Hivatkozási szám

MSZ EN IEC 60601-2-66:2020

Dokumentumazonosító

175621

Cím

Gyógyászati villamos készülékek. 2-66. rész: Hallókészülékek és hallókészülék-rendszerek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-66:2019)

Angol cím

Medical electrical equipment. Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID 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 HEARING AIDS and to HEARING AID SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of HEARING AIDS or HEARING AID SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.9.2 and 201.9.6. NOTE See also 4.2 of the general standard. ACCESSORIES to HEARING AIDS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. HEARING AIDS do not have a MAINS PART intended for connection to AC SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING AID SYSTEM is covered by power supply, charger or other types of ACCESSORIES. ACCESSORIES with FUNCTIONAL CONNECTION to a HEARING AID may form a HEARING AID SYSTEM. HEARING AID related ACCESSORIES that are not physically connected to the HEARING AID during NORMAL USE are not considered to be APPLIED PART, because they do not directly contribute to the INTENDED USE of the HEARING AID. Wireless programming interfaces are covered by the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. Programming interfaces with wired connection to the HEARING AID are covered by the general standard. NOTE Detachable parts of HEARING AIDS, even if supplied separately (e.g. ear hooks, domes, wax guards etc.), are not considered as ACCESSORIES, but as component parts. This document does not apply to: – cochlear implants or other implanted HEARING AIDS; – bone conduction HEARING AIDS; – educational HEARING AIDS (i.e. group HEARING AIDS, auditory trainers etc.); – the application of a HEARING AID for the measurement of hearing levels; IEC 60645-1 applies; – fix installed audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1; – the sound generating function of a tinnitus masker. Túl hosszú scope

ICS

11.180.15 Siket és nagyothalló személyek segédeszközei

17.140.50 Elektroakusztika

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-09-01

Forrás

idt EN IEC 60601-2-66:2020; idt IEC 60601-2-66:2019

Előd

MSZ EN 60601-2-66:2016

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)

A szabvány

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