Hivatkozási szám

MSZ EN IEC 80601-2-30:2020

Dokumentumazonosító

173736

Cím

Gyógyászati villamos készülékek. 2-30. rész: Automatikus, nem invazív vérnyomásmérők alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-30:2018)

Angol cím

Medical electrical equipment. Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2018)

Alkalmazási terület

Clause 1 of the general standard2 applies, except as follows: 201.1.1 Scope Replacement: This part of the 80601 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 non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This document 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 document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation 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 [2]. 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 document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. 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. 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, IEC 60601-1-6, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 apply as modified in Clauses 202, 206, 210, 211 and 212 respectively. IEC 60601-1-3 [3] does not apply. All other published collateral standards in the IEC 60601-1 series apply as published [1] [4]. Túl hosszú

ICS

11.040 Orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-01-01

Forrás

idt EN IEC 80601-2-30:2019; idt IEC 80601-2-30:2018

Előd

MSZ EN 80601-2-30:2011, MSZ EN 80601-2-30:2010/A1:2015

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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