Hivatkozási szám

MSZ EN 80601-2-30:2011

Dokumentumazonosító

150886

Cím

Gyógyászati villamos készülékek. 2-30. rész: Automatikus, nem invazív vérnyomásmérők alapvető biztonsági és lényeges teljesítőképességi követelményei (IEC 80601-2-30:2009 + 2010. januári helyesbítés)

Angol cím

Medical electrical equipment. Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + corrigendum Jan. 2010)

Alkalmazási terület

Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect measurement of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION. This standard covers electrically-powered intermittent, indirect measurement of the BLOOD PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect measurement of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1. 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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1. NOTE 2 See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201. Túl hosszú

ICS

11.040.55 Diagnosztikai készülékek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2011-01-01

A visszavonás napja

2022-05-24

Forrás

idt IEC 80601-2-30:2009/C:2010; idt IEC 80601-2-30:2009; idt EN 80601-2-30:2010

Előd

MSZ EN 60601-2-30:2001

Utód

MSZ EN IEC 80601-2-30:2020

Módosítás

MSZ EN 80601-2-30:2010/A1:2015

Kiegészítő információk

SZK-közlemények

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