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UNI CEI EN 15546-1 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

03-03-2011

Published date

01-01-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for small bore connectors
5 Small bore connector requirements for specific
  medical applications
6 Procedure to assess proposed new small bore
  connector for inclusion in this series of Standards
  6.1 General
  6.2 Procedure to be carried out by proposer of new
      small bore connector to assess the noninterchangeability
      with existing small bore connectors
  6.3 Design review
Annex A (informative) - Rationale for this Standard
Annex B (informative) - Overview of small bore connector
                        allocation
Annex C (informative) - Small bore connectors for vascular
                        systems applications
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC Medical devices
Bibliography

Describes general requirements for small bore connectors used in specific medical applications to convey liquids or gases to or from a patient or via intermediate systems.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy

Standards Relationship
EN 15546-1 : 2008 Identical
EN 15546-1:2008 Identical

ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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