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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
- undefined
- 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]
