Publication details
| Publication CODE |
Title |
| NBN EN IEC 80601-2-78:2020 (2020-04) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-78: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ROBOTS FOR REHABILITATION, ASSESSMENT, COMPENSATION OR ALLEVIATION |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
4. |
Description
IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT'S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
' external limb prosthetic devices (use ISO 22523),
' electric wheelchairs (use ISO 7176 (all parts)),
' diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
' personal care ROBOTS (use ISO 13482).
|
| Class |
C
|
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 80601-2-78:2019.
For the series NBN EN 50XXX, the standards are however complete.
|
DE version
|
EN version
|
FR version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
|
|
Origin
| Committee |
CLC/TC 62
Electrical equipment in medical practice
|
Approval
| BEC Approval |
2019-08-13 |
| NBN Approval |
2020-04-29 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2019-08-13 |
| Date of availability (d.a.v.) |
2020-04-03 |
| Date of announcement (d.o.a.) |
2020-07-03 |
| Date of publication (d.o.p.) |
2020-10-03 |
| Date of withdrawal former edition (d.o.w.) |
2023-04-03 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN IEC 80601-2-78:2020
|
2020-04-03 |
| is identical to |
IEC 80601-2-78:2019
|
2019-07-09 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
EN ISO 22523:2006 |
|
| Standard |
Foreign |
IEC 60601-1-11:2015 |
|
| Standard |
Foreign |
IEC 60601-1-8:2006 |
|
| Standard |
Foreign |
ISO 14971:2007 |
|
| Standard |
Belgium |
NBN EN 60601-1-10:2008 |
|
| Standard |
Belgium |
NBN EN 60601-1-2:2015 |
|
| Standard |
Belgium |
NBN EN 60601-1-6:2010 |
|
| Standard |
Belgium |
NBN EN 62366-1:2015 |
|
|
