UNI CEI EN ISO 80369-1 : 2011

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS

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Superseded date: 21-07-2022

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Published date: 31-12-2010

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

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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

Abstract - (Show below) - (Hide below)

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.

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Development Note	Supersedes UNI CEI EN 15546-1. (05/2011)
Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
Superseded By	UNI CEI EN ISO 80369-1: 2019
Supersedes	UNI CEI EN 15546-1 : 2009

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN ISO 80369-1:2010	Identical
ISO 80369-1:2010	Identical
CEI UNI EN ISO 80369-1 : 2011	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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