BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
Hardcopy , PDF
31-08-2011
English
31-07-2009
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
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
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
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
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
50 Accuracy of operating data
51 Protection against hazardous output
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
103 Saturation pulse information signal
104 Alarm systems
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42 EEC
Describes particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans.
| Committee |
CH/121/5
|
| DevelopmentNote |
Supersedes BS EN 865, BS 5724-2.201(1997) and 03/111613 DC. (05/2005)
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 9919:2009 | Identical |
| NEN EN ISO 9919 : 2009 | Identical |
| DIN EN ISO 9919 : 2009 | Identical |
| SN EN ISO 9919 : 2009 | Identical |
| NF EN ISO 9919 : 2009 | Identical |
| UNE-EN ISO 9919:2009 | Identical |
| ISO 9919:2005 | Identical |
| I.S. EN ISO 9919:2009 | Identical |
| NS EN ISO 9919 : 2009 | Identical |
| UNI EN ISO 9919 : 2009 | Identical |
| NBN EN ISO 9919 : 2009 | Identical |
| IEC TR 60825-9:1999 | Safety of laser products - Part 9: Compilation of maximum permissible exposure to incoherent optical radiation |
| IEC 60825-2:2004+AMD1:2006+AMD2:2010 CSV | Safety of laser products - Part 2: Safety of optical fibre communication systems (OFCS) |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| CLSI C46 A2 : 2ED 2009 | BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS |
| ISO/IEC Guide 98:1993 | Guide to the expression of uncertainty in measurement (GUM) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| CLSI C25 A : 1997 | FRACTIONAL OXYHEMAGLOBIN, OXYGEN CONTENT AND SATURATION, AND RELATED QUANTITIES IN BLOOD: TERMINOLOGY, MEASUREMENT, AND REPORTING |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| EN 563:1994/A1:1999/AC:2000 | SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| IEC TR 60721-4-7:2001+AMD1:2003 CSV | Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
| ISO 15223:2000 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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