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RS ISO 11040-8: 2016
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

Abstract

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.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11040-8: 2016	ADOPTED ISO STANDARDS	Health care technology	17	First Edition Jul 2026	Available