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 October 1997 |
| Status: | inactive |
| Page Count: | 53 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
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 modified by the requirements of particular standard which form additional parts of this standard. The test are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.
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...
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...
NEN-EN 45502-1
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...