DIN EN ISO 9919 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
    4.101 Other test methods
    4.102 Acceptance criteria
    4.103 Pulse oximeter equipment, parts and accessories
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of equipment or equipment parts
           6.8.1 General
           6.8.2 Instructions for use
           6.8.3 Technical description
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
    10.1 Transport and storage
11 Not used
12 Not used
13 General
14 Requirements related to classification
    14.6 Types B, BF and CF equipment
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
    19.4 Tests
20 Dielectric strength
    20.4 Tests
21 Mechanical strength
    21.101 Shock and vibration
    21.102 Shock and vibration for transport
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 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
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 tests for category AP equipment, parts
    and components thereof
41 Requirements and tests for category APG equipment, parts
    and components thereof
42 Excessive temperatures
43 Fire prevention
    43.101 Pulse oximeter equipment used in conjunction
           with oxidants
           43.101.1 Ignitable material
           43.101.2 Sparking
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
    44.6 Ingress of liquids
    44.7 Cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
    49.101 Power-failure alarm condition
    49.102 Pulse oximeter equipment operation following
           interruption of the power supply
           49.102.1 Settings and data storage following short
                    interruptions or automatic switchover
           49.102.2 Operation following long interruptions
50 Accuracy of operating data
    50.101 SpO[2] accuracy of pulse oximeter equipment
           50.101.1 Specification
           50.101.2 Determination of SpO[2] accuracy
    50.102 Accuracy under conditions of motion
    50.103 Accuracy under conditions of low perfusion
    50.104 Pulse rate accuracy
51 Protection against hazardous output
    51.101 Data update period
    51.102 Detection of pulse oximeter probe and probe cable
           extender fault
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
101 Signal inadequacy
102 Pulse oximeter probes and probe cable extenders
    102.1 General
    102.2 Labelling
103 Saturation pulse information signal
104 Alarm systems
           201.1.2 Assignment of priority
           201.5.4 Default alarm preset
    201.8 Alarm signal inactivation states
           201.8.3 Indication and access
105 Appendices of IEC 60601-1:1988
Annex AA (informative) Rationale
Annex BB (informative) Skin temperature at the pulse
                       oximeter probe
Annex CC (informative) Determination of accuracy
Annex DD (informative) Calibration standards
Annex EE (informative) Guideline for evaluating and
                       documenting SpO[2] accuracy in
                       human subjects
Annex FF (informative) Simulators, calibrators and
                       functional testers for pulse
                       oximeter equipment
Annex GG (informative) Concepts of equipment response time
Annex HH (informative) Reference to the Essential Principles
Annex II (informative) Environmental aspects
Annex JJ (informative) Index of defined terms
Bibliography
Tables
Figures

Diese Allgemeinen Festlegungen spezifizieren besondere Anforderungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten.