• There are no items in your cart

ANSI/AAMI/IEC 60601-1-2:2014

Current
Current

The latest, up-to-date edition.

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

Hardcopy , PDF

Language(s)

English

Published date

05-09-2014

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
IEC 60601-1-2:2014
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

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.

Committee
EM
DevelopmentNote
New child AMD 1 2021 is added.
DocumentType
Standard
ISBN
157020524-8
Pages
142
ProductNote
New child AMD 1 2021 is added.
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
IEC 60601-1-2:2014 Identical
IEC 60601-1-2:2007 Identical

ISO/IEC TR 20017:2011 Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION
AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS
AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS

IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
CISPR 14-1:2016 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
CFR 21(PTS1300-END) : 0 FOOD AND DRUGS
IEC 60601-2-3:2012+AMD1:2016 CSV 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
CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
IEC TR 61000-1-1:1992 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 61000-6-2:2016 Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments
CFR 21(PTS170-199) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
CISPR 16-1-1:2015 Specification for radio disturbance and immunity measuring apparatus and methods - Part 1-1: Radio disturbance and immunity measuring apparatus - Measuring apparatus
IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
IEC TS 61000-1-2:2008 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 TR 60788:2004 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
IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
IEC 61000-3-12:2011 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
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
CISPR 32:2015 RLV Electromagnetic compatibility of multimedia equipment - Emission requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC TR 61000-2-5:2017 Electromagnetic compatibility (EMC) - Part 2-5: Environment - Description and classification of electromagnetic environments
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
IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CISPR 25:2016 Vehicles, boats and internal combustion engines - Radio disturbance characteristics - Limits and methods of measurement for the protection of on-board receivers
IEC 60601-2-2:2017 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
CFR 21(PTS100-169) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 100-169
CFR 21(PTS500-599) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 500-599
AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
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
IEEE/ANSI C63.14-2014 REDLINE American National Standard 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
MIL-STD-461 Revision G:2015 REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
CFR 21(PTS300-499) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
CISPR 16-2-3:2016 Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements
IEC 61000-3-3:2013 RLV 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 61000-6-1:2016 Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
IEC 61496-1:2012 Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests
ISO 11452-9:2012 Road vehicles Component test methods for electrical disturbances from narrowband radiated electromagnetic energy Part 9: Portable transmitters
CFR 21(PTS600-799) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799
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
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 Aircraft — Environmental conditions and test procedures for airborne equipment
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
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 61000-6-2 : 3.0:2016 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 6-2: GENERIC STANDARDS - IMMUNITY STANDARD FOR INDUSTRIAL ENVIRONMENTS
CISPR 24:2010+AMD1:2015 CSV Information technology equipment - Immunity characteristics - Limitsand methods of measurement
IEC 61000-4-13:2002+AMD1:2009+AMD2:2015 CSV Electromagnetic compatibility (EMC) - Part 4-13: Testing and measurement techniques - Harmonics and interharmonics includingmains signalling at a.c. power port, low frequency immunity tests
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 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEEE/ANSI C63.7-2015 American National Standard Guide for Construction of Test Sites for Performing Radiated Emission Measurements

View more information
US$370.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.