ISO 11608-1, ISO 11608-2, ISO 11608-3 Testing of pen injectors / insulin pens
The standards ISO 11608-1, ISO 11608-2 and ISO 11608-3 describe the requirements and test methods for tests on pen injectors and insulin pens. These tests are particularly performed for quality assurance purposes. They are used to measure actuation force, dosage accuracy, plunger movement, among others.
Overview ISO 11608 USP 1382/382 Test requirements Dosing accuracy Pen Power Pack Connected medical devices Automation Videos Testing systems Testing software Medical brochure
Overview ISO 11608
ISO 11608: “Needle-based injection systems for medical use - requirements and test methods”
- ISO 11608-1: Needle-based injection systems
- ISO 11608-2: Needles
- ISO 11608-3:Finished containers (referenced in USP <1382> and USP <382>
- ISO 11608-4: Needle-based injection systems containing electronics
- ISO 11608-5: Autoinjectors
- ISO 11608-6: On body delivery systems
ISO 11608-1, ISO 11608-2, ISO 11608-3 with ZwickRoell
- The most important requirements when testing medical products are the reproducibility of results and the minimization of operator influences. To meet these requirements, ZwickRoell has developed automated systems for testing pen injectors (for example, for insulin). Insulin therapy normally involves the subcutaneous injection of insulin by means of prefilled syringes or insulin pens. These pens are similar to writing pens and are filled with insulin cartridges. Single-use pens are disposed of after the contents of the cartridge are dispensed, whereas reusable pens can be used year after year. For quality assurance tests on insulin pens and carpules, the standardDIN EN ISO 11608-1, DIN EN ISO 11608-2 and DIN EN ISO 11608-3 applies.
- ZwickRoell testing systems and test fixtures also fulfill the requirements of USP (United States Pharmacopeia) Chapter <1382> and <382>.
Automated testing of insulin pens and pen injectors to ISO 11608
When testing insulin pens or pen injectors, a time and resource efficient test process if often important. A zwickiLine materials testing machine with integrated torsion drive, combined with an automated testing systems, ensures reliable and cost-effective test results .
The testing assistant roboTest N supports the user with simple applications. With one magazine filling, you can typically automatically test 30 insulin pens or pen injectors. The testing assistant roboTest N can be easily adapted to changing test requirements with a high level of flexibility, without requiring special programming knowledge.
The robotic testing system roboTest R allows you to run fully automated tests on different functions of the insulin pen. You can, for example, measure the dosage setting, actuation force, glide force, and specified dosage in one continuous process. You can modify and combine the test methods of both test axes to suit your testing needs.
It uses the automation software autoEdition3 to remove insulin pens from the magazine, feed them into the testing machine, and start the test. This minimizes the possibility of inaccurate test results due to operator influence. Our solution makes the test process significantly more efficient thanks to increased specimen throughput. It is also possible to manually test specimens at any time.
The testXpert testing software together with the Expanded Traceability option to FDA 21 CFR Part 11 make it possible to create documentation for the testing process that is complete and tamper proof.
Dose accuracy to DIN EN ISO 11608-1
A testing system consisting of a zwickiLine testing machine with additional torsion drive is used to test insulin pens. This testing system can measure various pen functions, such as the dosage setting, actuation force, glide force, and specified dosage in one continuous process. You can modify and combine the test methods of both test axes to suit your testing needs.
