Etude de cas
Describes requirements and test methods for sterile syringes
with or without needles for single use solely for the injection
of insulin in humans. Covers syringes for use with 40 units of
insulin/ml and 100 units of insulin/ml. Intended for use soon
after filling as they are not suitable for containing insulin
over extended periods of time. Covers normative references,
definitions and nomenclature, types of syringe, freedom from
extraneous matter, limits for extractable matter, lubrication of
syringes and needles, range of sizes, graduated scale, barrel,
piston/plunger assembly, nozzle, needles, performance of
assembled syringe, packaging and marking