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INTERNATIONAL ISO
STANDARD 80601-2-85
First edition
2021-03
Medical electrical equipment —
Part 2-85:
Particular requirements for the basic
safety and essential performance of
cerebral tissue oximeter equipment
Appareils électromédicaux —
Partie 2-85: Exigences particulières pour la sécurité de base et les
performances essentielles des oxymètres pour tissu cérébral
Reference number
©
ISO 2021
© ISO 2021
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Published in Switzerland
ii © ISO 2021 – All rights reserved
Contents Page
Foreword . vi
Introduction . vii
201.1 Scope, object and related standards . 1
201.1.1 * Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 3
201.2 Normative references . 4
201.3 Terms and definitions . 5
201.4 General requirements . 10
201.4.3.101 * Additional requirements for essential performance . 11
201.4.102 Additional requirements for acceptance criteria . 11
201.4.103 Additional requirements for cerebral tissue oximeter equipment, parts and
accessories . 11
201.5 General requirements for testing of ME equipment . 12
201.6 Classification of ME equipment and ME systems . 12
201.7 ME equipment identification, marking and documents . 12
201.7.1.101 Information to be supplied by the manufacturer . 12
201.7.2.3 Consult accompanying documents . 12
201.7.2.9.101 IP classification . 12
201.7.2.101 Additional requirements for marking on the outside of ME equipment parts . 13
201.7.4.3 Units of measurement . 13
201.7.9.2 Instructions for use . 13
201.7.9.2.1.101 Additional general requirements. 13
201.7.9.2.2.101 Additional requirements for warnings and safety notices . 15
201.7.9.2.9.101 Additional requirements for operating instructions . 15
201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used
material . 15
1.7.9.3.1.101 * Additional general requirements . 16
201.8 Protection against electrical hazards from ME equipment . 16
201.8.3.101 Additional requirements for classification of applied parts . 16
201.8.5.5.1.101 Defibrillation protection . 16
201.8.7.4.7.101 Additional requirements for measurement of the patient leakage current . 16
201.9 Protection against mechanical hazards of ME equipment and ME systems . 17
201.10 Protection against unwanted and excessive radiation hazards . 17
201.10.4 Lasers . 17
201.11 Protection against excessive temperatures and other hazards . 17
201.11.1.2.2 Applied parts not intended to supply heat to a patient . 17
201.11.6.5.101 * Additional requirements for ingress of water or particulate matter into
the ME equipment or ME system. 18
201.11.6.7 Sterilization of ME equipment or ME system . 18
201.11.8.101 Additional requirements for interruption of the power supply/supply mains
to ME equipment . 18
201.11.8.101.1 Technical alarm condition for power supply failure . 18
201.11.8.101.2 Settings and data storage following short interruptions or automatic
switchover . 19
201.11.8.101.3 Operation following long interruptions . 19
201.12 Accuracy of controls and instruments and protection against hazardous outputs. 19
201.12.1.101 * StO accuracy of cerebral tissue oximeter equipment . 19
201.12.1.101.1 * Specification . 19
201.12.1.101.2 * Data collection for determination of StO accuracy . 21
201.12.1.101.3 * Data analysis for determination of StO accuracy . 22
201.12.1.101.4 Characteristics of the study used for determination of StO accuracy . 23
201.12.4 Protection against hazardous output . 23
201.12.4.101 * Data update period . 23
201.12.4.102 * Signal inadequacy . 23
201.13 Hazardous situations and fault conditions for ME equipment . 24
201.13.101 Detection of probe faults and probe cable extender faults . 24
201.14 Programmable electrical medical systems (PEMS) . 24
201.15 Construction of ME equipment . 24
201.15.3.5.101 * Additional requirements for rough handling . 25
201.15.3.5.101.1 * Shock and vibration (robustness) . 25
201.15.3.5.101.2 * Shock and vibration for a transit-operable cerebral tissue oximeter
during operation . 26
201.15.101 Mode of operation. 27
201.16 ME systems. 27
201.17 Electromagnetic compatibility of ME equipment and ME systems. 27
201.101 * Cerebral tissue oximeter probes and probe cable extenders . 27
201.101.1 General . 27
201.101.2 Labelling . 28
201.102 Functional connection . 28
201.102.1 General . 28
201.102.2 * Connection to an electronic health record or integrated clinical environment . 28
201.102.3 Connection to a distributed alarm system . 28
202 Electromagnetic disturbances — Requirements and tests . 29
202.4.3.1 Configurations . 29
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 29
202.8.1.101 Additional general requirements . 29
202.8.2 Patient physiological simulation . 29
206 Usability . 30
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems. 30
208.6.1.2.101 * Additional requirements for alarm condition priority . 30
208.6.5.4.101 * Additional requirements for default alarm preset . 31
208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and
access . 31
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 31
212 Requirements for medical electrical equipment and medical electrical systems used
in the emergency medical services environment . 31
iv © ISO 2021 – All rights reserved
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 32
Annex D (informative) Symbols on marking. 36
Annex AA (informative) Particular guidance and rationale . 37
Annex BB (informative) Skin temperature at the cerebral tissue oximeter probe . 48
Annex CC (informative) Determination of accuracy . 50
Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification
of the accuracy of cerebral tissue oximeter equipment . 56
Annex EE (info
...