求。说明书注明适用范围,包含体循管道适用人群的说明。此外,注明推荐使用的最大和最小血流量、最大使用压力、注意事项、灭菌方式、有效期、临床操作规范等。所有信息应与临床评价文件结论和国家出台的规范性文件一致。

  五、参考文献

  1.《医疗器械监督管理条例》(中华人民共和国国务院令第680号)

  2.《医疗器械注册管理办法》(国家食品药品监督管理总局令第4号)

  3.《YILIAOQIXIESHUOMINGSHUHEBIAOQIANGUANLIGUIDING》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI6HAO)

  4.《GUANYUFABUYILIAOQIXIELINCHUANGPINGJIAJISHUZHIDAOYUANZEDETONGGAO》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2015NIANDI14HAO)

  5.《GUANYUFABUYILIAOQIXIECHANPINJISHUYAOQIUBIANXIEZHIDAOYUANZEDETONGGAO》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2014NIANDI9HAO)

  6.《GUANYUGONGBUYILIAOQIXIEZHUCESHENBAOZILIAOYAOQIUHEPIZHUNZHENGMINGWENJIANGESHIDEGONGGAO》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUGONGGAO2014NIANDI43HAO)

  7.《YILIAOQIXIETONGYONGMINGCHENGMINGMINGGUIZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJULINGDI19HAO)

  8.《ZONGJUGUANYUFABUYILIAOQIXIEFENLEIMULUDEGONGGAO》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUGONGGAO2017NIANDI104HAO)

  9. GB/T 16886.1-2016《YILIAOQIXIESHENGWUXUEPINGJIADI1BUFEN:FENGXIANGUANLIGUOCHENGZHONGDEPINGJIAYUSHIYAN》

  10. YY 1048-2016《XINFEIZHUANLIUXITONG TIWAIXUNHUANGUANDAO》

  11. YY/T 0242-2007《YIYONGSHUYE、SHUXUE、ZHUSHEQIJUYONGJUBINGXIZHUANYONGLIAO》

  12. YY/T 0114-2008《YIYONGSHUYE、SHUXUE、ZHUSHEQIJUYONGJUYIXIZHUANYONGLIAO》

  13. YY/T 0806-2010《YIYONGSHUYE、SHUXUE、ZHUSHEJIQITAYILIAOQIXIEYONGJUTANSUANZHIZHUANYONGLIAO》

  14.《DONGWUYUANXINGYILIAOQIXIECHANPINZHUCESHENBAOZILIAOZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI224HAO)

  15. ASTM F1980-16 《Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices》

  16. YY/T 0681.1-2009《WUJUNYILIAOQIXIEBAOZHUANGSHIYANFANGFADI1BUFEN:JIASULAOHUASHIYANZHINAN》

  17.YY/T 0316-2016《YILIAOQIXIE FENGXIANGUANLIDUIYILIAOQIXIEDEYINGYONG》

  18.《YILIAOQIXIELINCHUANGPINGJIAJISHUZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2015NIANDI14HAO)

  19.《YILIAOQIXIELINCHUANGSHIYANZHILIANGGUANLIGUIFAN》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJU、ZHONGHUARENMINGONGHEGUOGUOJIAWEISHENGHEJISHENGWEIYUANHUILINGDI25HAO)

  20.《JIESHOUYILIAOQIXIEJINGWAILINCHUANGSHIYANSHUJUJISHUZHIDAOYUANZE》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2018NIANDI13HAO)

  21.《YILIAOQIXIEZHUCEDANYUANHUAFENZHIDAOYUANZEDETONGGAO》(GUOJIASHIPINYAOPINJIANDUGUANLIZONGJUTONGGAO2017NIANDI187HAO)

  六、起草单位

  BENZHIDAOYUANZEYOUGUOJIAYAOPINJIANDUGUANLIJUYILIAOQIXIEJISHUSHENPINGZHONGXINBIANXIEBINGFUZEJIESHI。


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