Developed by the International Organization for Standardization (ISO), the ISO 20695 standard specifies requirements for all enteral feeding device administration sets, feeding tubes, extension lines, syringes, and accessories.
Enteral feeding systems are designed to facilitate the delivery of enteral nutrition, medication, and hydration to humans, or the aspiration of gastric contents from humans. It is designed to pass enteral fluids or substances through the nose or mouth, or through a gastrostomy, jejunostomy, or esophagostomy. Enteral feeding catheters are placed terminally in the stomach, duodenum, or jejunum.
The requirements and test methods of this document are specified in a way that does not compromise the clinical status of these medical devices or the safety of patients when used in current clinical practice. Incidents related to enteral fluids or substances administered incorrectly, including intravenously and by airway
It has been reported.
ISO 20695 is a revision of the existing EN 1615/EN 1618* standards that has been converted into an international standard and includes the small hole connector requirements of ISO 80369 (Parts 1 and 3). This ISO 20695 standard is still under development within the CEN/TC205/WG16 group. This document does not apply to oral syringes.
The medical device will be tested according to the specified test methods. If an enteral syringe equivalent degree of safety is achieved, alternative test methods may be used and the results of these alternative test methods may be correlated with results obtained using the test methods specified in this document.
All devices supplied sterile will be sterilized using a validated and routinely controlled sterilization process in accordance with an International Standard for the applicable sterilization method to demonstrate that a maximum sterility assurance level (SAL) of 106 has been reached.
If not labeled for single use, the medical device may be cleaned, disinfected, or sterilized according to the manufacturer's instructions without affecting the medical device's ability to meet the requirements of this document during its claimed lifetime.
must be feasible.
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