| Publication CODE |
Title |
| ISO TR 80002-2:2017 (2017-06) |
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
229.00 €
|
84. |
Description
ISO/TR 80002-2:2017(E) applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2:2017 applies to
- software used in the quality management system,
- software used in production and service provision, and
- software used for the monitoring and measurement of requirements.
It does not apply to
- software used as a component, part or accessory of a medical device, or
- software that is itself a medical device.
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
| BEC Approval |
2017-06-13 |
| ICS-Code (International Standards Classification) |
11.040.01
, 35.240.80
|
| NBN Status |
New |
|
| IEC publication date |
2017-06-13 |
| IEC stability date |
2027-12-31 |
| IEC file modification date |
2017-06-16 |
| IEC last modification date |
2019-07-10 |
|
