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IEC
60601-1 Standards and Work in Progress
IEC
80601-1 Standards and Work in Progress
Current Base Standard (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 (Ed. 3):
(Europe / Canada required date: June, 2012, US required date: June,
2013, Other countries have not specified a date)
IEC 60601-1 (2005-12) Ed.3, Corr.1 (2006-12), Corr.2 (2007-12), 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
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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