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hm243 replied to the topic Verification Protocol in the forum Introduction to Design Controls 8 years, 2 months ago
Syringes are commonly used in medical care, such as for intravenous injection in hospitals. Syringes need to be tested and verified before even being used. Some of the tests used to determine the performance of the injector include ANSI, AAMI, ASTM, and ISO. One of the ISO tests includes ISO 11608 which looks at Break Loose, Glide Force, Luer Fitting, Syringe to Hub Retention and Syringe Accuracy. Other testing includes ensuring the biocompatibility of the syringe for when it is inserted into the skin. In addition, there is also transit testing and Package and Sterile Seal Integrity Testing, which deal with the packaging of the syringes. There is also Sterilization Testing, Residual FtO, LP/USP testing, and Siliconization Testing to consider. All these tests are followed for the verification process of syringes by the Eurofins Medical Device Testing.
References:
https://d1jj3zdoktl3jd.cloudfront.net/corporate-eurofins/media/12143127/10006_syringetesting.pdf