60.60 Standard published May 20, 2020
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.25 Syringes, needles and catheters
Published
This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
WITHDRAWN
EN ISO 7886-3:2009
PUBLISHED
EN ISO 7886-3:2020
60.60
Standard published
May 20, 2020
