CSA C22.2 No. 80601-2-61 : 2014(R2019)
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
Hardcopy , PDF
29-07-2021
English, French
01-01-2014
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Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 ACCURACY of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
SYSTEMS
201.101 PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS
201.102 Saturation pulse INFORMATION SIGNAL
201.103 SIGNAL INPUT/OUTPUT PART
202 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements
and tests
208 Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral Standard:
General requirements, tests and guidance for
alarm systems in medical electrical equipment
and medical electrical systems
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and 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 ME EQUIPMENT
response time
Annex HH (informative) - Reference to the essential
principles of safety and performance of medical
devices in accordance with ISO/TR 16142
Bibliography
Alphabetized index of defined terms used in this standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.
| Committee |
TC 121
|
| DevelopmentNote |
Supersedes CSA Z9919. (03/2014)
|
| DocumentType |
Revision
|
| ISBN |
978-1-77139-585-4
|
| Pages |
106
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| 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 |
| IEC TR 62471-2:2009 | Photobiological safety of lamps and lamp systems - Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety |
| 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 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| 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 |
| 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 |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| 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) |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 3534-2:2006 | Statistics — Vocabulary and symbols — Part 2: Applied statistics |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| ISO 15223-1:2007 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| 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 62471:2006 | Photobiological safety of lamps and lamp systems |
| 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 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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