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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
Hardcopy , PDF
07-29-2021
English, French
01-01-2014
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
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