Hivatkozási szám

MSZ EN IEC 80601-2-49:2020

Dokumentumazonosító

175265

Cím

Gyógyászati villamos készülékek. 2-49. rész: Többfunkciós páciensmegfigyelő berendezések alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-49:2018)

Angol cím

Medical electrical equipment. Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (IEC 80601-2-49:2018)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS. NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT. This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply. EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies. EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependent PATIENT where ISO 80601-2-72 also applies. EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies. EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment, IEC 60601-2-16 also applies. This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS. 201.1.2 Object Replacement: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MULTIFUNCTION PATIENT MONITORS 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 60601-1-2:2014, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, as well as IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. Túl hosszú scope

ICS

11.040.55 Diagnosztikai készülékek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-07-01

Forrás

idt EN IEC 80601-2-49:2019; idt IEC 80601-2-49:2018

Előd

MSZ EN 60601-2-49:2016

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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