ISO 8600-2, “Endoscopes – Medical endoscopes and endotherapy devices – Part 2: Particular requirements for rigid bronchoscopes,” has just been updated. The new 2nd Edition is available now from Document Center Inc. It cancels and replaces the 1st Edition from 2002 and is considered a “minor” revision. However, if you use this standard you will need to get the new Edition, as the 1st Edition is now obsolete.
Rigid bronchoscopy is an invasive surgical procedure usually performed in an operating room. These types of endoscopes allow for illumination for visualization of the larynx, trachea and bronchi. It is used for dilation, stent insertion, laser ablation, or the extraction of foreign bodies. Or it may be used as a sheath for the insertion of another endoscope, aspirator, or other devices, as well as a gas passageway.
Your ISO 8600-2 standard provides you with the usual scope, referenced documents and terms and definition clauses. Clause 4 covers requirements such as the dimensions and side apertures. Clause 5 is dedicated to the various tests you’ll use for this type of equipment. These tests include pressure drop, attachment security for jet-injectors, and so on. The last three clauses cover marking, the instruction manual, and packaging. The committee particularly points out the value of the Annex A, providing a rationale for the document. This allows those who did not work on the development of the standard to understand the reason each of the requirements have been included. A bibliography completes the publication.
The ISO 8600 series consists of 7 Parts, all specifically for medical endoscopes and endoscopic accessories. If you need a copy of this new release, any of the other parts of the series, or any ISO standard at all, head to the Document Center webstore at www.document-center.com and order your copy online. You’ll be able to purchase these standards in either paper format or for pdf download. And should you want to have multi-user access, ask our staff about our Standards Online subscription service. You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re your Standards Experts!