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BS EN ISO 80601-2-85:2021

BS EN ISO 80601-2-85:2021

$215.11

Medical electrical equipment – Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

Published By Publication Date Number of Pages
BSI 2021 118
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Clause 1 of the general standard applies, except as follows.

NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Contents Page
8 Foreword
9 Introduction
11 201.1 Scope, object and related standards
201.1.1 * Scope
12 201.1.2 Object
201.1.3 Collateral standards
13 201.1.4 Particular standards
14 201.2 Normative references
15 201.3 Terms and definitions
20 201.4 General requirements
21 201.4.3.101 * 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
22 201.5 General requirements for testing of ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents
201.7.1.101 Information to be supplied by the manufacturer
201.7.2.3 Consult accompanying documents
201.7.2.9.101 IP classification
23 201.7.2.101 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
25 201.7.9.2.2.101 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
26 201.7.9.3.1.101 * Additional general requirements
201.8 Protection against electrical hazards from ME equipment
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
27 201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards
201.10.4 Lasers
201.11 Protection against excessive temperatures and other hazards
201.11.1.2.2 Applied parts not intended to supply heat to a patient
28 201.11.6.5.101 * 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
29 201.11.8.101.2 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
201.12.1.101 * StO2 accuracy of cerebral tissue oximeter equipment
201.12.1.101.1 * Specification
31 201.12.1.101.2 * Data collection for determination of StO2 accuracy
32 201.12.1.101.3 * Data analysis for determination of StO2 accuracy
33 201.12.1.101.4 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
34 201.13 Hazardous situations and fault conditions for ME equipment
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
35 201.15.3.5.101 * Additional requirements for rough handling
201.15.3.5.101.1 * Shock and vibration (robustness)
36 201.15.3.5.101.2 * Shock and vibration for a transit-operable cerebral tissue oximeter during operation
37 201.15.101 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
201.101.1 General
38 201.101.2 Labelling
201.102 Functional connection
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
39 202 Electromagnetic disturbances — Requirements and tests
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
40 206 Usability
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2.101 * Additional requirements for alarm condition priority
41 208.6.5.4.101 * 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
42 Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
201.C.1 Marking on the outside of ME equipment, ME systems or their parts
201.C.2 Accompanying documents, general
43 201.C.3 Accompanying documents, instructions for use
45 201.C.4 Accompanying documents, technical description
46 Annex D (informative) Symbols on marking
47 Annex AA (informative) Particular guidance and rationale
AA.1 General guidance
49 AA.2 Rationale for particular clauses and subclauses
58 Annex BB (informative) Skin temperature at the cerebral tissue oximeter probe
BB.1 Surface temperature limits
BB.2 Literature review
BB.3 Test methods
60 Annex CC (informative) Determination of accuracy
CC.1 General
CC.2 Accuracy, bias and precision
CC.2.1 Definitions from other standards
CC.2.1.1 Accuracy
CC.2.1.2 Bias
61 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)
63 CC.2.4 Precision
CC.2.5 Accuracy
64 CC.2.6 Analysis
65 CC.2.7 Trend accuracy
CC.2.8 Statistical Considerations
66 Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification of the accuracy of cerebral tissue oximeter equipment
DD.1 General
67 DD.2 Features of the tissue haemoglobin phantom
DD.2.1 General
68 DD.2.2 Safety precautions regarding blood or blood components
DD.2.3 Composition of the tissue haemoglobin phantom liquid
69 DD.2.4 Design of the tissue haemoglobin phantom setup
DD.2.4.1 Liquid-probe interface
DD.2.4.2 Container
70 DD.2.4.3 Probe arrangement
DD.2.4.3.1 Immersed probe
DD.2.4.3.2 Probe attached to turbid window
71 DD.2.5 Methods to change oxygenation
72 DD.2.6 Reference measurement for SphanO2
73 DD.3 Procedures for verification of cerebral tissue oximeter equipment with the tissue haemoglobin phantom
DD.3.1 Purpose of the verification
DD.3.2 Test procedure of the verification
74 DD.4 Specifications of the tissue haemoglobin phantom
DD.4.1 Target parameters of the tissue haemoglobin phantom
75 DD.4.2 Properties of the tissue haemoglobin phantom to be disclosed
76 Annex EE (informative) Guideline for evaluating and documenting StO2 accuracy in human subjects
EE.1 General
EE.2 Procedure for laboratory testing on healthy volunteers
EE.2.1 Purpose of a controlled desaturation study
EE.2.2 Scope of a controlled desaturation study
77 EE.2.3 Methods
EE.2.3.1 Study population
78 EE.2.3.2 Apparatus
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
80 EE.2.3.4 Data analysis
EE.3 Testing on patients
EE.3.1 Procedure
82 Annex FF (informative) Functional testers for cerebral tissue oximeter equipment
FF.1 General
FF.2 What is a simulator?
FF.3 What is a functional tester?
83 FF.4 Types of functional testers and their uses
85 Annex GG (informative) Concepts of ME equipment response time
GG.1 General
GG.2 Fidelity
87 GG.3 Effects of delays
90 Annex HH (normative) Data interface requirements
HH.1 Background and purpose
HH.2 Data definition
93 HH.3 Clinical context
94 Annex II (informative) Comparison of methods of performance evaluation
II.1 General
II.2 Rationale for multiple methods of accuracy performance verification
II.3 Desire for improvement of methods for accuracy performance verification
95 II.4 Optimizing the methods of accuracy performance verification
II.5 Comparing the methods of accuracy performance verification
99 Annex JJ (informative) Reference to the IMDRF essential principles and labelling guidances
102 Annex KK (informative) Reference to the essential principles
105 Annex LL (informative) Reference to the general safety and performance requirements
108 Annex MM (informative) Terminology — alphabetized index of defined terms
112 Bibliography

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