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eLibrary > BS EN ISO 80601-2-85:2021 Medical electrical equipment - Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment >

BS EN ISO 80601-2-85:2021 Medical electrical equipment - Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment, 2021

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BS EN ISO 80601-2-85:2021 Medical electrical equipment - Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment, 2021

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Contents Page
Foreword
Introduction
201.1 Scope, object and related standards [Go to Page]
201.1.1 * Scope
201.1.2 Object
201.1.3 Collateral standards
201.1.4 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements [Go to Page]
201.4.3.101 * Additional requirements for essential performance
201.4.102 Additional requirements for acceptance criteria
201.4.103 Additional requirements for cerebral tissue oximeter equipment, parts and accessories
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 [Go to Page]
201.7.1.101 Information to be supplied by the manufacturer
201.7.2.3 Consult accompanying documents
201.7.2.9.101 IP classification
201.7.2.101 Additional requirements for marking on the outside of ME equipment parts
201.7.4.3 Units of measurement
201.7.9.2 Instructions for use
201.7.9.2.1.101 Additional general requirements
201.7.9.2.2.101 Additional requirements for warnings and safety notices
201.7.9.2.9.101 Additional requirements for operating instructions
201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material
201.7.9.3.1.101 * Additional general requirements
201.8 Protection against electrical hazards from ME equipment [Go to Page]
201.8.3.101 Additional requirements for classification of applied parts
201.8.5.5.1.101 Defibrillation protection
201.8.7.4.7.101 Additional requirements for measurement of the patient leakage current
201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards [Go to Page]
201.10.4 Lasers
201.11 Protection against excessive temperatures and other hazards [Go to Page]
201.11.1.2.2 Applied parts not intended to supply heat to a patient
201.11.6.5.101 * Additional requirements for ingress of water or particulate matter into the ME equipment or ME system
201.11.6.7 Sterilization of ME equipment or ME system
201.11.8.101 Additional requirements for interruption of the power supply/supply mains to ME equipment
201.11.8.101.1 Technical alarm condition for power supply failure
201.11.8.101.2 Settings and data storage following short interruptions or automatic switchover
201.11.8.101.3 Operation following long interruptions
201.12 Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
201.12.1.101 * StO2 accuracy of cerebral tissue oximeter equipment
201.12.1.101.1 * Specification
201.12.1.101.2 * Data collection for determination of StO2 accuracy
201.12.1.101.3 * Data analysis for determination of StO2 accuracy
201.12.1.101.4 Characteristics of the study used for determination of StO2 accuracy
201.12.4 Protection against hazardous output
201.12.4.101 * Data update period
201.12.4.102 * Signal inadequacy
201.13 Hazardous situations and fault conditions for ME equipment [Go to Page]
201.13.101 Detection of probe faults and probe cable extender faults
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment [Go to Page]
201.15.3.5.101 * Additional requirements for rough handling
201.15.3.5.101.1 * Shock and vibration (robustness)
201.15.3.5.101.2 * Shock and vibration for a transit-operable cerebral tissue oximeter during operation
201.15.101 Mode of operation
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
201.101 * Cerebral tissue oximeter probes and probe cable extenders [Go to Page]
201.101.1 General
201.101.2 Labelling
201.102 Functional connection [Go to Page]
201.102.1 General
201.102.2 * Connection to an electronic health record or integrated clinical environment
201.102.3 Connection to a distributed alarm system
202 Electromagnetic disturbances — Requirements and tests [Go to Page]
202.4.3.1 Configurations
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems
202.8.1.101 Additional general requirements
202.8.2 Patient physiological simulation
206 Usability
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Go to Page]
208.6.1.2.101 * Additional requirements for alarm condition priority
208.6.5.4.101 * Additional requirements for default alarm preset
208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and access
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 [Go to Page]
201.C.1 Marking on the outside of ME equipment, ME systems or their parts
201.C.2 Accompanying documents, general
201.C.3 Accompanying documents, instructions for use
201.C.4 Accompanying documents, technical description
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale [Go to Page]
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses
Annex BB (informative) Skin temperature at the cerebral tissue oximeter probe [Go to Page]
BB.1 Surface temperature limits
BB.2 Literature review
BB.3 Test methods
Annex CC (informative) Determination of accuracy [Go to Page]
CC.1 General
CC.2 Accuracy, bias and precision [Go to Page]
CC.2.1 Definitions from other standards [Go to Page]
CC.2.1.1 Accuracy
CC.2.1.2 Bias
CC.2.1.3 Precision
CC.2.2 Effects of offset and linearity errors
CC.2.3 Bias (see Figures CC.1 and CC.2)
CC.2.4 Precision
CC.2.5 Accuracy
CC.2.6 Analysis
CC.2.7 Trend accuracy
CC.2.8 Statistical Considerations
Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification of the accuracy of cerebral tissue oximeter equipment [Go to Page]
DD.1 General
DD.2 Features of the tissue haemoglobin phantom [Go to Page]
DD.2.1 General
DD.2.2 Safety precautions regarding blood or blood components
DD.2.3 Composition of the tissue haemoglobin phantom liquid
DD.2.4 Design of the tissue haemoglobin phantom setup [Go to Page]
DD.2.4.1 Liquid-probe interface
DD.2.4.2 Container
DD.2.4.3 Probe arrangement [Go to Page]
DD.2.4.3.1 Immersed probe
DD.2.4.3.2 Probe attached to turbid window
DD.2.5 Methods to change oxygenation
DD.2.6 Reference measurement for SphanO2
DD.3 Procedures for verification of cerebral tissue oximeter equipment with the tissue haemoglobin phantom [Go to Page]
DD.3.1 Purpose of the verification
DD.3.2 Test procedure of the verification
DD.4 Specifications of the tissue haemoglobin phantom
DD.4.1 Target parameters of the tissue haemoglobin phantom
DD.4.2 Properties of the tissue haemoglobin phantom to be disclosed
Annex EE (informative) Guideline for evaluating and documenting StO2 accuracy in human subjects [Go to Page]
EE.1 General
EE.2 Procedure for laboratory testing on healthy volunteers [Go to Page]
EE.2.1 Purpose of a controlled desaturation study
EE.2.2 Scope of a controlled desaturation study
EE.2.3 Methods
EE.2.3.1 Study population
EE.2.3.2 Apparatus [Go to Page]
EE.2.3.2.1 CO-oximeter for measuring SaO2, SjvO2 and procedures and supplies recommended by the CO-oximeter manufacturer.
EE.2.3.2.2 Materials for arterial catheterization, jugular venous bulb catheter and blood sampling.
EE.2.3.2.3 Means for recording StO2 values (device under test), which can be manual or automated.
EE.2.3.2.4 Cerebral tissue oximeter equipment to be tested. See also EE.2.3.4 c).
EE.2.3.2.5 Means for delivering a medical grade oxygen-nitrogen mixture of varying FiO2 levels to the subject (e.g. pre-mixed high-pressure cylinders or gas-mixing equipment).
EE.2.3.3 Procedure
EE.2.3.4 Data analysis
EE.3 Testing on patients [Go to Page]
EE.3.1 Procedure
Annex FF (informative) Functional testers for cerebral tissue oximeter equipment [Go to Page]
FF.1 General
FF.2 What is a simulator?
FF.3 What is a functional tester?
FF.4 Types of functional testers and their uses
Annex GG (informative) Concepts of ME equipment response time [Go to Page]
GG.1 General
GG.2 Fidelity
GG.3 Effects of delays
Annex HH (normative) Data interface requirements [Go to Page]
HH.1 Background and purpose
HH.2 Data definition
HH.3 Clinical context
Annex II (informative) Comparison of methods of performance evaluation [Go to Page]
II.1 General
II.2 Rationale for multiple methods of accuracy performance verification
II.3 Desire for improvement of methods for accuracy performance verification
II.4 Optimizing the methods of accuracy performance verification
II.5 Comparing the methods of accuracy performance verification
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 [Go to Page]

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