Standard Swedish standard · SS-ISO 11040-8:2022

Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016, IDT)

Status: Valid

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Standard Swedish standard · SS-ISO 11040-8:2022

Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016, IDT)
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Scope
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 ISO 11040-8:2016.



Subjects

Syringes, needles and catheters (11.040.25)


Buy this standard

Standard Swedish standard · SS-ISO 11040-8:2022

Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016, IDT)
Subscribe on standards - Read more Dölj
Price: 636 SEK
standard ikon pdf

PDF

Price: 636 SEK
standard ikon

Paper

Price: 1 017,60 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80035026

Edition: 1

Approved: 5/3/2022

No of pages: 20