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Continue shopping Proceed to checkout. About Us Info center Standardization. It was not possible to unsubscribe – please try again later or contact the Danish Standard Please make sure you 78866-2 logged in.
A number of testing standards have been developed for the testing of syringes; however, significant gaps remain regarding the performance requirements of pre-filled syringes. In Aprilthe FDA released a guidance document on the use of ISO standards in the testing of pre-filled glass syringes in response to adverse events related to connectivity problems when certain glass syringes are used with connecting devices such as needles, needleless Luer connectors, adapters, and transfer units.
ISO — Sterile hypodermic syringes for single use — Part 4: The ISO standards related to pre-filled or pre-fillable syringes are: Auto-disable syringes for fixed-dose immunization ISO DDL performs the following testing for hypodermic syringe testing: Glass barrels for injectables and ready-to-use pre-fillable syringes ISO — Pre-filled syringes — Part 6: Pre-Filled Syringes The use of pre-filled glass and cyclic olefin polymer COP syringes is becoming more and more prevalent as the preferred delivery device for drugs and vaccines.
Pre-filled syringes are a more efficient, reliable and convenient method for drug administration, helping to reduce drug waste and dosage errors while also improving safety. My account Shoping cart 0 Help. Do not show this again. Syringes for use with power-driven syringe pumps.
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DDL has assisted many customers in testing their pre-filled syringes per the recommendations set out by the FDA in their guidance document and is well prepared to help customers with their ISO testing needs. One of the most common methods to administer therapies is the use of hypodermic syringes to inject substances into the body.
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Sterile hypodermic syringes for Single use – Part /KS ISO – Full Catalogue Listing
This part of the Standard does not apply to syringes for use with insulin, single-use syringes made of glass, syringes pre-filled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist.
Du abonnerer allerede dette 788-2. Sterile hypodermic syringes for single use – Part 4: Sterile hypodermic syringes for single use – Part 2: The printed version is available at half price when you buy the electronic version.
Syringes with re-use prevention feature. Auto-disable syringes for fixed-dose immunization.
Kontakt venligst Dansk Standard. Syringes for use with power-driven syringe pumps ISO Syringes for use with power-driven syringe pumps. Syringes with re-use prevention feature ISO ISO — Sterile hypodermic syringes for single use — Part 3: Learn more about the different testing services provided at each location.
The ISO standards related to pre-filled or pre-fillable syringes are:. Certified by ISO