NEN-EN 45502-1
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
inactive
| Organization: | NEN |
| Publication Date: | 1 May 2013 |
| Status: | inactive |
| Page Count: | 53 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part 1 of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This Part 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.
Document History
June 1, 2015
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
NEN-EN 45502-1 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general...
NEN-EN 45502-1
May 1, 2013
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. The tests that are specified in EN 45502 are type tests and are to be carried out...
August 1, 2010
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. The tests that are specified in EN 45502 are type tests and are to be carried out...
October 1, 1997
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
Specifies requirements that are generally applicable to active implantable medial devices. For particular types of active implantable medical devices, these essential requirements are supplemented or...
September 1, 1993
Active implantable medical implants - Part 1: General requirements for safety, marking, and information for the clinician
Specifies requirements that are generally applicable to active implantable medial devices. For particular types of active implantable medical devices, these essential requirements are supplemented or...