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ISO 11040:2016
ISO 11040:2016 Prefilled syringes – Part 8: Requirements and test methods for finished prefilled syringes
CDN $115.00
Description
ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‚Äë4 or ISO 11040‚Äë6, together with ISO 11040‚Äë5, 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 ISO 11040-8:2016.
Edition
1
Published Date
2016-11-04
Status
PUBLISHED
Pages
9
Language
English
Format
Secure PDF
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Abstract
ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‚Äë4 or ISO 11040‚Äë6, together with ISO 11040‚Äë5, 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 ISO 11040-8:2016.
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