I.S. EN ISO 80369-3:2016
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014)
Hardcopy , PDF
English
01-01-2016
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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 ENTERAL
SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - ENTERAL SMALL-BORE
CONNECTORS
Annex C (normative) - Reference CONNECTORS
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 ENTERAL applications
Annex F (informative) - Summary of SMALL-BORE
CONNECTOR criteria and requirements for
ENTERAL APPLICATIONS
Annex G (informative) - Summary of assessment of
the design of the CONNECTORS for ENTERAL
APPLICATIONS
Annex H (informative) - Reference to the essential
(informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
document and the Essential Requirements of
EU Directive 93/42/EEC
Defines the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 80369-3:2016 | Identical |
| ISO 80369-3:2016 | Identical |
| EN 1618:1997 | Catheters other than intravascular catheters - Test methods for common properties |
| 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 10241-2:2012 | Terminological entries in standards — Part 2: Adoption of standardized terminological entries |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| 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 |
| EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
| ISO 10241-1:2011 | Terminological entries in standards — Part 1: General requirements and examples of presentation |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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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