Small bore connectors for liquids and gases in healthcare applications - General requirements
Small bore connectors for liquids and gases in healthcare applications - General requirements
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BS EN 15546-1 is the first part of the series of European standards that specifies the 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 to be used to minimise the risk of misconnections of small bore connectors between different medical applications. The universal nature of the connectors used, and the proximity of several different connectors around a single patient make accidental misconnections inevitable. The consequences of such misconnections are variable but a significant number are actually or potentially fatal*. BS EN 15546-1 provides a framework to assess non-interchangeability of small bore connectors based on their inherent design and dimensions. Contents of BS EN 15546-1 includes:
Scope Normative references Terms and definitions Materials used for small bore connectors Small bore connector requirements for specific medical applications Procedure to assess proposed new small bore connector for inclusion in this series of Standards Procedure to be carried out by proposer of new small bore connector to assess the noninterchangeability with existing small bore connectors Design review Rationale for this Standard Overview of small bore connector allocation Small bore connectors for vascular systems applications Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices Bibliography
Advances in modern medicine have led to a significant rise in the number of medical devices attached to patients. Many of these devices fall into the categories of monitoring devices, diagnostic devices and drug delivery devices. Introducing a series of non-interchangeable, ...
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