EN ISO 11197:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 11197:2016)
20-12-2019
09-03-2016
European foreword
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS
202 MEDICAL ELECTRICAL EQUIPMENT - part 1-2 General requirements
for BASIC SAFETY and ESSENTIAL PERFORMANCE - Collateral
standard: Electromagnetic disturbances - Requirements and
tests
206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6 General requirements
for BASIC SAFETY and ESSENTIAL PERFORMANCE - Collateral
standard: Usability
Annex AA (informative) - Rationale
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services. NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.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 IEC 60601-1:2005+A1:2012 (see 201.1.4).NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 793. (02/2005) Supersedes PREN ISO 11197. (03/2016)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| PN EN ISO 11197 : 2016 | Identical |
| VDE 0750-211 : 2016 | Identical |
| ISO 11197:2016 | Identical |
| UNI EN ISO 11197:2016 | Identical |
| I.S. EN ISO 11197:2016 | Identical |
| ONORM EN ISO 11197 : 2016 | Identical |
| SS-EN ISO 11197:2016 | Identical |
| NS EN ISO 11197 : 2016 | Identical |
| UNI EN ISO 11197 : 2009 | Identical |
| SN EN ISO 11197 : 2016 | Identical |
| DIN EN ISO 11197 : 2016 | Identical |
| NEN EN ISO 11197 : 2016 | Identical |
| BS EN ISO 11197:2009 | Identical |
| NBN EN ISO 11197 : 2016 | Identical |
| UNE-EN ISO 11197:2016 | Identical |
| NF EN ISO 11197 : 2016 | Identical |
| BS EN ISO 11197:2016 | Identical |
| BS EN 13718-1:2014 | Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
| EN 60601-2-16:2015 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| 04/30088537 DC : DRAFT SEP 2004 | PREN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
| 13/30276231 DC : 0 | BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| UNI EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| DIN EN 1789:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| DIN EN 13718-1:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| BS EN 60601-2-16:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| UNE-HD 60364-7-710:2014 | Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations |
| I.S. EN 1789:2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
| BS EN 1789 : 2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| I.S. EN 13718-1:2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| UNE-EN 1789:2007 | Medical vehicles and their equipment - Road ambulances |
| I.S. HD 60364-7-710:2012 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS (IEC 60364-7-710:2002 (MOD)) |
| HD 60364-7-710:2012/AC:2013 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS |
| UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| 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 |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| ISO 16571:2014 | Systems for evacuation of plume generated by medical devices |
| 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 |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 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 |
| 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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