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DS/EN ISO 11197

Medical supply units

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Organization: DS
Publication Date: 31 March 2016
Status: active
Page Count: 42
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site. NOTE - The definition of a MANUFACTURER and guidance on assembly on site can be found in ISO 14971 and ISO 13485. HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE - See also 4.2 of the General Standard.

Document History

April 6, 2018
Medical supply units (ISO/FDIS 11197:2019)
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT....
April 6, 2018
Medical supply units (ISO/DIS 11197:2018)
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT....
DS/EN ISO 11197
March 31, 2016
Medical supply units
201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International...
June 3, 2009
Medical supply units
ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic...
February 2, 2005
Medical supply units
This document applies to medical supply units. This particular document applies in conjunction with EN 60601-1
Medical supply units (ISO 11197:2004)
ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic...
Medical supply units (ISO/FDIS 11197:2015)
201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International...
Medical supply units (ISO/DIS 11197:2013)
201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International...
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