Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
DIN EN ISO 10651-2:2011-06 (E)
Lung ventilators for medic al use – Particular requirements for basic safety and
essential performance – Part 2: Home care ventilators for ventilator-dependent
patients (ISO 10651-2:2004)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….5
Introduction ……………………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..8
2 Normative references ……………………………………………………………………………………………………..8
3 Terms and definitions ……………………………………………………………………………………………………..9
4 General requirements and requirements for tests ………………………………………………………….10
5 Classification ………………………………………………………………………………………………………………..11
6 Identification, marking and documents ………………………………………………………………………….11
6.1 Marking on the outside of equipment or equipment parts ………………………………………………11
6.3 Marking of controls and instruments ……………………………………………………………………………..12
6.6 Identification of medical gas cylinders and connections ………………………………………………..12
6.8.2 Instructions for use ……………………………………………………………………………………………………….13
6.8.3 Technical description ……………………………………………………………………………………………………14
6.101 Test method for legibility ………………………………………………………………………………………………15
7 Power input …………………………………………………………………………………………………………………..15
7.101 Pneumatic power …………………………………………………………………………………………………………..15
8 Basic safety categories …………………………………………………………………………………………………15
9 Removable protective means ………………………………………………………………………………………..16
10 Environmental conditions ……………………………………………………………………………………………..16
10.2.1 Environment …………………………………………………………………………………………………………………16
10.2.2 Power supply ………………………………………………………………………………………………………………..16
10.101 Pneumatic driving-power supplies …………………………………………………………………………………16
11 Not used ……………………………………………………………………………………………………………………….16
12 Not used ……………………………………………………………………………………………………………………….16
13 General …………………………………………………………………………………………………………………………16
14 Requirements related to classification …………………………………………………………………………..17
14.2 * Class II Equipment ………………………………………………………………………………………………………17
15 Limitation of voltage and/or energy ……………………………………………………………………………….17
16 Enclosures and protective covers ………………………………………………………………………………….17
17 Separation …………………………………………………………………………………………………………………….17
18 Protective earthing, functional earthing and potential equalization ……………………………….. 17
19 Continuous leakage currents and patient auxiliary currents …………………………………………. 17
19.4 * Tests …………………………………………………………………………………………………………………………. 17
20 Dielectric strength ……………………………………………………………………………………………………….. 17
21 Mechanical strength …………………………………………………………………………………………………….. 17
22 Moving parts ……………………………………………………………………………………………………………….. 18
23 Surfaces, corners and edges ……………………………………………………………………………………….. 18
24 Stability in normal use …………………………………………………………………………………………………. 18
25 Expelled parts ……………………………………………………………………………………………………………… 18
26 Vibration and noise ……………………………………………………………………………………………………… 18
27 Pneumatic and hydraulic power …………………………………………………………………………………… 18
28 Suspended masses ……………………………………………………………………………………………………… 18
29 X-radiation …………………………………………………………………………………………………………………… 18
30 Alpha, beta, gamma, neutron radiation and other particle radiation ………………………………. 18
31 Microwave radiation …………………………………………………………………………………………………….. 18
32 Light radiation (including lasers) ………………………………………………………………………………….. 18
33 Infra-red-radiation ………………………………………………………………………………………………………… 19
34 Ultraviolet radiation ……………………………………………………………………………………………………… 19
35 Acoustical energy (including ultrasonics) …………………………………………………………………….. 19
36 Electromagnetic compatibility ……………………………………………………………………………………… 19
37 Locations and basic requirements ……………………………………………………………………………….. 19
38 Marking, accompanying documents …………………………………………………………………………….. 19
39 Common requirements for category AP and category APG equipment ………………………….. 19
40 Requirements and tests for category AP equipment, parts and components thereof …….. 19
41 Requirements and tests for category APG equipment, parts and components thereof …… 19
42 Excessive temperatures ………………………………………………………………………………………………. 19
43 Fire prevention …………………………………………………………………………………………………………….. 20
43.2 * Oxygen-enriched atmospheres ………………………………………………………………………………….. 20
43.101 Compatibility with pressurized oxygen …………………………………………………………………………. 20
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility ………………………………………………………………………………………. 20
44.3 Spillage ……………………………………………………………………………………………………………………….. 20
44.7 Cleaning, sterilization and disinfection …………………………………………………………………………. 20
44.8 Compatibility with substances used with the equipment ………………………………………………. 21
45 Pressure vessels and parts subject to pressure ……………………………………………………………. 21
46 Human errors ………………………………………………………………………………………………………………..21
47 Electrostatic charges …………………………………………………………………………………………………….21
48 Biocompatibility ……………………………………………………………………………………………………………21
49 Interruption of the power supply ……………………………………………………………………………………21
49.101 *Internal electrical power source ……………………………………………………………………………………22
49.102 Additional external backup power source ………………………………………………………………………22
49.103 Spontaneous breathing during power failure …………………………………………………………………22
49.104 Accidental operation of the on/off-switch ………………………………………………………………………22
50 Accuracy of operating data ……………………………………………………………………………………………22
51 Protection against hazardous output ……………………………………………………………………………..23
51.101 Failure of air and oxygen supply systems ……………………………………………………………………..23
51.102 Adjustable ventilator breathing system pressure limitation ……………………………………………23
51.103 Maximum ventilator breathing system pressure limitation ……………………………………………..23
51.104 Measurement of airway pressure …………………………………………………………………………………..23
51.105 *High-inspiratory pressure alarm condition ……………………………………………………………………23
51.106 Expiratory monitoring ……………………………………………………………………………………………………24
51.107 Hypoventilation alarm condition ……………………………………………………………………………………25
51.108 Continuing pressure alarm condition …………………………………………………………………………….25
51.109 Respiration-rate alarm condition ……………………………………………………………………………………25
52 Abnormal operation and fault conditions ……………………………………………………………………….25
53 Environmental tests ………………………………………………………………………………………………………26
54 General …………………………………………………………………………………………………………………………26
54.3 Protection against inadvertent adjustments …………………………………………………………………..26
55 Enclosures and covers ………………………………………………………………………………………………….26
56 Components and general assembly ……………………………………………………………………………….26
56.3 Connections — General ………………………………………………………………………………………………….26
56.101 Reservoir bags and breathing tubes ………………………………………………………………………………28
56.102 Humidifiers and heat and moisture exchangers ……………………………………………………………..28
56.103 Pulse oximeters and capnometers …………………………………………………………………………………28
56.104 Oxygen monitor and alarm condition …………………………………………………………………………….28
56.105 Integrated monitoring equipment …………………………………………………………………………………..28
57 Mains parts, components and layout ……………………………………………………………………………..29
57.3 * Power supply cords …………………………………………………………………………………………………….29
58 Protective earthing — Terminals and connections ………………………………………………………….29
59 Construction and layout ………………………………………………………………………………………………..29
101 Alarm systems ………………………………………………………………………………………………………………29
201.8.3 Indication and access ……………………………………………………………………………………………………29
201.12 Alarm condition logging ………………………………………………………………………………………………..29
102 Appendices of IEC 60601-1:1988 ……………………………………………………………………………………30
Annex AA (informative) Rationale …………………………………………………………………………………………………31
Annex BB (informative) Reference to the essential principles ………………………………………………………..35
Bibliography …………………………………………………………………………………………………………………………………37
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC ……………………………………………………………………… 39