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BS EN 60601-2-12:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
Available format(s)

Hardcopy , PDF

Superseded date

09-30-2011

Language(s)

English

Published date

10-31-2006

FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
  1 Scope and object
  2 Terminology and definitions
  3 General requirements
  4 General requirements for tests
  5 Classification
  6 Identification, marking and documents
  7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
  8 Basic safety categories
  9 Removable protective means
  10 Environmental conditions
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 CURRENTS 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 Ultra-violet 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, 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 Fire prevention
  44 Overflow, spillage, leakage, humidity, ingress of liquids,
     cleaning, sterilization, disinfection and compatibility
  45 Pressure vessels and parts subject to pressure
  46 Human errors
  47 Electrostatic charges
  48 Biocompatibility
  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
  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
Appendix L References - Publications mentioned in this standard
Annex AA (informative) Rationale
Annex BB (normative) Legibility and visibility of visual indications
Annex CC (informative) Intelligent alarm systems
Bibliography
Terminology - Index of defined terms
Annex ZA (normative) Normative references to international
                       publications with their corresponding
                       European publications
Annex ZB (informative) References to international publications
                       with their corresponding European
                       publications
Annex ZZ (informative) Coverage of Essential Requirements
                       of EC Directives

Describes the safety requirements for VENTILATORS, as defined in 2.1.125, intended for use in critical care settings.

Committee
CH/121/5
DevelopmentNote
Supersedes BS EN 794-1 and BS 5724-2.202(1997). To be read in conjunction with BS EN 60601-1. (10/2006)
DocumentType
Standard
Pages
48
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
IEC 60416:1988 General principles for the formulation of graphical symbols
IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
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ISO 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
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ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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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
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ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
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ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 7396:1987 Non-flammable medical gas pipeline systems
IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
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ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
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ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
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ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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