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  • BSI
    BS ISO 11040-8:2016 Prefilled syringes - Requirements and test methods for finished prefilled syringes
    Edition: 2016
    $316.70
    / user per year

Description of BS ISO 11040-8:2016 2016

This part of ISO 11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together with ISO 11040-5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.

Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of this part of ISO 11040.

NOTE 1 This part of ISO 11040 can also be used as a guidance for other types, designs and/or sizes of prefilled syringes, e.g. dual chamber prefilled syringes.

NOTE 2 In case the finished prefilled syringes are used in a needle-based injection system, see also ISO 11608-3.

NOTE 3 Attention is drawn to applicable national or regional regulations such as Ph. Eur1), USP2) or JP3).

NOTE 4 Finished prefilled syringes containing so-called borderline products, e.g. hyaluronic acid, are included in the scope of this part of ISO 11040, though they are not always regulated as a pharmaceutical product.



Standard NumberBS ISO 11040-8:2016
TitlePrefilled syringes - Requirements and test methods for finished prefilled syringes
StatusRevision Underway
Publication Date2016-11-30
Identical National Standard OfISO 11040-8:2016
DescriptorsLibrary and information science, Health and safety requirements, Test methods, Syringes, Injection instruments, Drug administration
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/212
ISBN978 0 580 87310 2
PublisherBSI
Pages20

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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