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

ISO-11040-8 - 1ST EDITION - CURRENT


Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

Price:

$78.57        


Want this as a site license?

To find similar documents by classification:

11.040.25 (Syringes, needles and catheters)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

Document Number

ISO 11040-8:2016

Revision Level

1ST EDITION

Status

Current

Publication Date

Nov. 15, 2016

Committee Number

ISO/TC 76