Medical Electrical Equipment - Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment
Japanese Standards Association
Introduction
Section 1: General
1 Scope and object
1A Normative references
2 Terms and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
Section 2: Environmental conditions
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
Section 3: 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 4: 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 5: 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 Infrared radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
Section 6: Protection against hazards of ignition
of flammable anaesthetic agent
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 7: 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 8: Accuracy of operating data and protection
against hazardous output
50 Accuracy of operating data
50.3 Flow indicator
50.4 Oxygen concentration
50.5 Mean oxygen concentration
50.6 Tolerance on flowrate
50.7 Backpressure effect
50.8 Outlet pressure
51 Protection against hazardous output
51.1 Flow control device
51.2 Filter
51.5 Oxygen concentration status indicator
Section 9: Abnormal operation and fault conditions;
environmental tests
52 Abnormal operation and fault conditions
53 Environmental tests
Section 10: 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
Section 11: Additional clauses
60 Auditory indicators
61 Indication of loss of mains power
Annex N (normative) - Test apparatus
Annex P (informative) - Rationale statement
Annex Q (informative) - Bibliography
Annex JA (informative) - Comparison table between JIS
and corresponding International Standard
Describes safety requirements for continuous-flow oxygen concentrators.
| Document Type | Standard |
| Status | Current |
| Publisher | Japanese Standards Association |
| Supersedes |
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