EN ISO 80369-6 : 2016 COR 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 80369-6:2016, CORRECTED VERSION 2016-11-15)
13-04-2016
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.
Committee |
JTC 3
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
NEN EN ISO 80369-6 : 2016 + COR 2016 | Identical |
NS EN ISO 80369-6 : 2016 | Identical |
DIN EN ISO 80369-6 E : 2016 | Identical |
I.S. EN ISO 80369-6:2016 | Identical |
OVE/ONORM EN ISO 80369-6 : 2016 | Identical |
NBN EN ISO 80369-6 : 2016 | Identical |
NF EN ISO 80369-6 : 2017 | Identical |
ÖVE/ÖNORM EN ISO 80369-6: 2018 | Identical |
UNI CEI EN ISO 80369-6 : 2016 COR 1 2017 | Identical |
PN EN ISO 80369-6 : 2016 | Identical |
DIN EN ISO 80369-6:2018-10 | Identical |
CEI UNI EN ISO 80369-6 : 1ED 2016 | Identical |
ISO 80369-6:2016 | Identical |
BS EN ISO 80369-6:2016 | Identical |
SN EN ISO 80369-6 : 2016 | Identical |
UNE-EN ISO 80369-6:2016 | Identical |
DIN EN ISO 80369-6:2016-11 | Identical |
BS EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications |
UNE-EN 80369-5:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
I.S. EN ISO 80369-7:2017 COR 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) |
UNE-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) |
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 80369-7:2017-10 | 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) |
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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