AAMI CN3 and AAMI CN20 have just been released. They are provisional standards, an unusual move for this standards developing organization. Each adopts a draft ISO standard in advance of final approval of the document by ISO. If accepted, they will become ANSI/AAMI/ISO publications. AAMI has taken this unprecedented step of publishing the ISO final drafts as provisional standards rather than drafts due to urgent needs here in the U.S. with regards to patient safety. Here’s some information on each:
AAMI CN3, “Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications”
This is the provisional adoption of ISO 80369-3 with the same title. When the ISO edition is published (expected in 2015), the AAMI CN3 will be replaced with the ANSI/AAMI/ISO 80369-3 and purchasers will get a no-charge pdf copy of the update.
This provisional edition adopts the ISO/DIS 80369 Draft Edition 3.2. Users of course will realize that since the adopted ISO is a draft, the proposed standard is subject to change without notice.
The new ISO series has been developed to insure that fluids that are delivered internally to patients (through the alimentary canal or intravenously) are only the appropriate medication and not other fluids or gases. How can this be achieved? By the use of different connectors for different applications, making miconnections less likely or impossible.
The Part 3 specifically deals with the administration or removal of liquid or gas from the gastrointestinal tract. This document specifies the dimensions of small-bore connectors for medical devices or accessories for this purpose. It also confirms that these types of connectors should not be the same as those of a series of other ISO standards on various temperature sensors and mating ports.
AAMI CN20, “Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods”
This provisional standard is the adoption of the proposed ISO 80369-20, of the same title. Again, assuming that the draft will be adopted and published, the purchaser of the AAMI CN20 can expect a no-charge pdf copy of the ANSI/AAMI/ISO 80369-20 when released.
As the committee has been working on this new series, they came to the realization that test methods for all the parts would be very similar. So they decided to issue a separate document to address the test methods separately. This is that standard. The 41-page publication reviews 9 separate tests with an Annex with the details for each. There’s also an Annex A which gives the user an overview of the requirements and guidance for their proper application. It gives specific information for each of the tests as defined in the remaining Annexes.
FYI: When the ISO 80369 series is fully issued, it will be comprised of the following Parts:
- Part 1: General requirements
- Part 2: Connectors for breathing systems and driving gases applications
- Part 3: Connectors for enteral applications
- Part 4: Connectors for urethral and urinary applications
- Part 5: Connectors for limb cuff inflation applications
- Part 6: Connectors for neuraxial applications
- Part 7: Connectors for intravascular or hyopdermic applications
- Part 20: Common test methods
All parts are currently in process with the exception of Part 4.
If AAMI CN3 and AAMI CN20 apply to any of your products, you’ll want to get your copy of the new provisional standards right away. You can purchase them from Document Center Inc. in paper format or for pdf download at www.document-center.com. And they can be included in our multi-user subscription access product, Standards Online. Just check in with our staff for more details. They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Remember, we’ve been working with customers like you since 1982 to ensure that you meet your compliance obligations. Make us your Standards Experts!
