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ILNAS-EN ISO 7886-3:2009 Edition 09/2009
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
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Abstract

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.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Directives

93/42/EEC : Medical devices
2007/47/EC : Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Implementation

start of the vote on the project      date of ratification (dor)    24/08/2009
end of the vote on the project      date of anouncement (doa)    31/12/2009
start of the vote on the final project    23/04/2009   date of publication (dop)    31/03/2010
end of the vote on the final project    23/07/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg 		14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
ILNAS-EN ISO 7886-3:2020
prEN ISO 7886-3

Relations to older standards
ILNAS-EN ISO 7886-3:2005

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters
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