Hivatkozási szám

MSZ EN 60601-2-5:2016

Dokumentumazonosító

162984

Cím

Gyógyászati villamos készülékek. 2-5. rész: Ultrahangos fizioterápiás készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-5:2009)

Angol cím

Medical electrical equipment. Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (IEC 60601-2-5:2009)

Alkalmazási terület

Clause 1 of the general standard0F 1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT. This standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD. This standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability. In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular standard specifying safety requirements for the additional function. 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. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. This particular standard does not apply to: – EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry); – EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotripters) (for information refer to IEC 60601-2-36); – ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ULTRASONIC PHYSIOTHERAPY EQUIPMENT (as defined in 201.3.216).

ICS

11.040.60 Terápiás berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-06-01

Forrás

idt EN 60601-2-5:2015; idt IEC 60601-2-5:2009

Előd

MSZ EN 60601-2-5:2001

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

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