International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62D

Electromedical equipment

 

Detail

Committee
Working Groups
Project Leader

Current

Status

Frcst Pub

Date

Stability

Date

SC 62DJWG 10Mr Scott A. ColburnPPUB2019-012020

History

Stage
Document
Downloads
Decision Date
Target Date
AMW
62D/1082/RR PDF file 417 kB
2013-07-19 
1CD
62D/1083/CD PDF file 355 kB
2013-07-202013-07
A2CD
62D/1107A/CC Word file 258 kB
PDF file 1450 kB
2013-11-152013-11
2CD
62D/1176/CD PDF file 413 kB
2014-10-242014-10
ACDV
62D/1225/CC Word file 380 kB
PDF file 992 kB
2015-01-162015-02
ACDV
62D/1225A/CC Word file 401 kB
PDF file 1139 kB
2015-01-162015-02
CCDV
62D/1269/CDV PDF file 327 kB
2015-07-242015-05
AFDIS
62D/1302/RVC Word file 4585 kB
PDF file 1899 kB
2015-11-272016-01
CFDIS
62D/1537/FDIS
2017-10-272016-02
PRVD
2017-12-082017-12
APUB
62D/1550/RVD PDF file 616 kB
2017-12-222017-12
AFDIS
62D/1550A/RVD PDF file 1055 kB
2018-01-032018-01
CFDIS
62D/1618/FDIS
2018-08-172018-02
PRVD
2018-09-282018-09
APUB
62D/1632/RVD PDF file 535 kB
2018-10-052018-10
BPUB
2018-11-052018-10
PPUB
2018-11-062019-01
  

Abstract

ISO 80369-1:2018 This document 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 document also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include, but are not limited to:
- breathing systems and driving gases;
- enteral;
- limb cuff inflation;
- neuraxial;
- intravascular or hypodermic.
This document 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 as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document 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 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

Project

ISO 80369-1:2018 ED2

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

 

 

Associated Documents:

62D/1108/INF

PDF file 1282 kB
62D/1084/INF

PDF file 683 kB