EN ISO 80601-2-85:2021
(Main)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)
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)
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. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.
Not included within the scope of this document are:
invasive tissue or vascular oximeters;
oximeters that require a blood sample from the patient;
equipment measuring dissolved oxygen;
ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4];
ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61[3];
ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.
This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
Medizinische elektrische Geräte - Teil 2-85: Besondere Anforderungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die zerebrale Oxymetrie (ISO 80601-2-85:2021)
Dieses Dokument ist anzuwenden für die Basissicherheit und wesentlichen Leistungsmerkmale von zerebralen Gewebeoximetriegeräten, die Licht verschiedener Wellenlänge zur quantitativen Messung der Sauerstoffsättigung des Hämoglobins innerhalb des unter dem am Kopf befestigten Sensor befindlichen Gewebevolumens nutzen. Die Technologie des zerebralen Gewebeoximetriegeräts kann auf Dauerlicht, dem Frequenzbereich oder dem Zeitbereich basieren. Dieses Dokument ist anzuwenden für in einer Klinikumgebung verwendete ME Geräte, sowie wenn diese außerhalb der Klinikumgebung z. B. in Rettungsdienstfahrzeugen oder beim Lufttransport verwendet werden. Weitere Normen für diese Einsatzbedingungen können auf ME Geräte anwendbar sein.
ANMERKUNG 1 Zerebrale Gewebeoximetriegeräte werden in der medizinischen Literatur manchmal auch als Nahinfrarotspektroskopiegeräte bezeichnet.
Nicht im Anwendungsbereich dieses Dokuments enthalten sind:
- invasive Gewebe oder Gefäßoximeter;
- Oximeter, die eine Blutprobe des Patienten erfordern;
- Geräte zur Messung von Gelöstsauerstoff;
- ME Geräte, oder Teile davon, die weglängenabhängige Hämoglobinänderungen messen. Die Anforderungen an funktionelle Nahinfrarotspektroskopiegeräte sind in ISO 80601-2-71 [4] zu finden;
- ME Geräte, oder Teile davon, die die arterielle Sättigung anhand pulsatiler Änderungen der optischen Eigenschaften des Gewebes (SpO2) messen. Die Anforderungen an Pulsoximetriegeräte sind in ISO 80601-2-61 [3] zu finden;
- ME Geräte, oder jegliche Teile davon, die den Anspruch erheben, Gewebe in anderen Körperteilen als dem Kopf zu überwachen.
Dieses Dokument ist auch anzuwenden für zerebrale Gewebeoximetriegeräte, einschließlich zerebraler Gewebeoximetriemonitore, zerebraler Gewebeoximetriesensoren und Sensorverlängerungskabel, die wiederaufbereitet wurden.
Wenn ein Abschnitt oder Unterabschnitt speziell nur auf ME Geräte oder ME Systeme angewendet werden soll, wird dies aus der Überschrift und dem Inhalt des jeweiligen Abschnitts oder Unterabschnitts deutlich. In den übrigen Fällen gilt der Abschnitt oder Unterabschnitt je nach Zutreffen für sowohl ME Geräte als auch ME Systeme.
Gefährdungen, die sich aus der vorgesehenen physiologischen Funktion von ME Geräten oder ME Systemen im Anwendungsbereich dieses Dokuments ergeben, sind nicht durch besondere Anforderungen in diesem Dokument erfasst, ausgenommen in 201.11 und in 201.7.2.13 und 201.8.4.1 der allgemeinen Norm.
ANMERKUNG 2 Siehe auch 4.2 der allgemeinen Norm.
Dieses Dokument kann auch auf ME Geräte und deren Zubehör angewendet werden, die für die Kompensation oder Linderung bei Krankheiten, Verletzungen oder Behinderungen verwendet werden.
Dieses Dokument ist nicht anzuwenden für entfernt aufgestellte oder gekoppelte (sekundäre) Geräte, die StO2 Werte anzeigen und die sich außerhalb der Patientenumgebung befinden.
ANMERKUNG 3 Von ME Geräten, bei denen die Auswahl zwischen einer Diagnose und einer Überwachungsfunktion möglich ist, wird erwartet, dass sie die Anforderungen des entsprechenden Dokuments erfüllen, wenn sie für die jeweilige Funktion konfiguriert sind.
Appareils électromédicaux - Partie 2-85: Exigences particulières pour la sécurité de base et les performances essentielles des oxymètres pour tissu cérébral (ISO 80601-2-85:2021)
Le présent document s'applique à la sécurité de base et aux performances essentielles des oxymètres pour tissu cérébral, qui utilisent la lumière à plusieurs longueurs d'onde afin d'obtenir une mesure quantitative de la saturation en oxygène de l'hémoglobine dans le volume de tissu échantillonné sous le capteur fixé à la tête. L'oxymètre pour tissu cérébral peut s'appuyer sur des technologies de lumière continue, de domaine fréquentiel ou de domaine temporel. Le présent document s'applique aux appareils EM utilisés en environnement hospitalier ou en dehors de l'environnement hospitalier, par exemple dans des ambulances ou lors d'un transport aérien. D'autres normes peuvent s'appliquer aux appareils EM pour ces environnements d'utilisation.
NOTE 1 Les oxymètres pour tissu cérébral sont parfois appelés « appareils de spectroscopie dans le proche infrarouge » ou « appareils NIRS » (near infrared spectroscopy) dans la littérature médicale.
Les éléments suivants ne relèvent pas du domaine d'application du présent document :
les oxymètres tissulaires ou vasculaires invasifs ;
les oxymètres nécessitant un échantillon sanguin du patient ;
les appareils de mesure de l'oxygène dissous ;
les appareils EM, ou parties de ceux-ci, qui mesurent le changement de l'hémoglobine en fonction de la longueur du trajet. Les exigences relatives aux appareils de spectroscopie dans le proche infrarouge figurent dans l'ISO 80601-2-71 [4] ;
les appareils EM, ou parties de ceux-ci, qui mesurent la saturation artérielle en fonction des changements pulsatiles dans les propriétés optiques des tissus (SpO2). Les exigences relatives aux oxymètres de pouls figurent dans l'ISO 80601-2-61 [3] ;
les appareils EM, ou parties de ceux-ci, qui revendiquent la surveillance des tissus dans des parties du corps autres que la tête.
Le présent document s'applique également aux oxymètres pour tissu cérébral, y compris les moniteurs d'oxymètres pour tissu cérébral, les capteurs d'oxymètres pour tissu cérébral et les câbles de raccordement du capteur, qui ont fait l'objet d'une remise à neuf.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11, 201.7.2.13 et 201.8.4.1 de la norme générale.
NOTE 2 Voir également 4.2 de la norme générale.
Le présent document peut également être appliqué aux appareils EM et leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité.
Le présent document ne s'applique pas aux appareils à distance ou esclaves (secondaires) qui affichent les valeurs de StO2 et qui sont situés en dehors de l'environnement du patient.
NOTE 3 Il est attendu que les appareils EM qui offrent le choix entre des fonctions de diagnostic et de surveillance respectent les exigences du document approprié lorsqu'ils sont configurés pour cette fonction.
Medicinska električna oprema - 2-85. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za cerebralno oksimetrijo (ISO 80601-2-85:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2021
Medicinska električna oprema - 2-85. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za cerebralno oksimetrijo (ISO 80601-2-85:2021)
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)
Medizinische elektrische Geräte - Teil 2-85: Besondere Anforderungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten für die nicht-invasive
zerebrale Oxymetrie (ISO 80601-2-85:2021)
Appareils électromédicaux - Partie 2-85: Exigences particulières pour la sécurité de base
et les performances essentielles des oxymètres pour tissu cérébral (ISO 80601-2-
85:2021)
Ta slovenski standard je istoveten z: EN ISO 80601-2-85:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-85
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
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)
Appareils électromédicaux - Partie 2-85: Exigences Medizinische elektrische Geräte - Teil 2-85: Besondere
particulières pour la sécurité de base et les Anforderungen für die Sicherheit einschließlich der
performances essentielles des oxymètres pour tissu wesentlichen Leistungsmerkmale von Geräten für die
cérébral (ISO 80601-2-85:2021) nicht-invasive zerebrale Oxymetrie (ISO 80601-2-
85:2021)
This European Standard was approved by CEN on 21 January 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-85:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-85:2021) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2021, and conflicting national standards shall
be withdrawn at the latest by April 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-85:2021 has been approved by CEN as EN ISO 80601-2-85:2021 without any
modification.
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 80601-2-85:2021(E)
©
ISO 2021
ISO 80601-2-85:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 80601-2-85:2021(E)
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
201.7.9.3.1.101 * 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
ISO 80601-2-85:2021(E)
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
ISO 80601-2-85:2021(E)
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 (informative) Guideline for evaluating and documenting StO accuracy in human
subjects . 66
Annex FF (informative) Functional testers for cerebral tissue oximeter equipment . 72
Annex GG (informative) Concepts of ME equipment response time . 75
Annex HH (normative) Data interface requirements . 80
Annex II (informative) Comparison of methods of performance evaluation . 84
Annex JJ (informative) Reference to the IMDRF essential principles and labelling guidances . 89
Annex KK (informative) Reference to the essential principles . 92
Annex LL (informative) Reference to the general safety and performance requirements . 95
Annex MM (informative) Terminology — alphabetized index of defined terms . 98
Bibliography . 102
ISO 80601-2-85:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee 62D,
Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vi © ISO 2021 – All rights reserved
ISO 80601-2-85:2021(E)
Introduction
The estimation of blood oxygen saturation in the brain tissue by cerebral tissue oximetry equipment is
increasingly used in many areas of medicine. This document covers basic safety and essential
performance requirements achievable within the limits of existing technology.
Annex AA contains a rationale for some of the requirements. It is included to provide additional insight
into the reasoning of the committees that led to a requirement and into the hazards that the
requirement addresses.
Annex BB is a literature review and provides recommendations relevant to determining the maximum
safe temperature of the interface between a cerebral tissue oximeter probe and a patient's tissue.
Annex CC discusses both the formulae used to evaluate the StO accuracy of cerebral tissue oximeter
equipment measurements, and the names that are assigned to those formulae.
Annex DD presents guidance on using in-vitro methods (phantoms) for verification of StO accuracy of
cerebral tissue oximeter equipment.
Annex EE presents a guideline for an in-vivo (human subjects) controlled desaturation study for the
verification of StO accuracy of cerebral tissue oximeter equipment.
Annex FF is a description of functional testers for use with cerebral tissue oximeter equipment.
Annex GG describes concepts of cerebral tissue oximeter equipment response time.
Annex HH describes data interface requirements.
Annex II is a comparison between human desaturations (in-vivo) and tissue haemoglobin phantom
desaturations (in-vitro) for assessing StO accuracy.
In this document, the following print types are used:
— requirements and definitions: roman type;
— Instructions, test specifications and terms defined in Clause 3 of the general standard, in this document
or as noted: italic type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type; normative text of tables is also in a smaller type.
In referring to the structure of this document, the term
— “clause” means one of the numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201.7 includes subclauses 201.7.1, 201.7.2) and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this document are by number only.
ISO 80601-2-85:2021(E)
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— “should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document; and
— “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test);
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in AA.
viii © ISO 2021 – All rights reserved
INTERNATIONAL STANDARD ISO 80601-2-85:2021(E)
Medical electrical equipment —
Part 2-85:
Particular requirements for the basic safety and essential
performance of cerebral tissue oximeter equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 * Scope
Replacement:
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. The cerebral
tissue oximeter equipment can be based on continuous light, frequency domain or time domain
technologies. This document applies to ME equipment used in a hospital environment as well as when
used outside the hospital environment, such as in ambulances and air transport. Additional standards
may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical
literature.
Not included within the scope of this document are:
invasive tissue or vascular oximeters;
oximeters that require a blood sample from the patient;
equipment measuring dissolved oxygen;
ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The
[4]
requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71 ;
ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in
tissue optical properties (SpO ). The requirements for pulse oximeter equipment are found in
[3]
ISO 80601-2-61 ;
ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the
head.
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter
monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.
ISO 80601-2-85:2021(E)
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except in 201.11 and
in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document can also be applied to ME equipment and their accessories used for compensation or
alleviation of disease, injury or disability.
This document is not applicable to remote or slave (secondary) equipment that displays StO values
that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet
the requirements of the appropriate document when configured for that function.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance
requirements for cerebral tissue oximeter equipment [as defined in 201.3.202] and its accessories.
NOTE 1 Accessories are included because the combination of the cerebral tissue oximeter monitor and the
accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential
performance of cerebral tissue oximeter equipment.
NOTE 2 This document has been prepared to address the relevant International Medical Device Regulators Forum
(IMDRF) essential principles and labelling guidances as indicated in Annex JJ.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of
ISO 16142-1:2016 as indicated in Annex KK.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of
[20]
European regulation (EU) 2017/745 as indicated in Annex LL.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and Clause 201.2 of this document.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11:2015+AMD1:2020 and
IEC 60601-1-12:2014+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212
respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1
series apply as published.
2 © ISO 2021 – All rights reserved
ISO 80601-2-85:2021(E)
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards define basic safety and essential performance
requirements, and may modify, replace or delete requirements contained in the general standard,
including the collateral standards, as appropriate for the particular ME equipment under consideration.
A requirement of a particular standard takes priority over the general standard or the collateral
standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of
the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4
of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of the general
standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Clauses, subclauses or figures that are additional to those of the general standard are numbered starting
from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1
through 3.147, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
2xx, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-
3, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this particular document, the section, clause or
subclause of the general standard or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of the general standard or applicable
collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in
this particular document.
ISO 80601-2-85:2021(E)
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
Clause 2 of the general standard applies, except as follows:
Replacement:
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
Addition:
ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of
medical devices — Part 1: General essential principles and additional specific essential principles for all
non-IVD medical devices and guidance on the selection of standards
ISO 17664:2017, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 20417:2020, Medical devices — Information to be supplied by the manufacturer
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
primarily for equipment-type specimens
IEC 60068-2-64:2008+AMD1:2019, Environmental testing — Part 2-64: Tests — Test Fh: Vibration,
broadband random and guidance
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment — Part 1-11: General requirements for
basic safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-12:2014+AMD1:2020, Medical electrical equipment — Part 1-12: General requirements for
basic safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical services environment
ISO 80601-2-61:2017, Medical electrical equipment — Part 2-61: Particular requirements for basic safety
and essential performance of pulse oximeter equipment
IEC 62471:2006, Photobiological safety of lamps and lamp systems
Under preparation. Stage at the time of publication: ISO/DIS 15223-1:2020.
4 © ISO 2021 – All rights reserved
ISO 80601-2-85:2021(E)
AAMI 2700-1:2019 , Medical devices and medical systems — Essential safety requirements for equipment
comprising the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and
conceptual model
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 16142-1:2016,
ISO 17664:2017, ISO 20417:2020, IEC 60601-1:2005+AMD1:2012+AMD2:2020,
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11:2015+AMD1:2020,
IEC 60601-1-12:2014+AMD2:2020, ISO 80601-2-61:2017, AAMI 2700-1:2019 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
NOTE An alphabetized index of defined terms is found in Annex MM.
201.3.201
accuracy
A
rms
closeness of agreement between a test result and the true value
Note 1 to entry: 201.12.1.101.2 contains methods for estimating the StO accuracy of cerebral tissue oximeter
equipment.
Note 2 to entry: Additional information is found in Annexes CC, DD, EE and II.
Note 3 to entry: In this document, accuracy (A ) is stated in terms of the root mean square difference. See
rms
201.12.1.101.3.
[6]
[SOURCE: ISO 3534-2:2006 3.3.1, modified — Notes to entry replaced.]
201.3.202
cerebral tissue oximeter
cerebral tissue oximeter equipment
ME equipment for the non-invasive estimation of functional oxygen saturation of haemoglobin in
cerebral tissue below the probe (StO or rSO ), based on light interacting with tissue
2 2
Note 1 to entry: Cerebral tissue oximeter equipment comprises a cerebral tissue oximeter monitor, a probe cable
extender, if provided, and a cerebral tissue oximeter probe, which can be combined in a single assembly.
Note 2 to entry: Light is more technically referred to as electromagnetic radiation (optical radiation). This
document uses the common term.
Note 3 to entry: Measurements are based upon light interacting with all tissue under the probe to determine StO2.
201.3.203
cerebral tissue oximeter monitor
monitor
part of the cerebral tissue oximeter equipment that encompasses the measurement electronics, display
and operator interface, excluding the cerebral tissue oximeter probe and probe cable extender
Formerly ASTM F2761-09.
ISO 80601-2-85:2021(E)
Note 1 to entry: A cerebral tissue oximeter monitor can consist of multiple pieces of hardware in separate locations,
e.g. a telemetry system in which the applied part and primary display are physically separated.
201.3.204
cerebral tissue oximeter probe
probe
part of the cerebral tissue oximeter equipment that includes the applied part
Note 1 to entry: The terms sensor and transducer have also been used for cerebral tissue oximeter probe.
Note 2 to entry: A reflectance probe design is the typical configuration.
201.3.205
controlled desaturation study
hypoxaemia induced in a group of human subjects performed under laboratory conditions
Note 1 to entry: This can also be referred to as a controlled hypoxaemia study. Additional information is found in
Annex EE.
[3]
[SOURCE: ISO 80601-2-61:2017 , 201.3.202]
201.3.206
CO-oximeter
multiwavelength, optical analyser that measures total haemoglobin concentration and the
concentrations of various haemoglobin derivatives via direct measurement of a blood specimen
Note 1 to entry: The relevant CO-oximetry values for this document are functional oxygen saturation of arterial
and jugular venous blood, SaO and SjvO .
Note 2 to entry: This excludes indirect measurements that are performed by pulse oximetry and other optical
measurements methods on human tissue.
[7]
[SOURCE: CLSI C46-A2: 2009, 4.1.9 ]
201.3.207
data update period
interval in which the cerebral tissue oximeter equipment algorithm provides new valid data to the
display or the functional connection
Note 1 to entry: This definition does not refer to the regular refresh period of the display, which is typically on the
order of 1 s, but rather to the (typically longer) interval defined above.
[3]
[SOURCE: ISO 80601-2-61:2017 , 201.3.204, modified.]
201.3.208
declared range
range of the reference haemoglobin oxygen saturation (S ) over which there is specified accuracy
R
performance
[3]
[SOURCE: ISO 80601-2-61:2017 , 201.3.202]
201.3.209
displayed range
range of StO values that can be displayed by the cerebral tissue oximeter equipment
Note 1 to entry: The displayed range can extend beyond the declared range.
[3]
[SOURCE: ISO 80601-2-61:2017 , 201.3.206, modified.]
6 © ISO 2021 – All rights reserved
ISO 80601-2-85:2021(E)
201.3.210
functional oxygen saturation
saturation given by the oxyhaemoglobin concentration (cO Hb) divided by the sum of the
oxyhaemoglobin concentration and the deoxyhaemoglobin concentration (cHHb)
cO2Hb
ccO2Hb+ HHb
[7]
Note 1 to entry: The CLSI term for this ratio is haemoglobin oxygen saturation, and its notation is SO .
[7]
[SOURCE: CLSI C46-A2: 2009, 4.1.10.2 ]
201.3.211
functional
...
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