I.S. EN ISO 80369-6:2016
Current
The latest, up-to-date edition.
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO/IEC/DIS 80369-6:2014)
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for neuraxial SMALL-BORE
CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for neuraxial
APPLICATIONS
Annex C (normative) - Reference CONNECTORS for testing
SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex D (informative) - Assessment of MEDICAL DEVICES
and their attributes with CONNECTIONS within this
APPLICATION
Annex E (informative) - Summary of the usability requirements
for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
design requirements for neuraxial APPLICATIONS
Annex G (informative) - Summary of assessment of the design
of the SMALL BORE CONNECTORS for neuraxial
APPLICATIONS
Annex H (normative) - Mechanical tests for verifying
NON-INTERCONNECTABLE characteristics
Annex I (informative) - Reference to the essential principles
Annex J (informative) - Terminology - alphabetized index
of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Defines requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS.
| DocumentType |
Standard
|
| Pages |
66
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 80369-6 : 2016 COR 2016 | Identical |
| ISO 80369-6:2016 | Identical |
| EN ISO 80369-6:2016 | Identical |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 3040:2016 | Geometrical product specifications (GPS) Dimensioning and tolerancing Cones |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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