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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