EN 50077:1993

Overview

EN 50077:1993 is a European standard published by CLC that defines a low-profile connector assembly for implantable cardiac pacemakers. The standard specifies the essential dimensions, performance requirements and appropriate test methods for connectors used to join implantable pacemaker leads to implantable pulse generators. EN 50077 aims to ensure mechanical and electrical interface consistency for components labelled as fitted with an IS-1 connector assembly part, while clarifying important limitations and safety considerations.

Keywords: EN 50077, low-profile connector, implantable cardiac pacemakers, IS-1 connector, connector assembly, pacemaker leads, pulse generators, medical device standard

Key Topics

• Scope and intended use
  • Connector assembly for linking pacemaker leads to pulse generators.
  • Applies only to components claimed to use an IS-1 connector assembly.
• Essential dimensions
  • Defines dimensional requirements required for interface compatibility (numeric specifics are in the full standard document).
• Performance requirements
  • Establishes electrical and mechanical performance criteria the connector assembly must meet under normal conditions.
• Test methods
  • Specifies appropriate test procedures to verify compliance with dimensional and performance requirements.
• Limitations and exclusions
  • Does not address all aspects of functional compatibility or system-level reliability between different leads and pulse generators.
  • Does not specify fastening methods or materials of construction.
• Safety warning
  • The connector cavity defined by EN 50077 must not be used with implantable devices capable of introducing dangerous non-pacing signals (for example, defibrillation signals) through an IS-1 connector.

Applications

Who uses EN 50077 and why:

• Medical device manufacturers - design and validate pacemaker connectors and ensure interface compatibility with leads and pulse generators.
• Component suppliers - label and certify connector parts claimed to conform to IS-1 assembly requirements.
• Test laboratories and quality assurance teams - perform the standardized tests and document compliance with the dimensional and performance criteria.
• Regulatory and procurement specialists - reference the standard when specifying or approving connector components for implantable cardiac devices.
• Clinical engineers and biomedical technicians - understand connector compatibility limits and safety warnings for device servicing and selection.

Related Standards

• EN 50061 - EN 50077 supplements this standard for components labelled with IS-1 connector assemblies; EN 50061 remains the primary reference for leads and other system aspects.
• IS-1 connector - industry term for the connector family addressed; compatibility and warning about non-pacing signals are critical when interfacing with defibrillation-capable devices.

For detailed dimensional values, test methods and compliance criteria consult the full EN 50077 document from the CLC or your national standards body.