11.040 - Medical equipment
ICS 11.040 Details
Medical equipment
Medizinische Gerate
Materiel medical
Medicinska oprema
General Information
Frequently Asked Questions
ICS 11.040 is a classification code in the International Classification for Standards (ICS) system. It covers "Medical equipment". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 6612 standards classified under ICS 11.040 (Medical equipment). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies general requirements for the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices. This document is applicable to any combustion-type device that claims to provide smokeless moxibustion. This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the general requirements for basic safety and essential performance of electric radial pulse tonometric devices. This document does not apply to the accuracy of differential diagnosis or interpretation of the diagnostic data obtained from the use of such devices. This document applies to pressure-based radial pulse tonometric devices.
- Standard9 pagesEnglish languagesale 15% off
This document specifies general requirements for the basic safety and essential performance of transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate acupoints on the human body. It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context of professional traditional Chinese medicine (TCM) healthcare services. It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via acupuncture needles inserted into the body.
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- Amendment10 pagesEnglish languagee-Library read for1 day
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IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.
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This document specifies the general requirements and test methods of Chuzhen instruments. It is only applicable to non-disposable Chuzhen instruments. It is not applicable for any disposable Chuzhen instruments or for those with electrical, heat-storing, or other special characteristics.
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This document defines terms for surgical instruments and their components.
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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
- Standard30 pagesEnglish languagee-Library read for1 day
This document describes a wear testing method of anatomic total shoulder-joint prostheses that specifies relative motion between the implant components and the pattern of the applied forces. This document includes the basic configuration of the simulator, sample number and alignment, test environment, speed and duration of testing, verification of inputs, measurement of kinematics and other details of the procedure and reporting. The primary outcome is the evaluation of wear performance of total anatomic shoulder-joint prostheses, which includes both qualitative and quantitative methods. The qualitative methods of wear evaluation are included in this document and the methods of quantitative wear measurement are covered in ISO 14243-2.
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This document specifies the material, performance requirements and labelling, and gives recommendations for shape and dimensions of glass cylinders used in cartridge-type needle-based injection systems (NIS) for medical use, according to ISO 11608-3. This document applies to the glass cylinders as supplied by the manufacturer.
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This document specifies methods by which the measurement of irradiance (fluence) distribution is made and specifies parameters for the characterization of the spatial properties of laser irradiance (fluence) distribution functions at a given plane.
The methods given in this document are intended to be used for the testing and characterization of both continuous wave (cw) and pulsed laser beams used in optics and optical instruments.
This document provides definitions of terms and symbols to be used in referring to irradiance distribution, as well as requirements for its measurement. For pulsed lasers, the distribution of time-integrated irradiance (i.e. radiant exposure) is the quantity most often measured.
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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2[1]1 and IEC 60601-2-76[2]).
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This document provides vocabularies and definitions for moxibustion devices. This document is not applicable to moxibustion-like devices whose heat source is not combustion, e.g. electric moxibustion devices.
- Technical specification8 pagesEnglish languagesale 15% off
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have electrogram sensing and pacing functions with or without defibrillation capability. This document includes requirements for the connector portion of an implantable lead and for the mating connector cavity attached to an implantable pulse generator. Key dimensions and performance requirements are specified together with appropriate test methods. This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable: a high-voltage connector: a connector that can have either two low-voltage contacts combined with one or two high-voltage contacts, or only two high-voltage contacts; a “low-voltage only connector”: a connector that has either three or four low-voltage contacts. This document specifies a dimensional lockout feature that prevents the low-voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities. This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318[2] and ISO 5841-3[1]). This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions. This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to Annex P for more information on connector-related products. NOTE 1 The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. NOTE 2 Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
- Standard107 pagesEnglish languagesale 15% off
This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.
The cleaning classification category is comprised of two parts:
designate medical devices to a product family;
designate product families to cleaning processes.
NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.
This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.
This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.
NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.
NOTE 3 Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.
- Technical specification20 pagesEnglish languagee-Library read for1 day
This document specifies optical and non-optical requirements and the test methods for anti-reflective and hydrophobic properties of coatings on spectacle lenses.
This document does not apply to the following topics:
requirements and test methods incorporated in other ISO 8980 series standards;
the colour of the reflected light.
- Standard29 pagesEnglish languagee-Library read for1 day
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification41 pagesEnglish languagee-Library read for1 day
This document specifies optical and non-optical requirements and the test methods for anti-reflective and hydrophobic properties of coatings on spectacle lenses.
This document does not apply to the following topics:
requirements and test methods incorporated in other ISO 8980 series standards;
the colour of the reflected light.
- Standard29 pagesEnglish languagee-Library read for1 day
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This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
— respiratory;
— enteral;
— limb cuff inflation;
— neural;
— intravascular or hypodermic;
— other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard55 pagesEnglish languagee-Library read for1 day
This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.
- Standard33 pagesEnglish languagee-Library read for1 day
This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).
- Standard22 pagesEnglish languagee-Library read for1 day
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification41 pagesEnglish languagee-Library read for1 day
This document specifies optical and non-optical requirements and the test methods for anti-reflective and hydrophobic properties of coatings on spectacle lenses. This document does not apply to the following topics: requirements and test methods incorporated in other ISO 8980 series standards; the colour of the reflected light.
- Standard22 pagesEnglish languagesale 15% off
- Standard23 pagesFrench languagesale 15% off
This document defines test methods for surgical standard instruments. This document does not cover instruments for use on the central nervous system and on the central cardiovascular system.
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IEC 60601-2-91:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2 and IEC 60601-2-76).
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- Standard53 pagesEnglish and French languagesale 15% off
This document specifies methods for the determination of basic measurements of surgical standard instruments. This document does not apply to instruments for use on the central nervous system and on the central cardiovascular system. NOTE Instruments for use on the central nervous system and on the central cardiovascular system are measured differently due to complex geometries which are adapted to the human anatomy.
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This document specifies the requirements for implementation of a quality system along the patient pathway in radiology services. The objective is to ensure high quality delivery of all aspects of the examination safety and patient care.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.
- Standard52 pagesEnglish languagee-Library read for1 day
This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification32 pagesEnglish languagesale 15% off
ISO TS 24971-2:2026 This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.
- Technical specification32 pagesEnglish languagesale 15% off
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE 1 In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.
NOTE 2 Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3 Annex F provides recommendations regarding sustainability.
NOTE 4 Annex G provides information on attributive and variable testing.
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This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on syringe barrel components addressed in ISO 11040-4 or ISO 11040-6, together with a plunger stopper (sealing the back end) based on components addressed in ISO 11040-5 and a front end closure for parenteral preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods. Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document. NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes. NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts). NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4]. NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.
- Standard22 pagesEnglish languagesale 15% off
This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).
- Standard22 pagesEnglish languagee-Library read for1 day
This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.
- Standard33 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for implementation of a quality system along the patient pathway in radiology services. The objective is to ensure high quality delivery of all aspects of the examination safety and patient care.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.
- Standard52 pagesEnglish languagee-Library read for1 day
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
— respiratory;
— enteral;
— limb cuff inflation;
— neural;
— intravascular or hypodermic;
— other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard55 pagesEnglish languagee-Library read for1 day
This document specifies quality requirements for the chart, test procedure and acceptance level for near, far, and colour vision acuity of NDT personnel. Information for grey scale perception and low contrast can be found in the annexes. This document also specifies the qualification requirements for personnel permitted to carry out the test.
This document is only applicable to vision acuity under defined conditions similar to those encountered during routine NDT inspection. This document does not address an individual’s overall visual acuity and users are advised to consider the need for a general eye examination by specialist medical personnel to ensure general vision acuity.
- Standard27 pagesEnglish languagee-Library read for1 day
This document specifies requirements for oropharyngeal airways. This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1]. The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190). The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).
- Standard14 pagesEnglish languagesale 15% off
- Standard14 pagesFrench languagesale 15% off
- Amendment8 pagesEnglish languagee-Library read for1 day
This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode. NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient. This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document. This document specifies additional disclosure requirements. This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59. This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution. NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.
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