Logo <p>Agjencia Kosovare p&euml;r Standardizim Adres&euml;: Rr. &quot;Ismail Hajdaraj&quot; p.n.10000 Prishtin&euml;/Republika e Kosov&euml;s. Tel.+ 383 38 512 779 Fax: +383 38 512 798 Email:aksinfo@rks-gov.net</p> Date: 2024-11-22
Time: 13:03


SK SSH EN ISO 9626:2020
Status: Published
Gjuha: English
Faqe: 37
Publikuar: 2020-08-25
Regjistri Kombëtar: 318/2020
Botim:
Standardet ndërkombëtare që kanë lidhje
This standard is identical to:
EN ISO 9626:2016
CEN/TC 205
This standard is identical to:
ISO 9626:2016
ISO/TC 84
Çmim: 32 €



Titulli Shqip

Tubi prej çeliku që nuk ndryshket për gjilpërën (agen) për prodhimin e pajisjeve mjekësore (ISO 9626:1991/AM 1:2001)

Titulli Anglisht

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

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.

Komitetet Teknike

KT-7 - KT. për Shëndetësi

ICS

11.040.25 - Shiringa, gjilpëra dhe kateterë
11.040.20 - Pajisje për transfuzion, infuzion dhe injeksion

Direktivë

Asnjë informacion i shtuar.

Veprim Kombëtar

SK SSH EN ISO 9626:2020 replaces SK EN ISO 9626:1995/A1:2015 - 2020-01-21
Copyright 2019 Agjencia Kosovare për Standardizim