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prEN ISO 8537 Viešoji apklausa

Komentavimo iki data 2026-02-10

Vienkartiniai sterilūs insulino švirkštai su adatomis arba be jų (ISO/DIS 8537:2025)

ISO 8537:2016 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. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

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prEN ISO 7886-1 Viešoji apklausa

Komentavimo iki data 2026-02-05

Vienkartiniai sterilūs poodiniai švirkštai. 1 dalis. Rankiniai švirkštai ((ISO/DIS 7886-1:2025)

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It 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 document are intended for use with hypodermic needles specified in ISO 7864.

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prEN ISO 7864 Viešoji apklausa

Komentavimo iki data 2026-01-29

Vienkartinės sterilios poodinės adatos. Reikalavimai ir bandymo metodai (ISO 7864:2025)

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

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prEN ISO 9626 Viešoji apklausa

Komentavimo iki data 2026-01-29

Medicinos įtaisų gamybai naudojami nerūdijančiojo plieno adatų vamzdeliai. Reikalavimai ir bandymo metodai (ISO 9626:2025)

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge). It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

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