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Draft of Egyptian standard ES 3241-2 "Injection equipment for medical use —Part 2: one-point-cut (OPC) ampoules"


Egypt
TBT
2020-03-05
2020-05-04

This draft standard specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products.

It 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 this part of ISO 9187 are intended for single use only.

Worth mentioning is that this standard is technically identical with ISO 9187-2/2010 (confirmed in 2015)


G/TBT/N/EGY/253
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11.040.20 - Transfusion, infusion and injection equipment

Protection of human health or safety (TBT)
Transfusion, infusion and injection equipment (ICS code(s): 11.040.20)
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