Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)
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.
EN ISO 9187-1:2010 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010) is a CEN-endorsed international standard that specifies the materials, dimensions, capacities, performance and packaging requirements for glass ampoules used as primary containers for injectable pharmaceutical products. The standard covers three ampoule forms in current pharmaceutical use (forms B, C and D) and applies to ampoules with or without a colour break‑ring. Ampoules complying with this standard are intended for single use only.
Стандарты, упомянутые в описании
This standard is essential for anyone specifying, producing or qualifying glass ampoules for injectables, helping ensure dimensional consistency, material suitability and safe single‑use performance.