DANSK DSF/FPREN ISO 7886-1 PDF

This part of ISO 7886 specifies requirements and test methods for verifying the design of empty sterile singleuse hypodermic syringes, made of plastic materials and intended for the aspiration and injection of fluids after filling by the end-users. This standard does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this International Standard are intended for use immediately after filling as they are not suitable for containing fluids over extended periods of time. lt excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this part of ISO 7886 are intended for use with hypodermic needles specified in ISO 7864.