YY/T 0916.1-2014 Replaced Industry standards-Medicine

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

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0916.1-2014

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 18 pages

Scope

This part of YY/T 0916 specifies the general requirements for small-bore connectors used in the medical field to transport liquids or gases. These small-bore connectors are used in medical devices or accessories intended for use on patients.
This part also specifies the medical fields of application for these small-bore connectors.
The applications in these medical fields include (but are not limited to):
——Respiratory system and driving gas applications;
——Gastrointestinal applications;
——Urinary tract applications;
——Inflation of limb airbags;
——Axial applications;
——Intravascular and subcutaneous applications.
The small-bore connectors specified in this part are not interchangeable with the following connectors:
——Cone heads and cone sleeves specified in ISO 5356-1:2004 and YY 1040.2-2008;
——Temperature sensor connectors and mating ports specified in Appendix DD of ISO 8185:2007;
——Cone heads specified in EN 13544-2:2002.
This part provides a non-interchangeability assessment of small-bore connectors based on their own design and dimensions to reduce the risk of incorrect connection between medical devices or accessories in different applications and the risk of incorrect connection of medical devices with 6% Luer connectors. Other requirements for non-6% Luer connectors will be specified in other parts of this standard.
This part does not specify the requirements for medical devices or accessories using these small-bore connectors. These requirements will be given in the relevant standards for specific medical devices or accessories.
Note 1: It is expected that new small-bore connectors will be included in ISO 80369 after being evaluated according to the procedures given in Chapter 6.
Note 2: Although current relevant medical device standards do not require manufacturers to implement the performance requirements of small-bore connectors specified in this standard in m