【干货】无菌医械初包装材料的选择、设计与检测,很实用!

     

DAO

LEAD

WUJUNYILIAOQIXIEMIEJUNBAOZHUANGKEFENWEICHUBAOZHUANGHEFUSHUBAOZHUANGLIANGDABUFEN,WUJUNYIXIECHUBAOZHUANGDEGONGNENG、CHANGYONGCAILIAO、CHANGYONGDEBAOZHUANGXINGSHIJIBAOZHUANGJIANCEYAOQIUYOUNAXIENI?

WENZHANGLAIYUAN:YILIAOQIXIEZHILIANGYUJIANCE

广东11选5WUJUNYILIAOQIXIEMIEJUNBAOZHUANGKEFENWEICHUBAOZHUANGHEFUSHUBAOZHUANGLIANGDABUFEN,BACHUBAOZHUANGCHENGZUO“WUJUNPINGZHANGXITONG”,JIANGFUSHUBAOZHUANGCHENGWEI“BAOHUXINGBAOZHUANG”。WUJUNPINGZHANGXITONGJIUSHIZHIJIEHEYILIAOQIXIEJIECHU,BINGGOUCHENGWEISHENGWUZUGEPINGZHANGDEWUJUNBAOZHUANGXITONG,TASHIYILIAOQIXIEMIEJUNBAOZHUANGDEHEXINBUFEN。WUJUNPINGZHANGXITONGSHIZUIZHONGMIEJUNYILIAOQIXIEANQUANXINGDEJIBENBAOZHENG。

无菌医械初包装的功能

广东11选5(1)TIGONGWEISHENGWUZUGEHEWULIFANGHU;                            

广东11选5(2)BIXUSHIYONGYUMIEJUN;

广东11选5(3)BAOCHIWUJUNXINGHEWANZHENGXINGZHIDAOBEISHIYONG;

广东11选5(4)YIYUKAIQIHEWUJUNCHUANDI;

(5)BIAOSHICHANPIN,MINGQUEBIAOSHIXINXIYUJINGSHI。

常用材料

DUOKONGCAILIAOYIJIBUTOUXINGCAILIAO(BIRUSULIAOBOMODENG)。

常用的包装形式

广东11选5YINGXISUHE,RUANXISUHE、MIEJUNGUANDAI、DINGTOUDAIHECHUANGKOUDAIDENG。    

广东11选5YINGXIANGCAILIAOXUANZEHEBAOZHUANGSHEJIDEYINSU

YILIAOQIXIEDEJUTITEXING、YUQIDEMIEJUNFANGFA、YUQIDEYONGTU、YOUXIAOQIXIAN、YUNSHUHEZHUCUNTIAOJIANDENG。

须与灭菌过程相适应

广东11选5SUOWEIMIEJUNSHIYINGXING,SHIZHIBAOZHUANGCAILIAOHE/HUOXITONGNENGJINGSHOUMIEJUNGUOCHENGBINGDADAOZUIZHONGBAOZHUANGNEIMIEJUNSUOXUDETIAOJIANDETEXING。

广东11选5MUQIANXINGYELIZUICHANGYONGDEMIEJUNFANGFABAOKUO:HUANYANGYIWAN(EO)、JIAMASHEXIAN、DIANZISHU、ZHENGQIJIDIWENYANGHUAMIEJUN。

广东11选5WUJUNYIXIECHUBAOZHUANGDEXIANGGUANBIAOZHUNMINGQUEYAOQIU:“DANGYILIAOQIXIEXUANZEYONGHUANYANGYIWAN、ZHENGQIHUODIWENYANGHUADENGMIEJUNFANGSHISHI,WUJUNYILIAOBAOZHUANGCAILIAOBIXUJUYOUTOUQIBUFEN”。

广东11选5(1)SHIDEMIEJUNJINENGGOUJINRUWUJUNYILIAOQIXIECHUBAOZHUANGNEISHAMIEWEISHENGWU——QUEBAOMIEJUNDEYOUXIAOSHIXIAN。

(2)SHIMIEJUNQITINENGGOUCONGBAOZHUANGNEISANCHUJIEXI,JIANGDICANLIUNONGDU——QUEBAOYIHURENYUANJIHUANZHEDEANQUAN。

YOUQIZAIHUANYANGYIWANCANLIULIANGFANGMIAN,YINWEISHEJIDAOYILIAOQIXIEJIYIHUANRENYUANDEANQUAN,YAOJIANBUMENDUIYUYINGYONGHUANYANGYIWANMIEJUNDEYILIAOQIXIEYOUYANGEDEHUANYANGYIWANCANLIULIANGYAOQIU,BINGCHANGCHANGJINXINGZHUANXIANGJIANDUCHOUYAN。XUANZEYIKUANJUYOULIANGHAOTOUQIQIEZUJUNXINGNENGDEWUJUNBAOZHUANGCAILIAODUIQUEBAOHUANYANGYIWANMIEJUNDEYOUXIAOXINGYUANQUANXINGFEICHANGZHONGYAO。

医疗器械包装检测要求

1、无菌屏障系统(SBS):在ISO/EN标准中,将医疗器械包装称为无菌屏障系统。

2、所有类型无菌屏障系统(SBS)的基本要求:

  • KESHIMIEJUNJIJINRU

  • KEJINXINGMIEJUN

  • KEBAOHUBAONEIWUPIN

  • KESHIMIEJUNJIPAICHU(RUSHIYONG)

  • ZAIXIALIEGUOCHENGZHONG,BAOCHINEIRONGWUDEWUJUNXING

    (1)ZHUCUN

    (2)YUNSHU

广东11选5    (3)SHIYONGKAIQISHI

3、关于SBS确认的相关标准:

广东11选5ISO 11607-1,-2; EN868-1,-2,-3,-4,-5,-6; ASTM-GEZHONGSHIYANFANGFA;AAMI ST77

4、关于SBS确认的适用试验方法:物理试验、微生物试验

5、EN ISO 11607-1的2014年修正版将微生物屏障定义为:广东11选5在灭菌过程,搬运、配送、运输和贮存等试验条件下证明可以防止微生物侵入无菌屏障系统的特性。

6、医疗器械的SBS包装类型:

  • YICIXINGMIFENGBIANYUANDEWEISHENGWUPINGZHANGCAILIAO:WUJUNBAOZHUANGDAI、SHENTOUXINGCAILIAO

  • 广东11选5YICIXINGKEZHONGFUSHIYONGDEWEISHENGWUPINGZHANGCAILIAO,TONGGUOZHEDIEJISHUCHUANGJIANYUQUTONGLU:WUJUNBAOBU、WUFANGBU、MIANBU

  • 广东11选5KEZHONGFUSHIYONGDEWEISHENGWUPINGZHANGCAILIAO,TONGGUOLVQIHUOFAMENCHUANGJIANYUQUTONGLU:YINGZHIRONGQI

7、包装类型、构成材料及包装无菌性的方法

BAOZHUANGLEIXING

GOUCHENGCAILIAO

BAOZHUANGWUJUNXINGDEFANGFA

YICIXING

MIEJUNDAI

SHENTOUXINGCAILIAO

SULIAOMO

Tyvek

TUCENGZHI

WEISHENGWUPINGZHANGCAILIAO

+

MIFENGBIAN

YICIXING/KEZHONGFUSHIYONG

MIEJUNBAOBU

FEIZHIWUHUOZHIWU

WEISHENGWUPINGZHANGCAILIAO

+

YUQUTONGLU

CAIYONGTEDINGDEZHEDIESHEJI

KEZHONGFUSHIYONGRONGQI

JINSHUHUOSULIAO

WEISHENGWUPINGZHANGCAILIAO

+

YUQUTONGLU-

GAIZHOUWEIMIFENG

TONGGUOSUOKOUBAOCHIBIHE

LVQI/HUOFAMEN

8、按包装类型进行试验:广东11选5一次性包装袋、一次性/可重复使用的包装、可重复使用的容器

9、动态生物气溶胶试验方法,无菌性保持研究,后根据结果进行讨论:

  • 广东11选5YINGZHIRONGQIHUIYOUXIJUNQINRU,72%DEXINRONGQIHUIYOUXIJUNQINRU;

  • 广东11选5YINGZHIRONGQIBAOHANDUOGEBUJIAN,RUGUOFASHENGGUZHANG,KEDAOZHIXIJUNQINRU

  • AAMI ST77 SHIYANFANGFANENGGOUDAIBIAOMIEJUNBAOZHUANGXITONGDEZHENSHIXINGNENGMA?

  • 广东11选5DUIYILIAOJIGOUERYAN:SHIYONGFEIWUJUNQIXIESHIWAIKESHOUSHUBUWEIGANRANDEQIANZAILAIYUANZHIYI;CAIYONGDONGTAISHENGWUQIRONGJIAOSHIYANFANGFASHI,YINGZHIRONGQIHUIFASHENGWENTI;NANYIQUEDINGJIEGUOHELINCHUANGYIYI,YINWEIBUTONGYILIAOJIGOUDEQINGKUANGGEBUXIANGTONG。