DIN EN ISO 8537:2016-11

This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. It permits broader variation in design so as to not limit innovation in technology or methods of packaging. Its appearance and layout are consistent with other TC 84 International Standards, which are designed to be more performance-based than design prescriptive. Manufacturers are expected to follow a risk-based approach and employ usability engineering during the design, development and manufacture of insulin syringes. This edition introduces general requirements as design guidelines for manufacturers. This edition retains a number of limits on requirements, which were originally based on consensus opinion but subsequently have been confirmed in practice. This International Standard does not specify materials to be used for the construction and lubrication of sterile insulin syringes and needles for single use because their selection will depend, to some extent, upon the manufacturer’s specific syringe design, process of manufacture, and sterilization method. This International Standard emphasizes the importance of having individual syringes that are appropriately graduated and labelled for only one concentration of insulin in countries where more than one insulin concentration is used. Serious problems can result if a syringe is used with a concentration of insulin that is different from the one for which it was designed. Considering the need and use of higher insulin concentrations, new color codes for higher insulin concentrations are introduced in this standard. The sampling plans for inspection selected for this International Standard are intended to verify the design at a high confidence level. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example, the ISO 9000 series and ISO 13485. In some countries national regulations are legally binding and their requirements may take precedence over those in this International Standard. This standard has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and catheters" (secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN. At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") of the at DIN Standards Committee Medicine (NAMed).