Breathing system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects (ISO 23328-2:2002)
Abstract
ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system.
It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements.
A method for assessing filtration performance of BSF is given in ISO 23328-1.
DIN EN ISO 23328-2:2009-07 (D)
Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung – Teil 2:
Aspekte, die nicht die Filtration betreffen (ISO 23328-2:2002); Deutsche Fassung EN
ISO 23328-2:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
Einleitung …………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………………..5
2 Normative Verweisungen ………………………………………………………………………………………………………5
3 Begriffe …………………………………………………………………………………………………………………………………5
4 ASF-Anschlussöffnungen ……………………………………………………………………………………………………..6
5 Prüfverfahren ………………………………………………………………………………………………………………………..6
6 Verpackung steriler ASF………………………………………………………………………………………………………..7
7 Aufschriften ………………………………………………………………………………………………………………………….7
8 Informationen des Herstellers………………………………………………………………………………………………..8
Literaturhinweise………………………………………………………………………………………………………………………………9
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42/EWG über Medizinprodukte……………..10