Injection equipment for medical use — Part 1: Ampoules for injectables
医用注射设备第1部分:注射用安瓿
发布日期:
2010-09-30
ISO 9187-1:2010规定了可注射药品用三种形式的玻璃安瓿(B型、C型和D型)的材料、尺寸、容量、性能和包装要求。
ISO 9187-1:2010适用于带或不带断色环的安瓿;提供带有彩色断环的安瓿,以及断环颜色的选择,须经制造商和用户同意。
符合ISO 9187-1:2010要求的安瓿仅供一次性使用。
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.