16/30316718 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
Hardcopy , PDF
English
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FOREWORD
INTRODUCTION
202 Electromagnetic disturbances -
Requirements and tests
206 Usability
208 General requirements, tests and guidance
for alarm systems in medical electrical
equipment and medical electrical systems
211 Requirements for medical electrical
equipment and medical electrical systems used
in the home healthcare environment
212 General requirements, tests and guidance
for EMS 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 S[p]O[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 (normative) - Data interface requirements
Annex II (informative) - Reference to the
Essential Principles
Annex JJ (informative) - Terminology -
alphabetized index of defined terms
Bibliography
Annex ZA (informative) - Relationship between
this Document and the Essential
Requirements of EU Directive 93/42/EEC
BS EN ISO 80601-2-61.
| Committee |
CH/121/9
|
| DocumentType |
Draft
|
| Pages |
115
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
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