DIN EN ISO 9919 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
01-01-2012
12-01-2013
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.
DevelopmentNote |
Supersedes DIN EN 865 and DIN EN 865 E. (09/2005) Applies in conjunction with DIN EN 60601-1 issue 07-2007. (09/2009)
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DocumentType |
Standard
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PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
EN ISO 9919:2009 | Identical |
VDE 0750-2-54 : 2016 | Corresponds |
NEN EN ISO 9919 : 2009 | Identical |
ISO 9919:2005 | Identical |
I.S. EN ISO 9919:2009 | Identical |
NS EN ISO 9919 : 2009 | Identical |
SN EN ISO 9919 : 2009 | Identical |
UNI EN ISO 9919 : 2009 | Identical |
NF EN ISO 9919 : 2009 | Identical |
UNE-EN ISO 9919:2009 | Identical |
BS EN ISO 9919:2009 | Identical |
NBN EN ISO 9919 : 2009 | Identical |
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