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

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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! The links below may not be to the version you require.

 

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! The links below may not be to the version you require.

IEC 60601-2-1

EN 60601-2-1

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance 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 basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-3

EN 60601-2-3

Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment

IEC 60601-2-4

EN 60601-2-4

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

IEC 60601-2-5

EN 60601-2-5

Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-6

EN 60601-2-6

Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance 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 basic safety and essential performance 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 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-11

EN 60601-2-11

Medical electrical equipment. Part 2-11. Particular requirements for basic safety and essential performance of gamma beam therapy equipment

ISO/IEC 80601-2-12

EN ISO 80601-2-12

Medical electrical equipment. Part 2-12. Particular requirements for basic safety and essential performance of critical care ventilators

ISO/IEC 80601-2-13

EN 60601-2-13

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration 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 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-19

EN 60601-2-19

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

IEC 60601-2-20

EN 60601-2-20

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC 60601-2-21

EN 60601-2-21

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

IEC 60601-2-22

EN 60601-2-22

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-23

EN 60601-2-23

Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

IEC 60601-2-24

EN 60601-2-24

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

IEC 60601-2-25

EN 60601-2-25

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-26

EN 60601-2-26

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

IEC 60601-2-27

EN 60601-2-27

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC 60601-2-28

EN 60601-2-28

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of 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 basic safety and essential performance of radiotherapy simulators

IEC 80601-2-30

EN 60601-2-30

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

IEC 60601-2-31

EN 60601-2-31

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance 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 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-34

EN 60601-2-34

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC 80601-2-35

EN 80601-2-35

Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

IEC 60601-2-36

EN 60601-2-36

Medical electrical equipment. Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy

IEC 60601-2-37

EN 60601-2-37

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic 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 basic safety and essential performance 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 basic safety and essential performance 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 basic safety and essential performance 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 basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-45

EN 60601-2-45

Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices

IEC 60601-2-46

EN 60601-2-46

Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables

IEC 60601-2-47

EN 60601-2-47

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

IEC 60601-2-49

EN 60601-2-49

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

IEC 60601-2-50

EN 60601-2-50

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance 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

IEC 60601-2-52

EN 60601-2-52

Medical electrical equipment -- Part 2-52: Particular requirements for basic safety and essential performance of medical beds

IEC 60601-2-54

EN 60601-2-54

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

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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.