Standard Svensk standard · SS-EN ISO 21649:2023

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2023)

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Standard Svensk standard · SS-EN ISO 21649:2023

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2023)
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Omfattning
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:
—    involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);
—    generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);
—    deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);
—    apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);
—    infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

Ämnesområden

Utrustning för transfusion, infusion och injektion (11.040.20)


Köp denna standard

Standard Svensk standard · SS-EN ISO 21649:2023

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2023)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 416 SEK
standard ikon pdf

PDF

Pris: 1 416 SEK
standard ikon

Papper

Pris: 2 265,60 SEK
standard ikon pdf + standard ikon

PDF + papper

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Produktinformation

Språk: Engelska

Framtagen av: Medicintekniska produkter för provtagning och administration av läkemedel, SIS/TK 330/AG 04

Internationell titel: Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)

Artikelnummer: STD-80041053

Utgåva: 3

Fastställd: 2023-02-13

Antal sidor: 52

Ersätter: SS-EN ISO 21649:2009