The ISO 20695 standard, developed by the International Standards Organization (ISO), describes the design features and test methods of enteral feeding systems. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 20695 Enteral feeding systems - Design and testing. This standard replaced the repealed TS 1618 standard.
The said standard describes the requirements for enteral feeding systems including enteral delivery sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories. On the other hand, oral syringes are not covered by this standard.
Enteral nutrition refers to the administration of food to the digestive system either orally or through a tube. Enteral nutrition products are administered orally, via medical tubes, or via needle catheter insertion. Enteral nutrition systems are medical devices designed to facilitate the feeding of patients. The requirements and test methods described in the ISO 20695 standard are designed so that these medical devices, when used in current clinical practice, do not compromise the clinical condition or the safety of patients. Enteral fluids or substances administered incorrectly are included in the standard. An international effort is underway to reduce these incidents, and a number of international standards have been developed to provide application-specific connectors.
For example, the ISO 80369-3 standard specifies the connectors used between enteral delivery set, enteral extension sets, enteral syringes, enteral catheters, and enteral accessories. The ISO 18250-3 standard specifies fasteners intended for use between an enteral delivery set, an enteral accessory, and an enteral reservoir.
Many standards with normative reference have been considered in the application of this standard. A few of them are: ISO 7000, ISO 7886-1, ISO 7886-2, ISO 10993-1, ISO 11135, ISO 11137-1, ISO 11607-1 and ISO 11607-2.
Our organization also provides design features and testing services of ISO 20695 enteral feeding systems to enterprises within the scope of laboratory services.
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