ISO 5832-1 has just been updated. The standard is titled “Implants for surgery – Metallic materials – Part 1: Wrought stainless steel.” It is the first part of a 12-item series on the topic. The new 5th Edition cancels and replaces the previous 2007 4th Edition with it’s corrigendum from 2008 (correction sheet). The new update is a technical revision.
Why use metallic materials specified in standards for surgical implants? Of course, putting any foriegn substance into the human body will create reactions. Metallic materials clearly specified in standards like ISO 5832-1 provide you with known levels of biological response. These have been shown to be within an acceptable level when used in appropriate applications.
Have you been using ASTM standards to define metallic materials used in your medical devices? You will want to know that the ISO 5832-1 describes the same alloy (UNS S31672) that is referred to in the ASTM F138 and ASTM F139. This is wrought 18Chromium-14Nickel-2.5Molybdenum stainless steel. This type of steel was also referenced in the now obsolete DIN 17443. One thing to note is that units of measurement in the ASTM standards are feet/inches while the ISO standard’s are metric of course.
While some organizations like ASTM do provide redline editions to help you spot the changes from one revision to another, ISO usually does not. So there is no guidance from the source organization on where the changes have been made. You will need to review the two documents side-by-side to see how the update will affect your processes.
However, because this update has technical changes, you’ll need a copy in order to be using best practices within your organization. Choose an authorized distributor like Document Center Inc. in order to assure that you are meeting copyright requirements. You can search for and order standards with confidence at our webstore, www.document-center.com. Here is a direct link to the order page for ISO 5832-1 for your convenience.
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