BS EN 50077:1993

Cooperating organizations
National foreword
Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
4.1 Lead connector
4.1.1 Design requirements
4.1.2 Performance requirements
4.1.3 Marking
4.2 Connector cavity
4.2.1 Design requirements
4.2.2 Performance Requirements
4.2.3 Marking
Annex A (normative) Lead connector electrical separation
        test method
A.1 Specimen Preparation
A.2 Equipment
A.3 Procedure
Annex B (informative) Rationale
B.1 Need for a connector standard
B.2 Selection of the basic design concept and
       approach to the standard
B.3 Specific clauses of the standard
B.3.1 Clause 1 (Scope)
B.3.2 Clause 4 (Requirements)
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references

Specifies a connector assembly for use with leads for implantable pulse generators. See also BS 6902.

This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction.

WARNING. The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector.

This European standard supplements EN50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN50061 regarding leads.