I.S. EN ISO 80601-2-85:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
Hardcopy , PDF
English
06-05-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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 for ME equipment
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 * Cerebral tissue oximeter probes and probe cable extenders
201.102 Functional connection
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 Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment
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 cerebral tissue oximeter probe
Annex CC (informative) Determination of accuracy
Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification of the accuracy of cerebral tissue oximeter equipment
Annex EE (informative) Guideline for evaluating and documenting StO2 accuracy in human subjects
Annex FF (informative) Functional testers for cerebral tissue oximeter equipment
Annex GG (informative) Concepts of ME equipment response time
Annex HH (normative) Data interface requirements
Annex II (informative) Comparison of methods of performance evaluation
Annex JJ (informative) Reference to the IMDRF essential principles and labelling guidances
Annex KK (informative) Reference to the essential principles
Annex LL (informative) Reference to the general safety and performance requirements
Annex MM (informative) Terminology — alphabetized index of defined terms
Bibliography
This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. T
| Committee |
CEN/TC 215
|
| DocumentType |
Standard
|
| Pages |
126
|
| ProductNote |
This standard is also refer as ISO 80601-2-71 The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC documen
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 80601-2-85:2021 | Identical |
| EN ISO 80601-2-85:2021 | Identical |
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