I.S. EN 50061:1991
Withdrawn
SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
Hardcopy , PDF
English
06-23-1992
02-06-2004
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.
| DevelopmentNote |
1991 Edition is Partially Superseded by I.S. EN 45502-2-1 & I.S. EN 45502-2-2. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| EN 50061 : 88 AMD 1 95 | Identical |
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