Standard Svensk standard · SS-EN ISO 21649:2009

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2006)

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Standard Svensk standard · SS-EN ISO 21649:2009

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2006)
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Omfattning
This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system 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 also may be a permanent internal chamber designed to last through the claimed life of the device. Excluded from this International Standard 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 21649:2009

Nålfria injektorer för medicinskt bruk - Krav och provningsmetoder (ISO 21649:2006)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 140 SEK
standard ikon pdf

PDF

Pris: 1 140 SEK
standard ikon

Papper

Pris: 1 824 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

Artikelnummer: STD-71241

Utgåva: 2

Fastställd: 2009-09-28

Antal sidor: 48

Ersätter: SS-EN ISO 21649:2006