ISO 8536-8:2015 pdf download.Infusion equipment for medical use —Part 8: Infusion sets for single use with pressure infusion apparatus.
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;
f) 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 form of an insert);
i) the storage volume shall be labelled according B3. In case of dedicated infusion sets the name and type of pressure infusion apparatus shall be additionally given by the manufacturer;
j) the letter NP”, 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 ± 0,1) g.
lithe available space is too small to give all this information in legible characters and/or symbols, the information may be reduced to e) and 0. In this case the information as required in this subclause shall be given on the label of the next bigger shelf or multi-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;
f) 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 form of an insert);
i) the storage volume shall be labelled according B3. In case of dedicated infusion sets the name and type of pressure infusion apparatus shall be additionally given by the manufacturer;
j) the letter NP”, 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 ± 0,1) g.
lithe available space is too small to give all this information in legible characters and/or symbols, the information may be reduced to e) and 0. In this case the information as required in this subclause shall be given on the label of the next bigger shelf or multi-unit container.
