DIN EN ISO 11608-3:2020 Edition
$33.15
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung – Anforderungen und Prüfverfahren – Teil 3: NIS-Behälter und integrierte Flüssigkeitspfade (Entwurf)
Published By | Publication Date | Number of Pages |
DIN | 2020-05 | 70 |
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Dieser Teil der ISO 11608 legt die Anforderungen und Prüfverfahren für die Konstruktionsverifizierung von Behälter und integrierten Flüssigkeitspfaden, zur Verwendung mit kanülenbasierten Injektionssystemen (NIS) fest, die die Spezifikationen der ISO 11608-1 (und gegebenenfalls anderer Teile der Reihe) erfüllen. Die von dem vorliegenden Norm-Enwurf erfassten Behälter umfassen (durch den Hersteller oder den Endanwender befüllte) Einzeldosis und Mehrfachdosisbehälter sowie Flüssigkeitspfade, die am Herstellungsort in die NIS integriert werden.*Inhaltsverzeichnis
Published Code | DIN |
---|---|
Published By | Deutsches Institut für Normung |
Publication Date | 2020-05 |
Pages Count | 70 |
Language | Germany |
Descriptors | Abmessung, Anforderung, Arzneimittel, Austauschbarkeit, Begriffe, Behälter, Benutzerinformation, Berechnung, Bezeichnung, Carpule, Datenblatt, Definition, Dosierung, Genauigkeit, Herstellerangabe, Injektionsgerät, Injektionsinstrument, Injektionsspritze, Injektor, Insulin, Kennzeichnung, Konstruktion, Medikamentenverabreichung, medizinische Ausstattung, medizinisches Gerät, Medizinprodukt, Medizintechnik, Pen-Injektor, Prüfung, Prüfverfahren, Vorratsbehälter, Zylinder |
File Size | 3.6 MB |
ICS Codes | 11.040.25 - Syringes, needles and catheters |
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