ISO 8536-8:2015 pdf download – Infusion equipment for medical use —Part 8: Infusion sets for single use with pressure infusion apparatus.
9 Packaging
ISO 8536-4 applies.
10 Labelling
10.1 General
The labelling shall include the requirements as specified in 1fl2 and j.Q.. It graphical symbols are used. then refer to ISO 15223-1.
NOTE The presence of substances of Interest can be Indicated by using symbol 2725 of ISO 7000 by replacing the -XXX- by the abbreviation of the substance The absence of substances of interest can be indicated by crossing the respective symbol.
10.2 Label on unit container
The unit container shall be labelled at least with the following information:
a) the name and address of the manufacturer;
b) a textual description of the contents;
c) indication that the infusion set is free From pyrogens. or that the infusion set Is free From bacterial endotoxins;
d) indication that the infusion set is sterile, using the graphical symbol as given in ISO 15223-1;
e) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according to ISO 15223-1;
1) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to ISO 15223-1;
g) indication that the infusion set is for single use only, or equivalent wording, or using the graphical symbol according to ISO 15223-1;
h) instructions for use, including warnings. e.g. about detached protective caps (instructions for use may also take the lorm of an insert);
I) the storage volume shall be labelled according 1U. In case of dedicated Infusion sets the name and type of pressure infusion apparatus shall be additionally given by the manufacturer;
j) the letter P, which stands for pressure, and whose type height shall stand out clearly from surrounding text;
k) a statement that 20 drops of distilled water using an usual drip chamber or 60 drops of distilled water using a drip chamber with a micro drip tube are equivalent to a volume of (1 ± 0,1) ml or a mass of (1 ±O,1)g.
If the available space is too small to give all this information in legible characters and/or symbols, the information may be reduced toe) and F). In this case the information as required In this subclausc shall be given on the label of the next bigger shelf or multi-unit container.
10.3 Label on shelf or multi-unit container
The shelf or multl•untt container shall be labelled at least with the following information:
a) the name and address of the manufacturer;
b) a textual description of the contents;
c)the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according
to lso 15223-1;
d)year and month of expiry, accompanied by appropriate wording or the graphical symbol according
to ISO 15223-1;
e)instructions for use, including warnings, e.g. about detached protective caps (instructions for use may also take the form of an insert];
f)the letter “P” which stands for pressure, and whose type height shall stand out clearly from
surrounding text;
g)storage note.11 Disposal
Information for a secure and environmentally sound disposal of single-use infusion sets should be given.EXAMPLE“Always dispose of blood contaminated products in a manner consistent with establishedbiohazard procedures.”
A.1 Test for particulate contaminationlSO 8536-4 applies.
A.2Test of tensile strength
Expose the infusion set to be tested to a static tensile force of 15 N applied along the longitudinal axis for15 s.Inspect whether the infusion set withstands the test force applied.
A.3 Tests for leakage
A.3.1 In the beginning of the test the whole system shall be conditioned at the test temperature.
A.3.2 Connect the infusion set with the air supply and close all other openings.Apply air with an internalexcess pressure of 50 kPa to the infusion set for 15 s. Inspect the infusion set for any leakage of air underwater at [40±1)C.
A.3.3 Fill the infusion set with distilled water at (40 ± 1) °C, connect it with its openings sealed to avacuum device and subject it to an internal excess pressure of-20 kPa for 15 s. Inspect whether air entersthe upstream section of the infusion set.
This test is only applicable to the upstream section of the infusion set.
A.3.4 The downstream water-filled section of the infusion set including its flow element is tested for15 min under internal excess pressure of 200 kPa. In case of dedicated sets the maximum operationpressure of the infusion pump shall be applied. Inspect for any leakage of water at (40 ± 1) °C.
NOTE For infusion sets which do not have a flow element the entire tubing up to a point just below the dripchamber is tested under identical conditions.
A.4 Test of injection site
Perform according to IS0 8536-4, but under internal excess pressure of 200 kPa.
A.5 Test for efficiency of the fluid filter
ISO 8536-4 applies.