IEC 60601-2-12:2001

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 requirements
9 Removable protective means
10 Environmental conditions
12 SINGLE FAULT CONDITION
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 Insulation and PROTECTIVE IMPEDANCES
18 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 ultrasonic)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
              OF FLAMMABLE ANESTHETIC 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 and disinfection
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
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
Appendix L References - Publications mentioned in this
                        standard
APPENDIX AA (informative) Rationale
Annex BB (normative) Legibility and visibility of visual
                     indications
Annex CC (informative) Intelligent alarm systems
Bibliography
Terminology - Index of defined terms

Specifies the safety requirements for ventilators, as defined below, intended for use in critical care settings.Ventilator: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient.