ISO 16142-1, “Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards,” has just been released. This new standard (and it’s future Part 2 for IVD Devices) cancels and replaces the ISO/TR 16142 2nd Edition from 2006. It is intended as a guide for both standards users and developers.
One of the reasons that this revision was initiated is that the essential principles (developed by the Global Harmonization Task Force, GHTF) were updated in 2012. So the new ISO 16142-1 relies on these new principles, including a more thorough mapping of published reference standards to the GHTF criteria.
The previous document, ISO/TR 16142, was a “technical report,” having less legal weight than the status of the new ISO 16142-1, which is an International Standard. It is expected that this change will make the document more useful to authorizities with medical device safety jurisdiction. In the same vein, there is also an informative Annex D which maps the reference to essential principles by International Standards. This should be used by writers of healthcare standards as a template when similar mapping is generated.
Another feature of this publication is the comprehensive description of standards usage as a tool in demonstrating that a medical device is clinically effective and can perform in a safe manner. This is one reason that standards are so frequently used as a tool by both medical device designers and manufacturers as well as by regulators. Clarification of this situation is a timely aspect of the document.
OK, so you’re a medical device manufacturer, a conformity assessment body, a standards developer or a regulator, and you need a copy of this new standard. Remember, you’ll always want to use an authorized standards distributor like Document Center Inc. when you procure your documents. You can search for and order standards from all corners of the world at our webstore, www.document-center.com. Here is a direct link to the order page for the new ISO 16142-1.
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