prEN ISO 9626
Medicinos įtaisų gamybai naudojami nerūdijančiojo plieno adatų vamzdeliai. Reikalavimai ir bandymo metodai (ISO 9626:2025)
Standarto projektas Viešoji apklausaProjekto etapai
1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
Nuo 2025-11-30
iki 2026-01-29
4. Closure of enquiry
5. Submission to Formal Vote
Organizacija
CEN Europos standartizacijos komitetasICS
11.040.25 - Švirkštai, adatos ir kateteriaiTechnikos komitetas
TK 32 SveikataUžsienio technikos komitetas
CEN/TC 205Komentarų skaičius
0Komentavimo pradžia
2025-11-30Taikymo sritis
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.Ryšiai
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