ISO 8536-4 Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
医用输液设备.第4部分：一次性使用滴夜输液器

Clause

Test Category

3

General requirements(clause 3.2)一般要求(条款3.2)

4

Designation指定

5

Materials材料

6

Physical requirements物理需求

6.1

Particulate contamination微粒污染

6.2

Leakage渗漏

6.3

Tensile strength抗拉强度

6.4

Closure-piercing device不锈钢与过滤器滴定管输液设备

6.5

Air-inlet device进气装置

6.6

Tubing油管

6.7

Fluid filter液体过滤器

6.8

Drip chamber and drip tube滴液室和滴液管

6.9

Flow regulator流量调节器

6.10

Flow rate of infusion fluid输液的流速

6.11

Injection site注射部位

6.12

Male conical fitting扩口圆锥形装配件

6.13

Protective caps保护帽

7

Chemical requirements化学要求

8

 Biological requirements生理需求

9

Labelling标签

10

Packaging包装

Sample Size: 25pieces样品尺寸:25块

Turnaround Time: 11~13working days  周转时间:11~13个工作日

note: exclude the material biological characteristic注:不含材料生物学特性