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

Current

Current The latest, up-to-date edition.

Preview

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:

Available Formats: PDF - English, Hardcopy - English
More Info on product formats

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Table of Contents - (Show below) - (Hide below)

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.

General Product Information - (Show below) - (Hide below)

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	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	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

Add To Cart

Product Format

Quantity

add to cart

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

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

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

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

Add To Cart

Publisher

Category

Sub Category

Access your standards online with a subscription?