MSZ EN IEC 80601-2-78:2020

Gyógyászati villamos készülékek. 2-78. rész: Rehabilitációs, állapotfelmérő, funkcionalitást pótló vagy tüneteket enyhítő célú orvosi robotok alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-78:2019)

Medical electrical equipment. Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (IEC 80601-2-78:2019)


Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 80601 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. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE See also 4.2 of the general standard. This particular standard 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). 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for 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. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1- 8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013, and IEC 60601-1-11:2015 apply as modified in Clauses 202, 206, 208, 210 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: Túl hosszú scope

Általános információk

Érvényes
angol
: 2020-11-01

11.040.01 - Orvosi berendezések általában

MSZT/MB 843  Gyógyászati villamos készülékek

: idt IEC 80601-2-78:2019; idt EN IEC 80601-2-78:2020


Vásárlás

: 17 680,0 Ft
(papír , PDF-fájl-letöltés)



Szabvány életútja

Előzmények

Jelenleg nincsenek előzmények

Megtekintett szabvány
MSZ EN IEC 80601-2-78:2020

2020-11-01

Utódok

Jelenleg nincsenek utódok