BS ISO 11040-8:2016 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.


Cross References:
ISO 11040-4:2015
ISO 11040-5
ISO 11040-6
ISO 23908
ISO 80369-1
ISO 80369-7
ISO 80369-20
ISO 7886-1:2015
IEC 62366
ISO 7864
ISO 7886-1:2015
ISO 9626
ISO 10993-1
ISO 11608-1
ISO 11608-2
ISO 11608-3
ISO 11608-4
ISO 11608-5
ISO 14971
ISO 13408-1
ISO 17665-1
ISO 80369-3
IEC 80369-5
ISO 80369-6
ANSI/AAMI HE75
ICH Q9


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