EN 15546-1:2008

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

This part of the series of European Standards specifies 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.It is intended to be a reference document that can be used as a tool to minimise the risk of misconnections of small bore connectors between different medical applications.It provides a framework to assess non-interchangeability of small bore connectors based on their inherent design and dimensions.It does not specify requirements for the medical devices and accessories on which these connectors are provided. Such requirements are given in particular International or European Standards for specific medical devices and accessories.NOTE 1It is intended that new designs of small bore connectors should be included in this series of Standards after they have been assessed according to the procedure given in Clause 6.NOTE 2Manufacturers are encouraged to incorporate the small bore connectors specified in this series of Standards into medical devices or systems, even if they are not currently required by the particular device standards. It is expected that when the particular device standards are revised, requirements for small bore connectors as specified in the series of Standards will be included.NOTE 3Manufacturers and users are encouraged to report their experience with the small bore connectors specified in this series of Standards to the technical committee or task force in charge of the elaboration of the present series of Standards, to consider this feedback during the revision of the relevant part of this series of Standards.