The standard EN ISO 20695 ‘Enteral feeding systems - Design and testing’ was developed by CEN/TC 205 ‘Non-active medical devices’ and covers requirements for enteral feeding systems and their accessories.
Developed to supersede EN 1615 ‘Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing’ and EN 1618 ‘Catheters other than intravascular catheters - Test methods for common properties’, the publication of EN ISO 20695 represents a major step towards a safer environment for enterally-fed patients and introduces several new mechanical and technical requirements to enhance product quality (for accessories and enteral catheters with retention balloons, on risk management and usability, detectability, surface finish, information supplied, biological safety, etc.).
It provides a globally safe and secure enteral feeding system and is the first standard to be published for devices incorporating the notion of safe small-bore connectors from the EN ISO 80369 series and one of the reservoir connectors from the EN ISO 18250 series of standards. The series of what is known as small-bore connectors and reservoir connectors were developed to provide physically different connectors for each clinical application to prevent inadvertent connections between different devices that could result in wrong delivery of enteral nutrition, medications and/or hydration in healthcare applications and sometimes fatality.
The new EN ISO 20695 standard reinforces the safety of enteral feeding systems and patient care by introducing internationally harmonised requirements. The standard will not only benefit patients, but will also bring intrinsic benefits to caregivers and systems manufacturers by standardizing patient care worldwide.
For more information, please contact Jennifer Ogbonna.