YY/T 1842.3-2023Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is Part 3 of YY/T 1842 "Connectors for medical device liquid storage container delivery systems".

The following parts have been published.

--- Part 1: General requirements and general test methods;

--- Part 3: Gastrointestinal application;

--- Part 6: Neurological applications;

--- Part 7: Connectors for intravascular infusion;

--- Part 8: Application of citrate anticoagulants in single collection.

This document is equivalent to ISO 18250-3:2018 "Medical devices - Connectors for medical fluid containers and delivery systems - Part 3: Gastrointestinal Dao Application.

Introduction

During the development of ISO 80369-3:2016, a standard for small-aperture gastrointestinal connectors, it was discovered that the risk of incorrect connection is not limited to this risk also needs to be considered for the connections to the patient and the entire gastrointestinal system.

However, gastrointestinal fluid container connectors do not fully meet the definition of small-bore connectors, so it was decided to develop a separate standard for this type of connector to take into account the risk of incorrect connection between it and other devices such as IV bags.

To reflect current use of feed fluid reservoirs, this document includes two different designs of connectors.

YY/T 1842 "Connectors for medical device liquid storage container delivery systems" is intended to consist of the following parts.

--- Part 1: General requirements and general test methods;

--- Part 3: Gastrointestinal application;

--- Part 6: Neurological applications;

--- Part 7: Connectors for intravascular infusion;

--- Part 8: Application of citrate anticoagulants in single collection.

Medical equipment and liquid storage container transportation System connectors Part 3: Gastrointestinal applications

1 Scope

This document specifies requirements for the dimensions and design and functional characteristics of connections intended for use on gastrointestinal fluid storage containers.

This document does not specify dimensional or performance requirements for medical devices or accessories that use these connectors. These requirements are specified in the specific medical device or given in the standard of the appendix.

NOTE 1 Even if specific medical device standards do not currently require it, manufacturers are encouraged to incorporate connectors specified in this document into medical devices for the gastrointestinal tract.

It is expected that the requirements for liquid container connections specified in ISO 18250 will be included when the dedicated medical device standard is revised.

This document does not apply to threaded caps, crown caps, and screw caps, as they are not intended for medical device connections.

Devices often need to be connected to them, but they are more suitable for the field of food and beverage packaging.

Note 2.Examples of threaded caps and screw threads are given in DIN 55525:1988, ASTM D 2911-94 (2001 review), DIN 6063-1:2004, DIN 6063-2:2004, Defined in DIN168-1:1998; examples of crown caps are defined in DIN6094-1:1998, ISO 12821:2003, EN14635:2010.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

YY/T 0916.20-2019 Small-bore connectors for medical liquids and gases Part 20: General test methods (ISO 80369-20:2015,IDT) ISO 18250-1 Medical devices - Connectors for use in medical fluid containers and delivery systems - Part 1: General requirements and general test methods Note. YY/T 1842.1-2022 Medical devices Medical liquid storage container delivery system connector Part 1: General requirements and general test methods (ISO 18250-1:2018, IDT) plastics ASTM D790-10 Standard test method for flexural properties of unreinforced and reinforced plastics and electrical insulating materials tingmaterials

3 Terms and definitions

For the purposes of this document, the terms and definitions defined in ISO 18250-1 and the following apply.