CEI UNI EN/ISO 80369-7 : 1ED 2017
Current
The latest, up-to-date edition.
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
19-12-2017
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for LUER CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - LUER 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 LUER CONNECTORS for
intravascular or hypodermic APPLICATIONS
Annex F (informative) - Summary of LUER CONNECTOR
design requirements for intravascular or hypodermic
APPLICATIONS
Annex G (informative) - Summary of assessment of the
design of the LUER CONNECTOR for intravascular
or hypodermic 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
European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines dimensions and requirements for the design and functional performance of SMALL BORE CONNECTORS intended to be used for CONNECTIONS in intravascular APPLICATIONS or hypodermic CONNECTIONS in hypodermic APPLICATIONS of MEDICAL DEVICES AND ACCESSORIES.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-253. (12/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| UNI CEI EN ISO 80369-7 : 2017 | Identical |
| EN ISO 80369-7:2017 | Identical |
| ISO 80369-7:2016 | 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 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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