CSA Z9919 : 2007 : R2012

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE

Publisher: Canadian Standards Association

Published:

Available Formats: PDF - English
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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

Specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans.

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Published
Document Type	Standard
Status	Superseded
Publisher	Canadian Standards Association
ProductNote	Reconfirmed EN
Pages
ISBN
Superseded By	CSA C22.2 No. 80601-2-61 : 2014(R2019)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 9919 : 2005	Identical

Standards Referencing This Book - (Show below) - (Hide below)

IEC TR 60825-9 : 1.0	SAFETY OF LASER PRODUCTS - PART 9: COMPILATION OF MAXIMUM PERMISSIBLE EXPOSURE TO INCOHERENT OPTICAL RADIATION
IEC 60825-2 : 3.2	SAFETY OF LASER PRODUCTS - PART 2: SAFETY OF OPTICAL FIBRE COMMUNICATION SYSTEMS (OFCS)
IEC 60068-2-27 : 4.0	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
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
IEC 60601-1-6 :2013 (CON ED) 3.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
IEC 60721-3-7 : 2.1	CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3-7: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - PORTABLE AND NON-STATIONARY USE
IEC 60825-1 : 3.0	SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS
ISO 14937 : 2009(R2015)	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 : 2.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL 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 : 2.0	ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
EN 563 : 94 COR 2000	SAFETY OF MACHINERY - TEMPERATURES OF TOUCHABLE SURFACES - ERGONOMICS DATA TO ESTABLISH TEMPERATURE LIMIT VALUES FOR HOT SURFACES
IEC 60601-1-2 : 4.0	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(R2015)	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 : 3.2	ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
IEC TR 60721-4-7 : 1.1	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
ASTM F 29 : 1997	SPECIFICATION FOR DUMET WIRE FOR GLASS-TO-METAL SEAL APPLICATIONS
ISO 7000 : 2014	GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS
IEC 60068-2-6 : 0	ENVIRONMENTAL TESTING - PART 2-6: TESTS - TEST FC: VIBRATION (SINUSOIDAL)
IEC 60601-1-1 : 2.0	MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
IEC 60601-1-4 : 1.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ASTM E 456 : 2013	TERMINOLOGY RELATING TO QUALITY AND STATISTICS
ISO 3534-1 : 2006(R2010)	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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