ISO 8536-8-2015 pdf free.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 594.21), 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 VF 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.
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 ilustrate examples of the configuration of infusion sets and airinlet 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 ilustrated 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.ISO 8536-8 pdf download.