Usually when device designers think of ISO in relation to suppliers, they think of overall quality system registration (ISO 9001:2008 or ISO 13485,) biocompatibility of materials (ISO 10993) or freedom from particulate contamination (ISO 14644 Level 8, formerly known as Class 100,000.) But there are other standards that could influence product designs in the future. Value Plastics wants you to know more about ISO Standard 80369, one such standard under development that could influence future design decisions you make.
What is ISO?
ISO, the International Organization for Standardization, is based in Geneva, Switzerland. It’s an umbrella organization that is composed of standards-writing bodies in each of its 160 member countries. In the USA, the member body is ANSI, the American National Standards Institute.
If the whole idea of standards sounds intrusive, think of what life would be like if every appliance you purchased needed a unique plug and wall socket. Standards are the reason we have universality in critical areas but yet have freedom in others; for another example, think of your automobile. Directional signal arms are always on the left side of the steering wheel and horn buttons inside the wheel circumference but other controls for windshield wipers, speed controls, ignition, etc., may be in a number of places depending on the inputs provided to the designer and the manufacturers’ customer research.
For medical devices and instruments in the USA, ANSI has essentially delegated its work to AAMI, the Association for the Advancement of Medical Instrumentation, to organize technical committees and working groups that produce standards, recommended practices and technical information reports for medical devices. Value Plastics is a member of AAMI and participates in this work.
AAMI organizes USA participation in Technical Committee 210 (TC 210), which governs quality management and corresponding general aspects for medical devices, including how the device is experienced when it is used. Also included are standards for small-bore connectors (below 8.5 mm ID) which are used in many devices and influence device operation, although connectors in and of themselves are not considered to be medical devices. The brief of TC 210 is to develop consensual standards on overall device operating characteristics, not specific device performance requirements.
In 2007, TC 210 established a joint working group (JWG) to work on consensual standards for small-bore connectors. Value Plastics participates in this working group.
Why are ISO and AAMI concerned with little plastic connectors?
When you think about it, the connector, even if small and inexpensive, is an extremely important part of any device. The device may be put into operation through the connector, and connector characteristics may directly influence how easy a device is to use. The connector is often a primary way the user, whether a healthcare professional or patient, engages with the product. Good connector design becomes a critical part of proper device use.
The efforts of the TC210 joint working group are what lead us to now to ISO 80369, small-bore connectors for liquids and gases for healthcare applications.
ISO 80369 Particulars
The proposed standard is divided into 7 sections. The first section identifies the general requirements for small-bore connectors and the following six identify specific requirements for connectors falling into one of the following general application areas:
- breathing and driving gases,
- vascular access and IV administration,
- limb cuff inflation, including NIBP cuffs and tourniquets
- neuraxial access
- urinary products
- enteral feed products
ISO 80369-1, General Requirements, is in a fairly early stage of development. The worldwide bodies have voted on whether or not to adopt the standard and commented on the standard, and the working group is evaluating the comments received for inclusion in the final document. Little work has been done on requirements for the other areas mentioned (with the exception of breathing and driving gases, which have a number of standards in effect now.) As more information becomes available we will feature that in a future FLOWPATH article.
How can I find out more?
Contact Value Plastics. Value Plastics participates in the worldwide Joint Working Group for ISO 80369 and would be happy to fill you in on the Group’s work and how you can influence it.