ISO 80369-1 entitled “Small-bore connectors for liquids and gases in healthcare functions – Half 1: Basic necessities” specifies the design, dimensions, and efficiency necessities for small-bore connectors supposed to be used in medical gadgets or equipment. It’s a necessary commonplace contemplating the intensive use of small-bore connectors (corresponding to, for instance, Luer Lock programs) throughout the medical machine sector. The 80369-1 commonplace, for the explanations talked about earlier than, is likely one of the key facet of the medical machine design course of, and particularly it performs a basic function inside design verification actions; additionally it is important to assert compliance with GSPR (common security and efficiency necessities) and, basically, with EU MDR 2017/745. 

Scope of ISO 80369-1

The usual ISO 80369-1 specifies the final necessities for small-bore connectors, which usually convey liquids or gases in healthcare functions. Specifcally, the requirements pertains to small-bore connectors used within the following sectors: 

• Respiratory programs and driving gases;
• Enteral; 
• Limb cuff inflation 
• Neuroaxial 
• Intravascular or hypodermic. 

One of many key traits of small-bore connector is the non-interconnection, launched to cut back the danger of misconnections between medical gadgets or between equipment for various functions. The usual ISO 80369 gives a framework for the demonstration of the non-interconnectable attribute of small-bore connectors. 

Supplies necessities

ISO 80369-1 requires that the surfaces of small connectors that want to remain separate from others should be constructed from supplies which can be actually stiff, with a measure referred to as “modulus of elasticity” being greater than 700 MPa. If there’s a unique rule within the ISO 80369 collection, then that rule applies as an alternative. Different surfaces that don’t have to preserve issues separate don’t should observe this stiff materials rule. 

Small-bore connectors incompatibility

In relation to the requirement of connector incompatibility, small-bore connectors in every utility class shouldn’t be in a position to join with small-bore connectors from different utility classes. To verify they observe the foundations, producers shall test if checks present that dangers have been lowered to acceptable ranges primarily based on the factors outlined inside ISO 80369-1 and every other standards set by the producer for stopping connections. 

Small-bore connectors for particular functions as per ISO 80369-1

Design of small-bore connectors shall observe particular guidelines primarily based on the ultimate supposed use of the medical machine containing the connectors. 

Connectors designed for enteral functions should observe the rules outlined in ISO 80369-3. Nonetheless, if utilizing these connectors poses a threat that’s deemed unacceptable for a specific medical machine or accent, they need to as an alternative adhere to ISO 80369-1. 

Equally, connectors designed for inflating limb cuffs should meet the necessities laid out in IEC 80369-5, until their use poses unacceptable dangers for a specific medical machine or accent. In such circumstances, compliance with ISO 80369-1 is critical.

In the identical manner connectors used for neuroaxial utility shall adjust to ISO 80369-6 whereas the connectors embedded to the gadgets used for intravascular or hypodermic functions shall adjust to ISO 80369-7. 

Given the significance we are going to focus on in particulars about ISO 80369-7. It’s nonetheless essential to say ISO 80369-7 units forth necessities for the design, dimensions, and efficiency of small-bore connectors utilized in intravascular or hypodermic functions. Its main objective is to stop misconnections between incompatible medical gadgets, which might result in severe affected person hurt.

Different Small-Bore Connectors

Different designs of small-bore connectors could also be utilized in a medical machine or accent, underneath the next situations:

a) They should be assessed for non-interconnectable traits, besides when connecting to a connector throughout the similar utility class.

b) They need to not pose unacceptable dangers for a particular medical machine or accent.

c) Analysis should adjust to the engineering evaluation outlined in Annex D3 of ISO 80369-1.

d) Materials traits should adhere to the necessities laid out in clause 4 of ISO 80369-1.

Moreover, these connectors should be labeled in accordance with the image supplied in part 5.4.3 of ISO 15223-1. Moreover, they need to embrace a particular warning within the directions to be used (IFU), stating: “As this medical machine makes use of an alternate small-bore connector design totally different from these specified within the ISO 80369 collection, there’s a risk of misconnection between this medical machine and one other medical machine utilizing a unique various small-bore connector. This might result in hazardous conditions and hurt to the affected person. Due to this fact, the person should take particular precautions to mitigate these fairly foreseeable dangers.”

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