Project No.ISO 11608-3:2012
Title<p>This part of ISO 11608 specifies the functional and design considerations for containers to be used with</p> <p>needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and</p> <p>multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser</p> <p>integrated in the NIS or assembled with the NIS at the time of use.</p> <p>This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use</p> <p>in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential</p> <p>containers, including syringes to be used with a NIS.</p> <p>This part of ISO 11608 is not applicable to cartridges intended for dental use.</p> <p>Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this</p> <p>part of ISO 11608.</p> <p>NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).</p>
Registration number (WIID)52527
Scope<p>This part of ISO 11608 specifies the functional and design considerations for containers to be used with</p> <p>needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and</p> <p>multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser</p> <p>integrated in the NIS or assembled with the NIS at the time of use.</p> <p>This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use</p> <p>in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential</p> <p>containers, including syringes to be used with a NIS.</p> <p>This part of ISO 11608 is not applicable to cartridges intended for dental use.</p> <p>Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this</p> <p>part of ISO 11608.</p> <p>NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).</p>
StatusAtcelts
ICS group11.040.25