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Current Base Standard:
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)
Japan: JSA JIS T0601-1 (12/27/1999).
Future Base Standard (Expected to be effective between 2009
and 2012):
IEC 60601-1 Ed.3 (12/2005).
National Deviations:
USA: AAMI/ANSI ES60601-1 (02/05) - for Ed.3
EU: EN 60601-1 (7/2007)
IEC 60601-1-xx
1: Safety Requirements for Medical Electrical Systems.
Ed.2 (12/00).
2: Electromagnetic Compatibility - Requirements and Tests
Ed.2.1 (11/04).
3: Gen. Requirements for Radiation Protection in
Diagnostic X-ray Equipment (07/94).
4: Programmable Electrical Medical Systems. Ed.1.1 (04/00).
5: Image quality and dose for X-ray equipment (Project).
6: Analysis, test and validation of human factors
compatibility Ed.1 (06/04), Ed.2 (12/06).
7: General requirements for multiparameter patient
monitoring equipment (Cancelled).
8: Requirements/guidelines for alarms in Medical
Electrical Equipment. Ed.1 (08/05), Ed.2 (10/06).
9: Requirements for the reduction of environmental
impacts. Ed.1 CD (10/04).
10: Process requirements for the development of therapeutic
closed-loop controllers (Project 07/04).
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 (06/98) Am.1 (05/02).
2: High Frequency Surgical Equipment. Ed. 3 (09/98)
Ed.4 (07/06). [AAMI HF18-331].
3: Short-Wave Therapy Equipment. Ed. 2 (06/91), Am.1
(09/98) Ed.2 (Project).
4: Cardiac Defibrillators, Defibrillator-Monitors. Ed.2
(08/02), Corr.1 (04/04), Ed.3 CD (Project. [AAMI DF2-331].
5: Ultrasonic Therapy Equipment. Ed.2 (07/00).
6: Microwave Therapy Equipment.. Ed.1 (01/84).
7: High Voltage Generators of Diagnostic X-ray
Generators. Ed. 2 (02/98).
8: Therapeutic X-ray Equipment in the Range 10 kV to 1
MV. Ed.1.1 Consolidated (04/99).
9: Patient Contact Dosimeters used in Radiotherapy with
Electrically Connected Radiation Detectors. Ed. 2 (10/96).
10: Nerve and Muscle Stimulators. Ed.1 (12/87), Am.1 (09/01),
Corrigendum (02/02).
11: Gamma Beam Therapy Equipment.. Ed.1 (08/97) Am.1 (07/04).
12: Lung Ventilators for Medical Use. Ed.2 (10/01).
13: Anesthetic Machines. Ed.3 (05/03), Am.1 (05/06).
14: Electroconvulsive Therapy Equipment (03/89) (Withdrawn).
15: Capacitor Discharge X-ray Generators (12/88) (Withdrawn).
16: Hemodylysis Equipment. Ed. 2 (02/98), Ed.3 CD (02/05).
[AAMI RD16-331].
17: Remote-Controlled Automatically-Driven Gamma-ray
Afterloading Equipment. Ed..2 (01/04) Cor (09/05).
18: Endoscopic Equipment. Ed. 2 (08/96), Am.1 (07/00).
19: Baby Incubators. Ed.1 (12/90), Am.1 (10/96). [AAMI II36-331].
20: Transport Incubators. Ed.1 (12/90), Am.1 (10/96). [AAMI II51-331].
21: Infant Radiant Warmers. Ed.1 (02/94), Am.1 (10/96).
22: Diagnostic and Therapeutic Laser Equipment. Ed. 2 (11/95),
Ed. 3 (Project).
23: Transcutaneous Partial Pressure Monitoring Equipment. Ed. 2 (12/99).
24: Infusion Pumps and Controllers. Ed.1 (02/98).
25: Electrocardiographs. Ed.1 (03/93), Am.1 (05/99). [AAMI EC11-331].
26: Electroencephalographs. Ed.1 (04/94), Ed.2 (11/02).
27: Electrocardiographic Monitoring Equipment. Ed.1 (04/94),
Ed.2 (08/05). [AAMI EC13-331].
28: X-ray Source Assemblies and X-ray Tube Assemblies for
Medical Diagnosis. Ed.1 (03/93).
29: Radiotherapy Stimulators. Ed. 2 (01/99).
30: Automatic Cycling Indirect Blood Pressure Monitoring
Equipment. Ed.2 (12/99). [AAMI SP10-331].
31: External Cardiac Pacemakers with Internal Power Source.
Ed.1 (10/94), Am.1 (01/98).
32: Associated Equipment of X-ray Equipment. Ed.1 (03/94).
33: Magnetic Resonance Equipment for Medical Diagnosis. Ed.2
(05/02), Ed.2.1 (02/06).
34: Direct Blood Pressure Monitoring Equipment. Ed.2
(10/00). [AAMI BP22-331]. [AAMI SP9-331].
35: Blankets, Pads and Mattresses Intended for Heating in
Medical Use. Ed.1 (11/96).
36: Extracorporeally Induced Lithotripsy. Ed.1 (03/97).
37: Ultrasonic Medical Diagnostic and Monitoring Equipment.
Ed.1 (07/01), Am.1 (08/04), Am.2 (11/05).
38: Electrically Operated Hospital Beds. (10/96), Am.1 (12/99),
(Changing to IEC 60601-2-52).
39: Peritoneal Dialysis Equipment. Ed.1 (06/99) Ed.2 CD (03/05).
40: Electromyographs and Evoked Response Equipment. Ed.1 (02/98).
41: Surgical Luminaires and Luminaires for Diagnosis. Ed.1
(02/00), Ed.2 CD (09/06).
42: Automatic or Advisory External Defibrillators (Incorporated
into IEC 60601-2-4).
43: X-ray Equipment for Interventional Procedures. Ed.1 (06/00).
44: X-ray Equipment for Computed Tomography. Ed.2 (06/01), Am.1
(09/02) Ed.2.1 (11/02).
45: Mammographic X-ray Equipment and Mammographic Stereotactic
Devices. Ed.2 (05/01).
46: Operating Tables. Ed.1 (06/98).
47: Ambulatory Electrocardiographic Monitors [Holter Monitors].
Ed.1 (07/01).
48: Canceled
49: Multiparameter Patient Monitoring Equipment. Ed.1 (07/01).
50: Infant phototherapy equipment. Ed.1 (07/00), Corrigendum 1 (03/01).
51: Recording and analyzing single and Multichannel
electrocardiographs. Ed.1 (02/03).
52: Safety of Medical Beds. (To replace IEC 60601-2-38) Ed.1 CD (01/05).
53: Computer Assisted Electrocardiography Communication
Protocol. Ed.1 (Project).
54: Pulse Oximeters Ed.1 (Project?).
55: Respiratory Gas Monitoring Equipment. Ed.1 CD (11/02).
56: Clinical Thermometers for Body Temperature Measurement. Ed.1 (Project)
58: Lens Removal and Vitrectomy Devices for Ophthalmic Surgery. Ed.1 (Project)
59: Screening Thermographs for Human Febrile Temperature Screening.
XX: Treadmill and Crank Ergometers. Ed.1 (Project).
Other Related Standards:
IEC 60529: Protection provided by Enclosures - IPXX Rating
Ed.2.1 (02/01), Cor.1 (01/03).
ISO 10993-1: Biological Evaluation of Medical Devices
[Biocompatibility] (08/03).
IEC 60825-1: Safety of LASER Products - Part 1. Ed. 1.2 (08/01).
ANSI / UL1998: Software in Programmable Components Ed.2
(05/98), Am.1 (05/00), Rev.1 (05/04)
ISO 14971: Medical Devices - Application of Risk Management to
Medical Devices (12/00), Am.1 (03/03).
IEC 62353: Recurrent test and test after repair of medical
electrical equipment (Project)
IEC 62354 TR: General testing procedures for medical equipment (Project)
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).
IEC 60878: Graphic Symbols for Electrical Equipment in Medical
Practice Ed.2 (07/03).
ASTM F2196-02: Circulating Liquid and Forced Air Patient
Temperature Management Devices (10/02).
UL 544: Medical and Dental Equipment (Equipment Freeze Date
1/1/2005), (Standard Withdraw Date 1/1/2010)
UL 187: X-Ray Equipment (Equipment Freeze Date 1/1/2005),
(Standard Withdraw Date 1/1/2010)
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