YY/T 1287.2-2016 颅脑外引流系统 第2部分：腰椎穿刺脑脊液外引流收集装置

ICS11.040.40

C30

中华人民共和国医药行业标准

YY/T1287.2-2016

颅脑外引流系统第2部分:腰椎穿刺

脑脊液外引流收集装置

Intracranialexternaldrainagesystem-

Part2:Collectingsetsforexternaldrainagebylumbarpuncture

2016-01-26发布2017-01-01实施

国家食晶药品监督管理总局发布

YY/T1287.2-2016

目次

前言................…..................….......…….....................…..................……·…...............皿

引言.................….................................................................................…................N

l范围……........………...........................…...............…….........…….........…·…….........1

2规范性引用文件….......….......…........................……...............…………...............…….1

3术语和定义….................……..................….........…..........…........……….1

4结构与命名…........….............................................…...................….................…….2

4.1结构…………………2

4.2命名.............…...........................................…...............…..................…..........2

5材料………………………2

6物理要求.................................................….........................……·….................…….2

6.1患者接口..............................................................…...........................…..........2

6.2引流管路……………........…...........................…......…….2

6.2.1透明度…………………………2

6.2.2微粒污染………………………2

6.2.3连接强度……........…..............................................................................….2

6.2.4密封性...........………......….........….........…….........…………….........…......….2

6.2.5抗扭结…….......................…...............……........................…·…3

6.2.6流量降低率….......…............................................................................…·…3

6.3多路开关........….........................................…................…...................….........3

6.4加药口/采样口…….....……………….........……………….........………·……3

6.4.1J总贝。……………3

6.4.2穿刺式连接件..................................................….................................…….3

6.4.3无针连接件…………………........…...............……….........………….3

6.5滴瓶(若有)..............……........................................................................……….3

6.5.1外观……………3

6.5.2滴管........…........….........................…….....................…........….......…·……3

6.5.3容量和刻度........……………….........………...............……………·…3

6.5.4压力指示标记..............………...............…......….........……………….........…….3

6.6颅内压刻度尺(若有)….........................…...........................................................4

6.6.1刻度尺单位.................….................................…….......................…........…4

6.6.2刻度和分度................................................................................……..........4

6.6.3零基准线…...........……………......….........…...............…………….4

6.6.4调节可靠性…........….........…..................................................................….4

6.7收集容器..................................................................................................…….4

6.7.1额定容量………........……….........………......……........................….........…….4

6.7.2跌落泄漏………………………4

6.7.3悬挂可靠性......................................….................….......….........................4

I

YY/T1287.2一2016

6.7.4排液口...........…........……........................….......……….........................……4

6.8排气口过滤器......•...•...……...............................................................................4

6.8.1过滤器完整性…..................................................……..................................4

6.8.2过滤器阻菌性…..............…...............……………......……..........................…..5

6.8.3过滤器疏水性或防水性.................................................................................5

6.9保护套........…....•................….........…..........................…................................5

7化学要求……........….................................…….......................................................5

8生物学要求......................................…........…....................................................….5

8.1生物相容性.................................................................................................…..5

8.2元菌…........................…..................................…........................................…..5

8.3细菌内毒素…..................................................…..........................................….5

9型式检验……........……...............……….........……….........….........