CEN - EN ISO 8536-10
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment
| Organization: | CEN |
| Publication Date: | 1 June 2015 |
| Status: | active |
| Page Count: | 22 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
This part of ISO 8536 includes the following:
a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions.
b) units with injection site or check valve;
c) stoppers or adapters.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
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