Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators
DIN EN 794-3:2009-12 (E)
Lung ventilators – Part 3: Particular requirements for emergency and transport
ventilators (includes Amendment A2:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….4
Introduction ……………………………………………………………………………………………………………………………………5
Section one. General ………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..6
2 Normative references ……………………………………………………………………………………………………..6
3 Terminology and definitions ……………………………………………………………………………………………7
4 General requirements and general requirements for tests ………………………………………………..8
5 Classification ………………………………………………………………………………………………………………….9
6 Identification, marking and documents ……………………………………………………………………………9
7 Power input …………………………………………………………………………………………………………………..15
8 Basic safety categories …………………………………………………………………………………………………16
9 Removable protective means ………………………………………………………………………………………..16
10 Environmental conditions ……………………………………………………………………………………………..16
11 Not used ……………………………………………………………………………………………………………………….17
12 Not used ……………………………………………………………………………………………………………………….17
13 General …………………………………………………………………………………………………………………………18
14 Requirements related to classification …………………………………………………………………………..18
15 Limitation of voltage and/or energy ……………………………………………………………………………….18
16 Enclosures and protective covers ………………………………………………………………………………….18
17 Separation …………………………………………………………………………………………………………………….18
18 Protective earthing, functional earthing and potential equalization …………………………………18
19 Continuous leakage currents and patient auxiliary currents …………………………………………..18
20 Dielectric strength …………………………………………………………………………………………………………18
21 Mechanical strength ………………………………………………………………………………………………………19
22 Moving parts …………………………………………………………………………………………………………………20
23 Surfaces, corners and edges …………………………………………………………………………………………20
24 Stability in normal use …………………………………………………………………………………………………. 20
25 Expelled parts ……………………………………………………………………………………………………………… 20
26 Vibration and noise ……………………………………………………………………………………………………… 20
27 Pneumatic and hydraulic power …………………………………………………………………………………… 20
28 Suspended masses ……………………………………………………………………………………………………… 20
29 X-radiation …………………………………………………………………………………………………………………… 21
30 Alpha, beta, gamma, neutron radiation and other particle radiation ………………………………. 21
31 Microwave radiation …………………………………………………………………………………………………….. 21
32 Light radiation (including lasers) ………………………………………………………………………………….. 21
33 Infra-red radiation ………………………………………………………………………………………………………… 21
34 Ultra-violet radiation …………………………………………………………………………………………………….. 21
35 Acoustical energy (including ultra-sonics) ……………………………………………………………………. 21
36 Electromagnetic compatibility ……………………………………………………………………………………… 21
37 Locations and basic requirements ……………………………………………………………………………….. 23
38 Marking, accompanying documents …………………………………………………………………………….. 23
39 Common requirements for Category AP and Category APG equipment ………………………… 23
40 Requirements and test for Category AP equipment, parts and components thereof ………. 23
41 Requirements and test for Category APG equipment, parts and components thereof ……. 23
42 Excessive temperatures ………………………………………………………………………………………………. 24
43 R) Fire prevention ………………………………………………………………………………………………………… 24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection ………………………………………………………………………………………………………………….. 24
45 Pressure vessels and parts subject to pressure ……………………………………………………………. 24
46 Not used ……………………………………………………………………………………………………………………… 25
47 Not used ……………………………………………………………………………………………………………………… 25
48 Biocompatibility …………………………………………………………………………………………………………… 25
49 Interruption of the power supply ………………………………………………………………………………….. 25
50 Accuracy of operating data ………………………………………………………………………………………….. 26
51 Protection against hazardous output ……………………………………………………………………………. 26
52 Abnormal operation and fault conditions ……………………………………………………………………… 30
53 Environmental tests …………………………………………………………………………………………………….. 30
54 General …………………………………………………………………………………………………………………………31
55 Enclosures and covers ………………………………………………………………………………………………….31
56 Components and general assembly ……………………………………………………………………………….31
57 Mains parts, components and layout ……………………………………………………………………………..34
58 Protective earthing – Terminals and connections ……………………………………………………………34
59 Construction and layout ………………………………………………………………………………………………..34
Annex AA (informative) Rationale …………………………………………………………………………………………………35
Annex BB (normative) Legibility and visibility ……………………………………………………………………………….40
Annex CC (informative) Bibliography ……………………………………………………………………………………………41
Annex DD (normative) Special national conditions ………………………………………………………………………..42
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….43