09/30181956 DC : DRAFT MAY 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
23-11-2012
31-08-2011
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
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
Annex II (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU Directive
93/42/EEC
Bibliography
Alphabetized index of defined terms used in this standard
BS ISO 80601-2-61
| Committee |
CH/121/5
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 80601-2-61 : DRAFT 2009 | Identical |