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EVS-EN ISO 11608-3:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)

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Kehtetu alates 17.05.2022
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ISO 11608-3:2012; EN ISO 11608-3:2012
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17.05.2022
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06.11.2012
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EVS-EN ISO 11608-3:2001
This part of ISO 11608 speciies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulil the speciications of ISO 11608-1. It is applicable to single and multi-dose containers (either illed by the manufacturer or by the end-user) which can be provided to the end-user integrated in the NIS or assembled with the NIS at the time of use.This part of ISO 11608 includes speciications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as deined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.This part of ISO 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 ISO 11608.NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).
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EVS-EN ISO 11608-1:2015

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 1: Nõelinfusiooni süsteemid
Kehtetu alates 17.05.2022
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EVS-EN ISO 11608-2:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
Kehtetu alates 17.05.2022
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EVS-EN ISO 11608-5:2012

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 5: Automatiseeritud funktsioonid
Uusim versioon Kehtiv alates 06.11.2012
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EVS-EN ISO 11608-4:2007

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
Kehtetu alates 17.05.2022