Publication details
| Publication CODE |
Title |
| NBN EN 80001-1:2011 (2011-03) |
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES
PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
2 P. |
Description
Recognizing that Medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), this international standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). This standard does not specify acceptable risk levels.
|
| Class |
C74
(EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
IEC 80001-1:2010.
For the series NBN EN 50XXX, the standards are however complete.
|
EN version
|
FR version
|
DE version
|
|
Status
Origin
| Committee |
TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2011-02-01 |
| NBN Approval |
2011-05-20 |
| Registration |
116070 |
| ICS-Code (International Standards Classification) |
35.240.80
, 11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2011-02-01 |
| Date of availability (d.a.v.) |
2011-03-18 |
| Date of announcement (d.o.a.) |
2011-05-01 |
| Date of publication (d.o.p.) |
2011-11-01 |
| Date of withdrawal former edition (d.o.w.) |
2014-02-01 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 80001-1:2011
|
2011-03-18 |
| is identical to |
IEC 80001-1:2010/ed. 1.0
|
2010-10-27 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN 60601-1 |
|
| Standard |
Belgium |
NBN EN 61907 |
|
| Standard |
Belgium |
NBN EN 62304 |
|
| Standard |
Belgium |
NBN EN ISO 14971 |
|
| Standard |
Belgium |
NBN EN ISO 16484-2 |
|
| Standard |
Belgium |
NBN EN ISO 9000 |
|
|
