There’s a new standard from ISO on sleep apnoea equipment: ISO 80601-2-70, “Medical Electrical Equipment – Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment.” This new issue is available now from Document Center Inc. You can purchase your authorized copy in paper format, for pdf download or as part of our multi-user Standards Online subscription service. This new document replaces the ISO 17510-1, which is now obsolete.
The ISO 80601-2-70 not only is an update of the ISO 17510-1 but also includes an alignment of the information with IEC 60601-1, Edition 3.0, and IEC 60601-1-11. It contains a multitude of changes. Most notably, it identifies essential performance for sleep apnoea breathing equipment and accessories. It also adds new symbols and tests to be used for therapy performance.
For those of you using the ISO 17510-1, you’ll note that the committee suggests a 3 year transition period for new design equipment and of 5 years for equipment already in production. However, you’ll want to follow the exact implementation dates as issued by any legal jurisdiction where you sell product.
Another thing to note about this standard is that is covers equipment intended to be used for what’s called obstructive sleep apnoea (OSA). It is not meant to cover therapy equipment that’s used for central sleep apnoea, where the brain actually fails to initiate a breath.
Also, equipment covered by this standard is for patient use. And ISO 17510-2 remains in force for requirements for masks and accessories used to connect the patient to the equipment itself. That is, ISO 80601-2-70 covers the equipment and breathing tube. The ISO 17510-2 covers the mask and headgear. There is a patient/connection port that connects the two elements.
This standard will not only provide you with specific information for your equipment, like tests, markings, and so on. It also gives you a number of tables with information on how ISO 80601-2-70 relates to the other equipment safety standards that you’ll be required to meet.
Also, a final point. This is an unusual series in that some of the documents in the 80601-2 group are published by IEC and some are published by ISO. Should you go to search for a document in this series, you’ll want to be aware that you may need to search by the acronyms of both source organizations.
Meantime, if your company makes sleep apnoea equipment, you’re going to need a copy of this new standard. You can order it online at Document Center’s webstore, www.document-center.com. Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been working with customers like you since 1982. Our expertise is unparalleled. Make us your Standards Experts!
