EN 794-3:1998+A2:2009

Foreword
Introduction
Section one. General
1 Scope
2 Normative references
3 Terminology and definitions
4 General requirements and general requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
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
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
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 ultra-sonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking, accompanying documents
39 Common requirements for Category AP and Category APG
   equipment
40 Requirements and test for Category AP equipment, parts
   and components thereof
41 Requirements and test for Category APG equipment, parts
   and components thereof
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
48 Biocompatibility
49 Interruption of the power supply
50 Accuracy of operating data
51 Protection against hazardous output
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
Annex AA (informative) - Rationale
Annex BB (normative) - Legibility and visibility
Annex CC (informative) - Bibliography
Annex DD (normative) - Special national conditions
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         93/42/EEC

The scope given in clause 1 of EN 60601-1:1990 applies with the following addition:1.101 R)This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use.This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. !This includes gas-powered resuscitators, which are generally used by first responders."This part does not cover operator-powered ventilators (i.e. manual resuscitators).Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations.Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.