ISO 9626:2016 – Stainless Steel Needle Tubing for Medical Devices
In our last post, we discussed the changes made to ISO 7864:2016, the standard for sterile hypodermic needles for single use. However, ISO 7864 was…
Changes to ISO 7864:2016 – Sterile Hypodermic Needles for Single Use
ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is the latest version of the standard that specifies guidelines for…
IEC 60601-2-25, Safety and Performance of Electrocardiographs
IEC 60601-2-25 ED. 2.0 B:2011 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs addresses a…
Outline of Changes to ISO 13485:2016 Compared with the Previous Edition ISO 13485:2003
ISO 13485:2016 incorporates significant changes to quality management systems requirements for medical devices. The most significant changes pertain to added requirements: • document management• management review•…
ISO 9000 and Medical Devices
2015 marks not only an update of ISO 9001 for Quality Management Systems, but also a revision of ISO 9000: Quality Management Systems – Fundamentals…
Sterilization of Medical Devices
Sterilization of medical devices, pharmaceuticals and other medical products is critical to patient safety. Methods of sterilization involve steam, bleach, ethylene oxide, radiation among others….
Rice University Engineering Students Collaborate on Design of Cervical Collar
Rice University biomedical engineering and mechanical engineering students designed and prototyped the HeadCase cervical collar. They studied existing cervical collars and their results showed that existing cervical collars can push the head…