ISO 8536-10-2015 pdf free.Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment.
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 594-2’), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 8536-4, Infusion equipment jor medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8536-8, Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus
ISO 8536-12, Infusion equipment for medical use —Part 12: Check valves
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
4 Physical requirements
4.1 Avoidance of air bubbles
All components o accessories shall be designed such that no air bubbles are detected in flow channels when tested as specified in A.1.
4.2 Particulate contamination
The accessories shall be manufactured under conditions that minimize particulate contamination. The fluid pathway surfaces shall be smooth and clean. When tested as specified in Al, the number of particles shall not exceed the contamination index.
4.3 Tensile strength
When tested as specified in A.3. the accessories and connections between components shall withstand a static tensile force of not less than 15 N for 15 s.
In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position.
4.4 Leakage
The accessories shall be impermeable to air, microorganisms, and fluids. There shall be no leakage of air or water. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no leakage of air or water.
4.5 Adapters with female and/or male conical fittings
Adapters shall be provided with a connector with female conical fitting and/or a connector with male conical fitting according to ISO 594-2.ISO 8536-10 pdf download.
Tags: Infusion equipment for medical use
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