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, small bore connectors for medical devices made from rigid or semi-rigid materials will help to reduce the incidence of misconnections and lead to a direct improvement in patient safety. Rigid or semi-rigid materials have been specified to eliminate the possibility of forcing a fit between incompatible connectors made from flexible materials. Any such series must also include the 6 % Luer which should be reserved for connections in vascular applications or with a hypodermic syringe intended for specific other medical applications such as subcutaneous, intra-muscular and intraperitoneal injections and infiltrations.
Manufacturers 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.
*The Medical Device Directive 93/42/EEC addresses this type of problem in Essential Requirement 1.2. (solutions adopted for the design and construction of devices must conform to safety principles, taking into account the generally acknowledged state of the art. In seeking the most appropriate solutions, the manufacturer must apply the following principles in the following order: eliminate or reduce risk as far as possible (inherently safe design and construction, etc.) and 9.1 (if the device is intended for use in combination with other devices or equipment, the whole combination, including the connector system must be safe, etc.)
