PREN ISO 11197 : DRAFT 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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)
01-03-2016
12-01-2013
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Superseded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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.