BAS EN ISO 7886-3:2011
Sterilne podkožne injekcijske šprice za jednokratnu upotrebu - dio 3: šprice koje karakteriše sprečavanje ponovne upotrebe za tačno određenu dozu kod imunizacije
Opšte informacije
Status: Povučen
Broj strana: 18
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 12.05.2011
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.
ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer
ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 7886-3:2009, identičan
- ISO 7886-3:2005, identičan