ISO 20695:2020 pdf download – Enteral feeding systems – Design and testing
This document establishes design, safety and performance requirements for enteral feeding systems including enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters and enteral accessories. This document requires that enteral devices and accessories employ the specified connectors in a manner that establishes fluid flow in the female to male direction. In the past, the medical device and enteral nutrition industry supplied enteral giving sets and extension sets with a range of connectors. A male Luer tip to fit a female Luer port on enteral feeding catheter is a standard intravenous or parenteral connector combination. Since 2007, the UK National Patient Safety Agency (NPSA) has recommended that these should not be used for administering oral or enteral liquids, and it was further recommended that healthcare organizations not purchase those. Experience in the UK has demonstrated that a reversed (female to male) configuration can reduce inadvertent connection of enteral feeding lines to intravenous ports. This medical device orientation has found broad acceptance in the United Kingdom. Enteral administration and extension sets should not contain any in-line female administration ports or connect to the patient using a male terminal connector.
Concerns raised about the potential suitability of one single standard connector for specialized needs of very specific patient populations is the reason why CEN/TC 205/WG 16 decided to allow the use of connectors as defined by ISO 80369-1:2018, 6.2. Connectors in conformity with ISO 80369-1:2018, 6.2 are either proprietary or state-of-the-art de facto standard connectors, that, despite lacking a univocal definition into a published standard, satisfy the basic safety requirements.
A manual syringe is a medical device consisting of a graduated barrel and a plunger in which liquids are stored and transferred to a patient by means of manual operation of the medical device. This medical device would conform to the requirements of ISO 7886-1, in accordance with Table 1. A pump syringe is a medical device consisting of a graduated barrel and a plunger in which liquids are stored and transferred to a patient by means of operation of the medical device by a power-driven syringe pump. This medical device would conform to the requirements of ISO 7886-2, in accordance with Table 2. A gravity syringe is a medical device consisting of a graduated barrel with or without some filtering media in which liquids are stored and transferred to a patient by means of gravity. A hanging bracket may be provided. The barrel of this medical device would conform to the requirements of ISO 7886-1, in accordance with Table 1. A bulb syringe is a medical device consisting of a graduated barrel and an elastomeric bulb in which liquids are stored and transferred to a patient by means of manual operation of the medical device. The barrel of this medical device would conform to the requirements of ISO 7886-1, in accordance with Table 1. For the purposes of this document, an enteral syringe is not intended to mean a reservoir barrel such as a feeding or hydration bag, bottle or commercial food barrel.