ISO 16061, “Instrumentation for use in association with non-active surgical implants – General requirements,” has just been updated. This standard provides users with requirements for surgical instruments used with non-active implants. These are things like scissors, cannulae, location guides, spreaders, and the like. These instruments may be linked to a power drive, however only the instruments themselves are covered in this document.
The new ISO 16061 3rd Edition from 2015 replaces the previous 2nd Edition from 2009, which is now obsolete. It is a technical update. The European adoption of the standard (EN ISO 16061) has also been updated to a 2015 Edition as well.
When you use this standard, you’ll find all the requirements for the following areas:
- Intended performance,
- Design attributes,
- Materials,
- Design evaluation,
- Manufacturing,
- Sterilization,
- Packaging, and
- Information to be supplied by the manufacturer.
These areas are in many cases defined by reference to other standards. You’ll find Annex A to be particularly helpful too. It contains a long list of typical instruments. Then it lists either the standards for materials that will be acceptable for each application or a reference to a specific tabular entry in one of three tables with the material requirements for the instrument in question.
What kinds of surgical instruments are not covered by ISO 16061? The standard is not used for instruments for dental implants, transendodontic and transradicular implants, and ophthalmic implants.
How can you get an authorized copy of the new edition? You’ll want to order from an authorized dealer like Document Center Inc. There are a number of sites proporting to sell ISO standards — Not all of them are legitimate. However, Document Center Inc. has been selling ISO standards under contract since the 1990’s. You can order all the standards you need with confidence at our webstore, www.document-center.com. For your convenience, here’s a link directly to the order page for ISO 16061. It’s available for delivery in paper format or as a pdf download.
Would you prefer to have subscription access to this ISO standard? Ask our sales staff about our Standards Online service which provides 24/7 availability to your organization. They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Remember, Document Center Inc. has been selling standards since 1982. Make us your Standards Experts!
