CEI UNI EN ISO 80369-3 : 2017
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
Hardcopy , PDF
English
01-01-2017
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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
principles
Annex I (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.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 210-214. (02/2017)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| UNI CEI EN ISO 80369-3 : 2016 | Identical |
| EN ISO 80369-3:2016 | Identical |
| ISO 80369-3:2016 | Identical |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| 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 |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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