CSA C22.2 No. 60601.1.2 : 2016
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
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
English - French
Published date
07-01-2016
Publisher
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.
| DevelopmentNote |
Supersedes CSA C22.2.601.1.2 (07/2003) NEW CHILD AMD 1 2022 IS NOW ADDED
|
| DocumentType |
Standard
|
| Pages |
292
|
| ProductNote |
NEW CHILD AMD 1 2022 IS NOW ADDED
|
| PublisherName |
Canadian Standards Association
|
| Status |
Current
|
| Supersedes |
| CSA C22.2 No. 80601-2-35 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA Z10535.1 : 2015 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CSA Z10651.6 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z18778 : 2008 : R2018 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| CSA Z10535 : 2003 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CSA C22.2 No. 60601.2.13 : 2007 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| CSA Z10535 : 2003 : R2014 | HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
| CSA C22.2 No. 80601-2-35 : 2012(R2016) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA C22.2 No. 80601-2-69 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
| CSA C22.2 No. 80601-2-12 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 80601-2-35 : 2012 : INC : COR 1 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| CSA C22.2 No. 60601.2.34 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| CSA Z10651.6 : 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z18778 :2008 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| CSA C22.2 No. 60601.2.13 :2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| CSA C22.2 No. 80601-2-12 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 60601-2-25 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS |
| CSA Z18778 : 2008 : R2013 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| CSA Z8185 : 2008 | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| CSA Z32 : 2015 | ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES |
| CSA Z10651.2: 2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| Z317.5-17 | Illumination design in health care facilities |
| CSA Z10651.6 :2006 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
| CSA Z8185 : 2008(R2013) | RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
| CSA Z10651.2 : 2006 : R2015 | LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| 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 61000-1-2:2016 | 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 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 |
| 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 |
| C22.1-15 | Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations |
| 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 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 61000-3-12:2011 | 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CSA C22.2 No. 60601.1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| 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 |
US$290.03
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English - French
PDF - English - French
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.
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.