BS EN ISO 80601-2-61:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment
Hardcopy , PDF
English
31-08-2011
14-03-2019
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative reference
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 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 (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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT.
| Committee |
CH/121/5
|
| DevelopmentNote |
Supersedes BS EN ISO 9919 and 09/30181956 DC. (08/2011)
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-61:2011 | Identical |
| EN ISO 80601-2-61:2011 | Identical |
| I.S. EN ISO 80601-2-61:2011 | Equivalent |
| ISO 80601-2-61:2011 | Equivalent |
| UNE-EN ISO 80601-2-61:2011 | Equivalent |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.