I.S. EN 60601-1-2:2015

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MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS

Publisher: National Standards Authority of Ireland

Published: 01-01-2015

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National Foreword
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT and ME SYSTEMS identification,
   marking and documents
6 Documentation of the tests
7 ELECTROMAGNETIC EMISSIONS requirements for
  ME EQUIPMENT and ME SYSTEMS
8 Electromagnetic IMMUNITY requirements for ME
  EQUIPMENT and ME SYSTEMS
9 Test report
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Guidance in classification according
        to CISPR 11
Annex D (informative) - Guidance in the application of
        IEC 60601-1-2 to particular standards
Annex E (informative) - Determination of IMMUNITY TEST
        LEVELS for SPECIAL ENVIRONMENTS
Annex F (informative) - RISK MANAGEMENT for BASIC
        SAFETY and ESSENTIAL PERFORMANCE
        with regard to ELECTROMAGNETIC DISTURBANCES
Annex G (informative) - Guidance: Test plan
Annex H (informative) - PATIENT-coupled cables
        EMISSIONS
Annex I (informative) - Identification of IMMUNITY pass/fail
        criteria
Bibliography
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Abstract - (Show below) - (Hide below)

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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Published
Document Type	Standard
Status	Current
Publisher	National Standards Authority of Ireland
Pages
ISBN

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
SN EN 60601-1-2 : 2015	Identical
NF EN 60601-1-2 : 2016	Identical
EN 60601-1-2 : 2015	Identical
UNE EN 60601-1-2 : 2008	Identical
BS EN 60601-1-2 : 2015	Identical
SN EN 60601-1-2 : 2015	Identical
DIN EN 60601-1-2 : 2006-10	Identical
NF EN 60601-1-2 : 2016	Identical
UNE EN 60601-1-2 : 2008	Identical
UNE-EN 60601-1-2:2008	Identical
BS EN 60601-1-2 : 2015	Identical

Standards Referencing This Book - (Show below) - (Hide below)

IEC 61000-4-8 : 2.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
CISPR 14-1 : 6.0	ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS FOR HOUSEHOLD APPLIANCES, ELECTRIC TOOLS AND SIMILAR APPARATUS - PART 1: EMISSION
ISO/IEC 17025 : 2005	GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
IEC 60601-2-3 : 3.1	MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT
IEC 61000-3-11 : 2.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-11: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS - EQUIPMENT WITH RATED CURRENT <= 75 A AND SUBJECT TO CONDITIONAL CONNECTION
IEC 61000-1-1 : 1.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 1: GENERAL - SECTION 1: APPLICATION AND INTERPRETATION OF FUNDAMENTAL DEFINITIONS AND TERMS
IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION)	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
IEC 61000-2-5 : 3.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - ENVIRONMENT - CLASSIFICATION OF ELECTROMAGNETIC ENVIRONMENTS BASIC EMC PUBLICATION
EN 61000-4-11 : 2004 AMD 1 2017	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-11: TESTING AND MEASUREMENT TECHNIQUES - VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TESTS (IEC 61000-4-11:2004/A1:2017)
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
CISPR 16-1-1 : 4.0	SPECIFICATION FOR RADIO DISTURBANCE AND IMMUNITY MEASURING APPARATUS AND METHODS - PART 1-1: RADIO DISTURBANCE AND IMMUNITY MEASURING APPARATUS - MEASURING APPARATUS
IEC 61000-4-11 : 2.1	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-11: TESTING AND MEASUREMENT TECHNIQUES - VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TESTS
EN 61000-3-3 : 2013	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION (IEC 61000-3-3:2013)
IEC TS 61000-1-2 : 2.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 1-2: GENERAL - METHODOLOGY FOR THE ACHIEVEMENT OF FUNCTIONAL SAFETY OF ELECTRICAL AND ELECTRONIC SYSTEMS INCLUDING EQUIPMENT WITH REGARD TO ELECTROMAGNETIC PHENOMENA
IEC 60788 : 2.0	MEDICAL ELECTRICAL EQUIPMENT - GLOSSARY OF DEFINED TERMS
ISO 11451-3 : 2015	ROAD VEHICLES - VEHICLE TEST METHODS FOR ELECTRICAL DISTURBANCES FROM NARROWBAND RADIATED ELECTROMAGNETIC ENERGY - PART 3: ON-BOARD TRANSMITTER SIMULATION
ISO 7637-2 : 2011	ROAD VEHICLES - ELECTRICAL DISTURBANCES FROM CONDUCTION AND COUPLING - PART 2: ELECTRICAL TRANSIENT CONDUCTION ALONG SUPPLY LINES ONLY
IEC 61000-6-1 : 3.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-1: GENERIC STANDARDS - IMMUNITY STANDARD FOR RESIDENTIAL, COMMERCIAL AND LIGHT-INDUSTRIAL ENVIRONMENTS
ANSI C63.4 : 2014	METHODS OF MEASUREMENT OF RADIO-NOISE EMISSIONS FROM LOW-VOLTAGE ELECTRICAL AND ELECTRONIC EQUIPMENT IN THE RANGE OF 9 KHz TO 40 GHz
IEC 61000-3-12 : 2.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-12: LIMITS - LIMITS FOR HARMONIC CURRENTS PRODUCED BY EQUIPMENT CONNECTED TO PUBLIC LOW-VOLTAGE SYSTEMS WITH INPUT CURRENT > 16 A AND <= 75 A PER PHASE
EN 61000-4-2 : 2009	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST
IEC 60601-1-12 : 1ED 2014	MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
CISPR 32 : 2.0EN+(REDLINE+VERSION)	ELECTROMAGNETIC COMPATIBILITY OF MULTIMEDIA EQUIPMENT - EMISSION REQUIREMENTS
IEC 60601-1-8 : 2.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
EN 55032 : 2015 COR 2016	ELECTROMAGNETIC COMPATIBILITY OF MULTIMEDIA EQUIPMENT - EMISSION REQUIREMENTS (CISPR 32:2015/COR1:2016)
IEC 61000-4-6 : 4.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
EN 61000-4-3 : 2006 AMD 2 2010	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
IEC 60601-1-2 : 4.0	MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
CISPR 25 : 4.0:2016	VEHICLES, BOATS AND INTERNAL COMBUSTION ENGINES - RADIO DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT FOR THE PROTECTION OF ON-BOARD RECEIVERS
IEC 60601-2-2 : 6.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY SURGICAL ACCESSORIES
ISO TR 16142 : 2006	MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES
ANSI C63.14 : 2014	DICTIONARY OF ELECTROMAGNETIC COMPATIBILITY (EMC) INCLUDING ELECTROMAGNETIC ENVIRONMENTAL EFFECTS (E3)
ISO 14708-3 : 2017	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
93/42/EEC : 1993 AMD 5 2007	COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
MIL STD 461 : G	REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
EN 61000-4-8 : 2010	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
EN 55011 : 2016 AMD 1 2017	INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT (CISPR 11:2015/A1:2016)
IEC 61000-4-2 : 2.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST
IEC 61000-4-3 : 3.2	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
IEC 60601-2-27 : 3.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
CISPR 16-2-3 : 4.0	SPECIFICATION FOR RADIO DISTURBANCE AND IMMUNITY MEASURING APPARATUS AND METHODS - PART 2-3: METHODS OF MEASUREMENT OF DISTURBANCES AND IMMUNITY - RADIATED DISTURBANCE MEASUREMENTS
EN 61000-3-2 : 2014	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE) (IEC 61000-3-2:2014)
IEC 61496-1 : 3.0	SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
IEC 60050-161 : 1.0T	INTERNATIONAL ELECTRO-TECHNICAL VOCABULARY - ELECTROMAGNETIC COMPATIBILITY
ISO 11452-9 : 2012	ROAD VEHICLES - COMPONENT TEST METHODS FOR ELECTRICAL DISTURBANCES FROM NARROWBAND RADIATED ELECTROMAGNETIC ENERGY - PART 9: PORTABLE TRANSMITTERS
EN 55103-2 : 2009	ELECTROMAGNETIC COMPATIBILITY - PRODUCT FAMILY STANDARD FOR AUDIO, VIDEO, AUDIO-VISUAL AND ENTERTAINMENT LIGHTING CONTROL APPARATUS FOR PROFESSIONAL USE - PART 2: IMMUNITY
EN ISO 14971 : 2012	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
ISO 11452-8 : 2015	ROAD VEHICLES - COMPONENT TEST METHODS FOR ELECTRICAL DISTURBANCES FROM NARROWBAND RADIATED ELECTROMAGNETIC ENERGY - PART 8: IMMUNITY TO MAGNETIC FIELDS
ISO 7137 : 1995(R2018)	AIRCRAFT - ENVIRONMENTAL CONDITIONS AND TEST PROCEDURES FOR AIRBORNE EQUIPMENT
EN 60601-1:2006/A1	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005)
IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION)	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION
EN 61000-4-4 : 2012	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012)
CISPR 11 : 6.0EN+(REDLINE+VERSION)	INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
IEC 61000-4-5 : 2017-08	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-5: TESTING AND MEASUREMENT TECHNIQUES - SURGE IMMUNITY TEST
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CISPR 16-1-2 : 2.0EN+(REDLINE+VERSION)	SPECIFICATION FOR RADIO DISTURBANCE AND IMMUNITY MEASURING APPARATUS AND METHODS - PART 1-2: RADIO DISTURBANCE AND IMMUNITY MEASURING APPARATUS - COUPLING DEVICES FOR CONDUCTED DISTURBANCE MEASUREMENTS
IEC 61000-6-2 : 3.0:2016	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS
EN 60601-1-11 : 2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
CISPR 24 : 2.1	INFORMATION TECHNOLOGY EQUIPMENT - IMMUNITY CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
IEC 61000-4-13 : 1.2	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-13: TESTING AND MEASUREMENT TECHNIQUES - HARMONICS AND INTERHARMONICS INCLUDING MAINS SIGNALLING AT A.C. POWER PORT, LOW FREQUENCY IMMUNITY TESTS
EN 55014-1 : 2017	ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS FOR HOUSEHOLD APPLIANCES, ELECTRIC TOOLS AND SIMILAR APPARATUS - PART 1: EMISSION (CISPR 14-1:2016 + COR1:2016)
EN 60601-1-8 : 2007 AMD 11 2017	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
IEC 61000-3-2 : 4.0	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE)
IEC 60601-2-44 : 3.2	MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY

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I.S. EN 60601-1-2:2015

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