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PREN ISO 11197 : DRAFT 2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012)

Superseded date

01-03-2016

Superseded by

EN ISO 11197:2016

Published date

12-01-2013

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Foreword
Introduction
1 Scope
Annex AA (informative) - Rationale
Annex BB (Informative) - Tests during production
Annex CC (informative) - Documentation
Bibliography
Index of defined terms used in this particular standard
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.

Committee
TC 215
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
12/30262133 DC : 0 Identical

EN 60446:2007 Basic and safety principles for man-machine interface, marking and identification - Identification of conductors by colours or alphanumerics
IEC 60364-5-54:2011 Low-voltage electrical installations - Part 5-54: Selection and erection of electrical equipment - Earthing arrangements and protective conductors
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
EN 50174-1:2009/A2:2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 1: INSTALLATION SPECIFICATION AND QUALITY ASSURANCE
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
EN 50174-2 : 2009 AMD 2 2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 2: INSTALLATION PLANNING AND PRACTICES INSIDE BUILDINGS
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60598-1:2014+AMD1:2017 CSV Luminaires - Part 1: General requirements and tests
IEC 60669-1:2017 Switches for household and similar fixed-electrical installations - Part 1: General requirements
EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
IEC 61386-1:2008+AMD1:2017 CSV Conduit systems for cable management - Part 1: General requirements
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
IEC 61950:2007 Cable management systems - Specifications for conduit fittings and accessories for cable installations for extra heavy duty electrical steel conduit
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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