UNI CEI EN ISO 80369-1 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS
22-07-2022
01-01-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for SMALL-BORE CONNECTORS
5 Requirements for SMALL-BORE CONNECTORS for specific
APPLICATIONS
6 Additional SMALL-BORE CONNECTOR APPLICATIONS
7 PROCEDURE to assess a proposed new design of SMALL-BORE
CONNECTOR for inclusion in this series of standards
Annex A (informative) - Rationale
Annex B (normative) - Mechanical tests for verifying
NON-INTERCONNECTABLE characteristics
Annex C (informative) - APPLICATIONS of SMALL-BORE
CONNECTORS
Annex D (informative) - Reference to the Essential Principles
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC
Bibliography
Terminology - Alphabetized index of defined terms
Describes general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. Also ascertains the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used.
| DevelopmentNote |
Supersedes UNI CEI EN 15546-1. (05/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 80369-1:2010 | Identical |
| ISO 80369-1:2010 | Identical |
| CEI UNI EN ISO 80369-1 : 2011 | Identical |
| 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 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 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| 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/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 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 |
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