ISO 8536-9-2015 pdf free.Infusion equipment for medical use – Part 9: Fluid lines for single use with pressure infusion equipment.
This part of Iso 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by this part of Iso 8536:
a) syringe pump lines (SPL);
b) connecting lines (CL);
c) lines with integrated injection cannula (LIC).
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 594-2,1)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 7864, Sterile hypodermic needles for single use
ISO 8536-4:2010, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed ISO 8536-10, Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment
ISO 8536-11, Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment
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
3 Termes and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE These terms and definitions are specifically applicable to Annex C.
4 Materials
The materials from which the fluid lines are manufactured shall comply with the requirements as specified in Clause 5, Clause 6, and Clause Z.
5 Physical requirements
51 Transparency
Tubing of fluid lines shall be transparent. When tested as specified in Al the air-water interface shall be detectable.
5.2 Particulate contamination
The fluid lines 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.
5.3 Tensile strength
When tested as specified in A.3. all parts of a fluid line shall withstand a static tensile force of at least 15 N for 15 s.
5.4 Leakage
In the beginning of the test, the whole system shall he conditioned at the test temperature.
The fluid lines shall be impermeable to air, microorganisms, and fluids. When tested as specified in AA.
there shall be no leakage of air or water.
5.5 Adapters with female and/or male conical fittings
In the beginning of the test, the whole system shall be conditioned at the test temperature.
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 8536-9 pdf download.
Tags: Infusion equipment for medical use
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