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The Medical Device Developer's Guide to IEC 60601-1

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Click here for the IEC 60601-1 Primer, by Leonard Eisner, Robert M. Brown and Dan Modi, as published in "Medical Device and Diagnostic Industry"

 

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The table below lists all of the IEC 60601-1-X standards, known as collateral standards. These standards cover subjects of interest to a range of electrical medical products.

You can purchase a standard from          

by clicking the standard you want.

Make sure that you choose the correct year and amendments!

 

IEC 60601-1-1

EN 60601-1-1

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

IEC 60601-1-2

EN 60601-1-2

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS

IEC 60601-1-3

EN 60601-1-3

MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT

IEC 60601-1-4

EN 60601-1-4

MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL REQUIREMENTS FOR COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

IEC 60601-1-6

EN 60601-1-6

MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD:USABILITY

IEC 60601-1-8

EN 60601-1-8

MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD:GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS

The table below lists all of the IEC 60601-2-X standards for particular types of medical equipment. The standards are used in conjunction with the basic standard IEC 60601-1, and follow the same clause numbering system. These standards amend the clauses of the basic standard.

You can purchase a standard from         

by clicking the standard you want.

Make sure that you choose the correct year and amendments!

 

IEC 60601-2-1

EN 60601-2-1

MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRON ACCELERATORS IN THE RANGE 1 MeV TO 50 MeV

IEC 60601-2-2

EN 60601-2-2

MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT

IEC 60601-2-3

EN 60601-2-3

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SHORT-WAVE THERAPY EQUIPMENT

IEC 60601-2-4

EN 60601-2-4

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS AND CARDIAC DEFIBRILLATORS - MONITORS

IEC 60601-2-5

EN 60601-2-5

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT

IEC 60601-2-6

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF MICROWAVE THERAPY EQUIPMENT

IEC 60601-2-7

EN 60601-2-7

MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS

IEC 60601-2-8

EN 60601-2-8

MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE SAFETY OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 kV TO 1 MV

IEC 60601-2-9

EN 60601-2-9

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITHELECTRICALLY CONNECTED RADIATION DETECTORS

IEC 60601-2-10

EN 60601-2-10

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF NERVE AND MUSCLE STIMULATORS

IEC 60601-2-11

EN 60601-2-11

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF GAMMA BEAM THERAPHY EQUIPMENT

IEC 60601-2-12

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF LUNG VENTILATORS FOR MEDICAL USE

IEC 60601-2-13

MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC WORKSTATIONS

IEC 60601-2-14

EN 60601-2-14

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF ELECTROCONVULSIVE THERAPY EQUIPMENT

IEC 60601-2-15

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF CAPACITOR DISCHARGE X-RAY GENERATORS

IEC 60601-2-16

EN 60601-2-16

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF HAEMODIALYSIS EQUIPMENT

IEC 60601-2-17

EN 60601-2-17

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF REMOTE-CONTROLLED AUTOMATICALLY DRIVEN GAMMA-RAY AFTER-LOADING EQUIPMENT

IEC 60601-2-18

EN 60601-2-18

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ENDOSCOPIC EQUIPMENT

IEC 60601-2-19

EN 60601-2-19

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS OF SAFETY OF BABY INCUBATORS

IEC 60601-2-20

EN 60601-2-20

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS

IEC 60601-2-21

EN 60601-2-21

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT RADIANT WARMERS

IEC 60601-2-22

EN 60601-2-22

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF DIAGNOSTIC AND THERAPEUTIC LASER EQUIPMENT

IEC 60601-2-23

EN 60601-2-23

MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF TRANSCUTANEOUSPARTIAL PRESSURE MONITORING EQUIPMENT

IEC 60601-2-24

EN 60601-2-24

MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARITCULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS

IEC 60601-2-25

EN 60601-2-25

MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCARDIOGRAPHS

IEC 60601-2-26

EN 60601-2-26

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROENCEPHALOGRAPHS

IEC 60601-2-27

EN 60601-2-27

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT

IEC 60601-2-28

EN 60601-2-28

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY SOURCE ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS

IEC 60601-2-29

EN 60601-2-29

MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPHY SIMULATORS

IEC 60601-2-30

EN 60601-2-30

MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

IEC 60601-2-31

EN 60601-2-31

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE

IEC 60601-2-32

EN 60601-2-32

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT

IEC 60601-2-33

EN 60601-2-33

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS

IEC 60601-2-34

EN 60601-2-34

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

IEC 60601-2-35

EN 60601-2-35

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE

IEC 60601-2-36

EN 60601-2-36

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY

IEC 60601-2-37

EN 60601-2-37

 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC MEDICAL DIAGNOSIC AND MONITORING EQUIPMENT

IEC 60601-2-38

EN 60601-2-38

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FORTHE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS

IEC 60601-2-39

EN 60601-2-39

MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PERITONEAL DIALYSIS EQUIPMENT

IEC 60601-2-40

EN 60601-2-40

MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELETROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT

IEC 60601-2-41

EN 60601-2-41

MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR THE SAFETY OF SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS

IEC 60601-2-43

EN 60601-2-43

MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES

IEC 60601-2-44

EN 60601-2-44

MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY

IEC 60601-2-45

EN 60601-2-45

MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES

IEC 60601-2-46

EN 60601-2-46

MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE SAFETY OF OPERATING TABLES

IEC 60601-2-47

EN 60601-2-47

MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS

IEC 60601-2-49

EN 60601-2-49

MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE SAFETY OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT

IEC 60601-2-50

EN 60601-2-50

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5O: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT PHOTOTHERAPY EQUIPMENT

IEC 60601-2-51

EN 60601-2-51

MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.