I.S. EN 865:1997

Foreword
Introduction
Section one. General
1 Scope
2 Normative references
3 Terminology and definitions
4 General requirements and general requirements for test
5 Classification
6 Identification marking and documents
7 Power input
Section two. Environmental conditions
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
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 Separation
18 Protective earthing, functional earthing and potential
    equilization
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
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 anaesthetic 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 temperature
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 error
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
52 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
Section eleven. Additional requirements specific to pulse
oximeters
101 Pulse amplitude
Annex AA (informative) Rationale
Annex BB (informative) Guidance on pulse signals
Annex CC (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives

Covers requirements for the safety of pulse oximeters intended for use in the approximate measurement of the saturation of human arterial haemoglobin, non-invasively.