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Current Base Standard (Based on Ed. 2)
IEC 60601-1 Ed.2 (12/1998) + Am 1 (11/91) + Am. 2 (03/95).
National Deviations:
USA: UL 60601-1 Ed.1 (4/25/2003) - for Ed.2
EU: EN 60601-1 (8/1990) + Am.1 (5/1993) + Am.2 (6/1995) + Am.11
(5/1993) + Am.12 (5/1993) + Am.13 (1/1996)
CANADA: CSA C22.2 No. 601.1-M90 (11/2003)
New Standard (Effective date June, 2012+)
IEC 60601-1 (2005-12) Ed.3, Corr.1 (2006-12), Corr.2 (2007-12), IS1
(2008-04), Am.1 (Project)
National Deviations:
USA: AAMI/ANSI ES60601-1 (02/05)
EU: EN 60601-1 (7/2007)
CANADA: CSA-C22.2 No.60601-1:2008
IEC 60601-1-xx
1: Safety Requirements for Medical Electrical Systems.
Ed.2 (2000-12).
2: Electromagnetic Compatibility - Requirements and Tests
Ed.3 (2007-03), IS1 (2010-03), Ed.2 (Project).
3: Gen. Requirements for Radiation Protection in
Diagnostic X-ray Equipment Ed.2 (2008-01).
4: Programmable Electrical Medical Systems. Ed.1.1 (2000-04).
5: Image quality and dose for X-ray equipment (Cancelled).
6: Analysis, test and validation of human factors
compatibility Ed.1 (06/04), Ed.2 (2006-12), Ed.3: Ed.3 (2010-01).
7: General requirements for multiparameter patient
monitoring equipment (Cancelled).
8: Requirements/guidelines for alarms in Medical
Electrical Equipment. Ed.1 (2003-08), Ed.2 (2006-10), Am.1 (Project).
9: Requirements for the reduction of environmental
impacts. Ed.1 (2007-07).
10: Process requirements for the development of
therapeutic closed-loop controllers Ed.1 (2007-11).
11: Medical Electrical Equipment for Use in Home Care
Applications (Project).
IEC 60601-2-xx
1: Medical Electron Accelerators in the Range 1 MeV to 50
MeV. Ed.2 (1998-06) Am.1 (2002-05), Ed.3: Ed.3 (2009-10).
2: High Frequency Surgical Equipment. Ed.4
(2006-07), Ed.3: Ed.5 (2009-03). [AAMI HF18-331].
3: Short-Wave Therapy Equipment. Ed. 2 (1991-06), Am.1
(1998-09), Ed.3 (Project).
4: Cardiac Defibrillators, Defibrillator-Monitors. Ed.2
(2002-08), Corr.1 (2004-04), Ed.3 (Project). [AAMI DF2-331].
5: Ultrasonic Therapy Equipment. Ed.2 (2000-07), Ed.3:
Ed.3 (2009-07).
6: Microwave Therapy Equipment.. Ed.1 (1984-01), Ed.2 (Project).
7: High Voltage Generators of Diagnostic X-ray
Generators. Ed. 2 (1998-02).
8: Therapeutic X-ray Equipment in the Range 10 kV to 1
MV. Ed.1.1 Consolidated (1999-04), Ed.2 (Project).
9: ??? Patient Contact Dosimeters used in Radiotherapy
with Electrically Connected Radiation Detectors. Ed. 2 (1996-10).
10: Nerve and Muscle Stimulators. Ed.1 (1987-12), Am.1
(2001-09), Corrigendum (2002-02), Ed.2 (Project).
11: Gamma Beam Therapy Equipment.. Ed.2 (1997-08) Am.1
(2004-07), Ed.3 (Project).
12: Lung Ventilators for Medical Use. Ed.2 (2001-10).
13: Anesthetic Machines. Ed.3 (2003-05), Am.1 (2006-05), Ed.3.1 (2009-08).
14: Electroconvulsive Therapy Equipment (1989-03) (Withdrawn).
15: Capacitor Discharge X-ray Generators (1988-12) (Withdrawn).
16: Hemodylysis Equipment. Ed. 3 (2008-04), Corr.1 (2008-10).
[AAMI RD16-331].
17: Remote-Controlled Automatically-Driven Gamma-ray
Afterloading Equipment. Ed..2 (2004-01), Ed.3 (Project).
18: Endoscopic Equipment. Ed. 2 (1996-08), Am.1
(2000-07), Ed.3: Ed.2 (2009-02), Ed.3: Ed.3 (2009-08).
19: Baby Incubators. Ed.1 (1990-12), Am.1 (1996-10), Ed.3: Ed.2
(2009-02). [AAMI II36-331].
20: Transport Incubators. Ed.1 (12/90), Am.1 (1996-10), Ed.3:
Ed.2 (2009-02). [AAMI II51-331].
21: Infant Radiant Warmers. Ed.1 (02/94), Am.1 (1996-10), Ed.3:
Ed.2 (2009-02).
22: Diagnostic and Therapeutic Laser Equipment. Ed. 2
(1995-11), Ed.3: Ed. 3 (2007-05).
23: Transcutaneous Partial Pressure Monitoring Equipment. Ed. 2
(1999-12), Ed.3 (Project).
24: Infusion Pumps and Controllers. Ed.1 (1998-02), Ed.2 (Project).
25: Electrocardiographs. Ed.1 (1993-03), Am.1 (1999-05), Ed.2
(Project). [AAMI EC11-331].
26: Electroencephalographs. Ed.2 (2002-11), Ed.3 (Project).
27: Electrocardiographic Monitoring Equipment. Ed.2 (2005-08),
Ed.3 (Project). [AAMI EC13-331].
28: X-ray Source Assemblies and X-ray Tube Assemblies for
Medical Diagnosis. Ed.1 (1993-03), Ed.3: Ed.2 (2010-03).
29: Radiotherapy Stimulators. Ed. 2 (1999-01), Ed.3 (2008-06).
30: Automatic Cycling Indirect Blood Pressure Monitoring
Equipment. Ed.2 (1999-12) (Moving to IEC 80601-2-30). [AAMI SP10].
31: External Cardiac Pacemakers with Internal Power Source.
Ed.1 (1994-10), Am.1 (1998-01), Ed.2 (2008-03).
32: Associated Equipment of X-ray Equipment. Ed.1 (1994-03).
33: Magnetic Resonance Equipment for Medical Diagnosis. Ed.2.1
(2006-02), Ed.2.2 (2008-04), Ed.3: Ed.3 (2010-03).
34: Direct Blood Pressure Monitoring Equipment. Ed.2 (2000-10),
Ed.3 (Project). [AAMI BP22-331]. [AAMI SP9-331].
35: Blankets, Pads and Mattresses Intended for Heating in
Medical Use. Ed.1 (1996-11), (Moving to IEC 80601-2-35).
36: Extracorporeally Induced Lithotripsy. Ed.1 (1997-03).
37: Ultrasonic Diagnostic and Monitoring Equipment. Ed.1
(2001-07), Am.1 (2004-08), Am.2 (2005-11), Ed.3: Ed.2 (2007-08).
38: Electrically Operated Hospital Beds. (1996-10), Am.1
(1999-12), (Moved to IEC 60601-2-52 for Ed.3).
39: Peritoneal Dialysis Equipment. Ed.1 (1999-06) Ed.2 (2007-11).
40: Electromyographs and Evoked Response Equipment. Ed.1 (1998-02).
41: Surgical Luminaires and Luminaires for Diagnosis. Ed.1
(02/00), Ed.3: Ed.2 (2009-08).
42: Automatic or Advisory External Defibrillators (Incorporated
into IEC 60601-2-4).
43: X-ray Equipment for Interventional Procedures. Ed.1
(2000-06), Ed.2 (Project).
44: X-ray Equipment for Computed Tomography. Ed.2 (2001-06),
Am.1 (2002-09) Ed.2.1 (2002-11), Ed.3 (2009-02).
45: Mammographic X-ray Equipment and Mammographic Stereotactic
Devices. Ed.2 (2001-05), Ed.3 (Project).
46: Operating Tables. Ed.1 (1998-06), Ed.2 (Project).
47: Ambulatory Electrocardiographic Monitors [Holter Monitors].
Ed.1 (2001-07), Ed.2 (Project).
48: Canceled
49: Multiparameter Patient Monitoring Equipment. Ed.1
(2001-07), Ed.2 (Project).
50: Infant phototherapy equipment. Ed.1 (2000-07), Corrigendum
1 (2001-03), Ed.2 (2009-03).
51: Recording and analyzing single and Multichannel
electrocardiographs. Ed.1 (2003-02).
52: Safety of Medical Beds. (To replace IEC 60601-2-38) Ed.3:
Ed.1 (2009-12).
53: Computer Assisted Electrocardiography Communication
Protocol. Ed.1 (Project).
54: X-ray equipment for radiography and radioscopy Ed.3: Ed.1
(2009-06), Corr.1 (2010-03).
55: Respiratory Gas Monitoring Equipment. Ed.1 (Project).
56: Clinical Thermometers for Body Temperature Measurement.
(Moved to ISO 80601-2-56).
57: Non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use. Ed.1 (Project)
58: Lens Removal and Vitrectomy Devices for Ophthalmic Surgery.
Ed.1 (Project).
59: Screening Thermographs for Human Febrile Temperature
Screening. (Moved to IEC 80601-2-59)
62: High intensity therapeutic ultrasound (HITU) systems. Ed.1 (Project).
63: Dental X-ray equipment. Ed.1 (Project).
64: Medical light ion accelerators in the range 10 MeV/n to 500
MeV/n. Ed.1 (Project).
XX: Treadmill and Crank Ergometers. Ed.1 (Project).
IEC 60601-3-xx
1: Transcutaneous oxygen and carbon dioxide partial
pressure monitoring equipment, Ed.1 (1996-08)
IEC 80601-2-xx
30: Automated non-invasive sphygmomanometers. Ed.1 (2009-01)
35: Heating devices using blankets, pads and mattresses and
intended for heating in medical use. Ed.2 (2009-10)
58: Lens removal devices and vitrectomy devices for ophthalmic
surgery. Ed.1 (2008-10)
59: Screening thermographs for human febrile temperature
screening, Ed.1 (2008-10)
ISO 80601-2-xx
56: Clinical thermometers for body temperature measurement,
Ed.1 (2009-12)
Other Related Standards:
IEC 60529: Protection provided by Enclosures - IPXX Rating
Ed.2.1 (02/01), Cor.1 (01/03).
IEC 60825-1: Safety of LASER Products - Part 1. Ed. 1.2 (08/01).
IEC 60878: Graphic Symbols for Electrical Equipment in Medical
Practice Ed.2 (07/03).
IEC 62353: Recurrent test and test after repair of medical
electrical equipment (Project)
IEC 62354 TR: General testing procedures for medical equipment (Project)
ISO 10993-1: Biological Evaluation of Medical Devices
[Biocompatibility] (08/03).
ISO 14971: Medical Devices - Application of Risk Management to
Medical Devices (12/00), Am.1 (03/03).
ANSI / UL1998: Software in Programmable Components Ed.2
(05/98), Am.1 (05/00), Rev.1 (05/04)
AAMI SP10: Manual/Electronic/Automated Sphygmomanometers (NIBP). Ed.2
(2002), Am. 1 (2003), Ed.4 (Project).
CSA C22.2 No. 0.4-M1982: Bonding and Grounding of Electrical
Equipment (Protective Grounding) (12/82).
ASTM F2196-02: Circulating Liquid and Forced Air Patient
Temperature Management Devices (10/02).
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