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BS EN ISO 11197:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical supply units
Available format(s)

Hardcopy , PDF

Superseded date

05-08-2018

Language(s)

English

Published date

05-31-2009

Foreword
Introduction
SECTION ONE - GENERAL
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8 Basic safety categories
9 Removable protection means
10 Environmental conditions
11 Not Used
12 Not Used
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
   equalization
19 Continuous leakage current and patient auxiliary currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
               OR EXCESSIVE RADIATION
29 X-Radiation
30 Alpha, beta, gamma, neutron radiation and other particle
   radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
              FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements
38 Marking and accompanying documents
39 Common requirements for Category AP and Category APG
   Equipment
40 Requirements and tests for Category AP Equipment,
   parts and components thereof
41 Requirements and tests for Category APG Equipment,
   parts and components thereof
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                AND OTHER SAFETY HAZARDS
42 Excessive temperatures
43 R Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
   liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Material in applied parts in contact with the body of
   the patient
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
               ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - terminals and connections
59 Construction and layout
Annexes
Annex AA (normative) - Special National Conditions
Annex BB (informative) - Rationale
Annex ZB (Informative) - Normative references to
         international publications with their relevant
         European publications
Bibliography
Annex ZA (Informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Pertains to medical supply units.

Committee
CH/121/6
DevelopmentNote
Supersedes BS EN 793 & 02/561691 DC. (02/2005) To be read in conjunction with BS EN 60601-1. (06/2009)
DocumentType
Standard
Pages
52
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60364-5-51:2005 Electrical installations of buildings - Part 5-51: Selection and erection of electrical equipment - Common rules
ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 737-2:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
EN 61386-1:2008 Conduit systems for cable management - Part 1: General requirements
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
EN 60601-1-2:2015 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
EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
EN 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 (ISO 3744:2010)
IEC 60598-1:2014+AMD1:2017 CSV Luminaires - Part 1: General requirements and tests
DIN VDE 0107 : 1994 ELECTRICAL INSTALLATIONS IN HOSPITALS AND LOCATIONS FOR MEDICAL USE OUTSIDE HOSPITALS
IEC 60669-1:2017 Switches for household and similar fixed-electrical installations - Part 1: General requirements
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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
EN 737-4 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
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
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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