SN EN 60601-2-12 : 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.