Withdrawn
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.
Directives related to this standards.
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
WITHDRAWN
SSH EN ISO 7886-3:2009
95.99
Withdrawal of Standard
Jun 29, 2021
PUBLISHED
SSH EN ISO 7886-3:2020
Shqip