SSH EN ISO 9187-1:2010

Pajisjet e infuzionit për përdorim mjekësor - Pjesa 1:Ampulat për injektim (ISO 9187-1:2010)

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

Scope

ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.
ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user.
Ampoules complying with ISO 9187-1:2010 are intended for single use only.