ISO 9187-1:2010
Injection equipment for medical use — Part 1: Ampoules for injectables
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.
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Scope
Normative references
Dimensions and designation
Dimensions
Designation
Material
Requirements
Hydrolytic resistance
Annealing quality
Breaking force
Test for breaking force
Principle
Tensile testing machine
Sampling
Number of samples
Conditioning of samples
Procedure
Expression of results
Test report
Delivery
Packaging
Marking
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Scope
Normative references
Dimensions and designation
Dimensions
Designation
Material
Requirements
Hydrolytic resistance
Annealing quality
Breaking force
Test for breaking force
Principle
Tensile testing machine
Sampling
Number of samples
Conditioning of samples
Procedure
Expression of results
Test report
Delivery
Packaging
Marking