Resumen
This part of ϲʿ 11608 specifies the functional and design considerations for containers to be used with
needle-based injection systems (NIS) that fulfil the specifications of ϲʿ 11608-1. It is applicable to single and
multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser
integrated in the NIS or assembled with the NIS at the time of use.
This part of ϲʿ 11608 includes specifications and test methods to describe and evaluate cartridges for use
in NIS with pen needles (as defined in ϲʿ 11608-2) and outlines design considerations for other potential
containers, including syringes to be used with a NIS.
This part of ϲʿ 11608 is not applicable to cartridges intended for dental use.
Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this
part of ϲʿ 11608.
NOTE See ϲʿ 7864 (needles), ϲʿ 8537 (insulin syringes) and ϲʿ 7886-1 (manual syringes).
Ciclo de vida
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Anteriormente
Retiradaϲʿ 11608-3:2000
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Ahora
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Revisada por
Publicadoϲʿ 11608-3:2022
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