Esterline Connection Technologies – Souriau is qualified ISO 13485 for the manufacturing of its connectors for medical devices.
With the introduction of the JMX plastic Push-Pull series, Souriau has made a distinguished entry into the market for connectors for electronic medical equipment. As well as superior technical characteristics, the perfectly-adapted design corresponds to medical device manufacturers’ requirements in terms of aesthetics and functionality.
ISO 13485 is the system standard which applies to the manufacturing of all medical devices. As a component manufacturer, Souriau is not obliged to comply with this regulation. However, from marketing as well as an ethical point of view, the decision to apply ISO 13485, already in the design phase and later in the production and quality control phases, was never a question for the company.
In contrast to other industrial field domains, where connector standards are extremely strict, in the medical sector it is mainly a question of respecting complementary user risk analysis requirements. For every function and every part of the product; contacts, mating system, polarity key, cable strain relief, sterilization, waterproofing, each aspect the JMX plastic connectors has undergone in-depth study and rigorous testing throughout the design process. Souriau, which works under the most stringent norms, both in production and also in its products, was able to rapidly gain ISO 13485 qualification.
Connectors in the JMX plastic family are waterproof (IP68 or IP50), sterilizable, ergonomic, bio-compatible (no irritations or allergies caused through skin contact) and reliable in the connection/disconnection operations performed by healthcare personnel. The series consists of nine configurations ranging from 2 power contacts to 12 signal contacts. In this context, it is significant that Souriau has been manufacturing connectors with Push-Pull locking for many years, in the form of the JDX and JBX metal series for industrial applications.
Qualified in accordance with the UL 1977 and IEC 60601 standards, the target market for JMX connectors includes all types of medical devices which are in contact with patients; diagnostics and monitoring equipment, scanners, mammography, and artery monitoring. They can also be found in surgery applications, catheters, chromatography, analysis laboratories, physiotherapy, laser generators and liposuction equipment. The constant evolution of medical devices and the continuous stream of new types of equipment open up a large spectrum of opportunities for these connectors.
This connector series ensures that the equipment can be connected safely and easily. A JMX connector needs only two fingers to connect or disconnect the system. This operation can be done in complete safety by nurses, doctors or even by patients. When you push to connect, an audible click confirms the connection has been made. The corresponding socket for each plug can be identified by colored rings. To disconnect, a simple Push-Pull on the connector is all that is needed.
With the first market launch in the first quarter of 2017, JMX plastic was on display at the recent Compamed Fair in Düsseldorf. The products are now available in the Souriau sales network and specialist distributors for medical products. According to Jérémie Chang, Product Manager of the Push-Pull Series, “Compamed was the starting point where we first introduced JMX plastic. We are now in the customer design-in phase, implementing the products on new equipment from the principal German, Italian, Swiss and French manufacturers as well as in the USA, with the help of our sales force, representatives and local distributors.”
Esterline Connection Technologies, SOURIAU- SUNBANK