Hello. Sign In
Standards Store

ISO DIS 80369-1

2015 Edition, July 23, 2015

Complete Document

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS



View Abstract
Product Details
Document History

Detail Summary

Superseded By: ISO FDIS 80369-1

Additional Comments:
NOW A FINAL DRAFT * SEE ISO FDIS 80369-1
Format
Details
Price (USD)
Print
In Stock
Call for Quote
Add to Cart

People Also Bought These:

ISO 80369-7
ISO 80369-20
IEC 62133
ISO 14155

Product Details:


Description / Abstract:

This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT.

This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used.

These healthcare fields of use include, but are not limited to, APPLICATIONS for:

- BREATHING SYSTEMS and driving gases,

- enteral,

- urethral and urinary,

- limb cuff inflation,

- neuraxial devices, and

- intravascular or hypodermic.

This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards.

This standard does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.

NOTE 1 Subclause 5.8 allows for additional designs of SMALL-BORE CONNECTORS for inclusion in this series of standards for APPLICATIONS other than those already specified.

NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.

NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of this series of standards.
The 9000 Store