YY/T 0916.1-2021Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (English PDF)

Foreword

YY/T 0916 "Small-bore connectors for liquids and gases in healthcare applications" consists of the following parts.

- Part 1: General requirements;

- Part 2: Connectors for breathing systems and driving gases applications;

- Part 3: Connectors for enteral applications;

- Part 5: Connection components for limb airbag inflation applications;

- Part 6: Connectors for neuraxial applications - Part 7: Connectors for intravascular or hypodermic applications;

- Part 20: Common test methods. This is Part 1 of YY/T 0916.

This Part was drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces YY/T 0916.1-2014 "Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements".

Compared with YY/T 0916.1-2014, the changes in the main technical content of this Part are as follows.

- Revised the normative references (see Chapter 2 of this Edition; Chapter 2 of Edition 2014);

- Revised the requirements for other small-bore connectors (see Chapter 7 of this Edition; Chapter 6 of Edition 2014);

- Revised the physical test methods in Annex B for verifying non-interconnectable characteristics to align with ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6, and ISO 80369-7 (see Annex B of this Edition; Annex B of Edition

2014);

- Added Annex D to replace the evaluation procedure for proposed new small-bore connector designs (for inclusion in ISO 80369) previously found in Chapter 7 of the earlier edition, and included a description of computer-aided design (CAD) analysis for the evaluation of non-interconnectable performance (see Annex D of this Edition; Chapter 7 of Edition 2014).

1 Scope

This Part of YY/T 0916 specifies general requirements for small-bore connectors used for conveying liquids or gases in medical applications. These small-bore connectors are intended for use in medical devices or accessories intended for patients.

This Part also specifies the medical fields of intended use for these small-bore connectors. These medical areas include (but are not limited to).

- respiratory systems and drive gases;

- gastrointestinal tract;

- urinary tract;

- limb cuff inflation;

- axonal; and - intravascular or subcutaneous.

Based on the inherent design and dimensions of small-bore connectors, this Part provides a methodology for assessing their non-interconnectable characteristics, so as to minimize the risk of misconnections between medical devices or accessories intended for different applications - whether specified in this Part or in future parts of the ISO 80369 series.

This Part does not specify requirements for medical devices or accessories using these small-bore connectors. Such requirements are provided in the relevant standards for specific medical devices or accessories.

NOTE 1: Chapter 7 allows for the design of small-bore connectors for other new applications to be included in the ISO 80369 series of standards.

NOTE 2: Although not yet required by current device-specific standards, manufacturers are encouraged to incorporate the small-bore connectors specified in this series of standards into medical devices, medical systems, or accessories. It is anticipated that future revisions of relevant device-specific standards shall consider the risks associated with transitioning to the small-bore […]