I.S. EN 50061:1991
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
Hardcopy , PDF
06-02-2004
English
23-06-1992
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Specifies safety and other requirements exclusively for all types of wholly implantable cardiac pacemakers. Also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging. In addition, minimum requirements are specified for the ability of pacemakers to withstand environmental stress conditions.
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