ISO 8536-8-2015 pdf download.Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus.
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).
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 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE These terms and definitions are specifically applicable to Annex B.
3.1 filling volume
V F volume of tube during „pressure less“-filling respectively filling by gravity, the tube remains unstressed
Note 1 to entry: The filling volume is to be equated with the calculated volume of the tube.
3.2 storage volume
V S
tube volume during pressurization equal to filling volume (V F ) plus bolus volume (V S ):
3.3 bolus volume
V B
increased tube volume during pressurization (storage volume V S ) in comparison to the unstressed tube (filling volume V F )
Note 1 to entry: For illustration of the bolus volume see Figure 1.
4 General requirements
4.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 2, 3, and 4. These figures illustrate examples of the configuration of infusion sets and air- inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 3 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 3 used with separate air-inlet devices as illustrated in Figure 4, or infusion sets as illustrated in Figure 2 shall be used for rigid containers.
4.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closurepiercing device or needle.
5 Materials
The materials from which the infusion set and its components are manufactured shall comply with the requirements as specified in Clause 6. Where components of the infusion set come into contact with the infusion solution, the materials additionally shall comply with the requirements as specified in Clause 7 and Clause 8.
6 Physical requirements
6.1 Particulate contamination
ISO 8536-4 applies.
6.2 Tensile strength
When tested as specified in A.2, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
6.3 Leakage
The infusion set shall be impermeable to air, microorganisms and fluids.
Neither air nor water shall escape when tested according to A.3.2 and A.3.4, and no air shall enter when tested according to A.3.3.
6.4? Male? conical? fitting
The male conical fitting must be in accordance with ISO 594-2.
6.5 Injection site
The injection site shall enable injection into the tubing. There shall be no leakage of more than one
falling drop of water when tested according to A.4.
6.6? Fluid? filter
ISO 8536-4 applies.
6.7? Flow? rate? of? infusion? fluid
ISO 8536-4 applies.
6.8 Closure-piercing device
ISO 8536-4 applies.
6.9 Air-inlet device
ISO 8536-4 applies.
6.10 Drip chamber and drip tube
ISO 8536-4 applies.
6.11 Tubing
ISO 8536-4 applies.
6.12 Flow regulator
ISO 8536-4 applies.
6.13 Protective caps
ISO 8536-4 applies.
6.14 Storage volume
The storage volume shall be stated according to 10.2 i). For a definition of the storage volume and for a test method for the determination of the storage volume see Annex B.
7 Chemical requirements
ISO 8536-4 applies.
8 Biological requirements
ISO 8536-4 applies.ISO 8536-8 pdf download.ISO 8536-8 pdf download
