DIN EN ISO 80369-6:2018
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016

Standard No.

DIN EN ISO 80369-6:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 80369-6:2018-10

Latest

DIN EN ISO 80369-6:2023-09

Replace

DIN EN ISO 80369-6:2016

Scope

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used in NEURAXIAL APPLICATIONS. This part of ISO 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. NOTE MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for SMALL BORE CONNECTORS, as specified in this part of ISO 80369, will be included. Furthermore it is recognised that standards will need to be developed for all MEDICAL DEVICES used for NEURAXIAL APPLICATIONS.

DIN EN ISO 80369-6:2018 Referenced Document

• ASTM D638-10 Standard Test Method for Tensile Properties of Plastics*， 2024-04-20 Update
• ASTM D790-10 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-20 Update
• DIN EN 20594-1:1995 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986); German version EN 20594-1:1993
• DIN EN 60601-1-11:2016 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 6060
• DIN EN 60601-1:2013 Medical electrical equipment.Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); German version EN 60601-1:2006 + Cor. :2010 + A1:2013
• DIN EN 62366-1:2017 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 3040:2016 Geometrical product specifications (GPS) - Dimensioning and tolerancing - Cones (ISO 3040:2016); German version EN ISO 3040:2016
• DIN EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015); German version EN ISO 5356-1:2015
• DIN EN ISO 5356-2:2013 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012); German version EN ISO 5356-2:2012
• DIN EN ISO 7886-1:2018 Sterile disposable syringes for medical use – Part 1: Syringes for manual use (ISO 7886-1:2017); German version EN ISO 7886-1:2018
• DIN EN ISO 80369-1:2011 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010); German version EN ISO 80369-1:2010
• DIN EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
• DIN EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
• DIN EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
• DIN EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007); English version of DIN EN ISO 8185:2009-07
• EN 13544-2:2002 Respiratory therapy equipment - Part 2: Tubing and connectors (Incorporates Amendment A1: 2009)*， 2024-04-20 Update
• IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO ISO IEC 27001-2013 cor2-2015 technical errata*， 2024-04-20 Update

DIN EN ISO 80369-6:2018 history

• 2023 DIN EN ISO 80369-6:2023-09 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/DIS 80369-6:2023); German and English version prEN ISO 80369-6:2023 / Note: Date of issue 2023-08-04*Intended as replacement for DI...
• 2023 DIN EN ISO 80369-6:2023 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/DIS 80369-6:2023); German and English version prEN ISO 80369-6:2023
• 2018 DIN EN ISO 80369-6:2018-10 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016
• 2018 DIN EN ISO 80369-6:2018 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016
• 2016 DIN EN ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016); German version EN ISO 80369-6:2016
• 0000 DIN EN ISO/IEC 80369-6:2014