IEC 61828:2020 - provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound; - relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers; - gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers; - specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers. I...view more

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IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV.
This document describes the test methods employing digital detectors for determining:
a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0;
b) LINE SPREAD FUNCTIONS;
c) one-dimensional MODULATION TRANSFER FUNCTIONS;
d) FOCAL SPOT PINHOLE RADIOGRAMS,
and the means for indicating compliance.
In info...
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      47 pages
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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser
equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications,
intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the
ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4.
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as
sources of energy being transferred to the PATIENT or animal and where the las...
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    • Standard
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This document applies to rigid endoscopes designed for use in the practice of medicine. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded. It specifies a test method for determining the optical resolution of endoscopes. This document provides a measurement method for characterizing three aspects of the optical resolution of a rigid endoscope. Characteristic A is used to provide a simple measurement of the limiting resolution of the endoscope image. Characteristic B p...view more

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    • Standard
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This document defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. This document does not define general medical terms or other general terms. This document does not define terms that should be defined in other ISO 8600 (all parts).

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      25 pages
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This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned.

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      9 pages
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      9 pages
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IEC 80601-2-26 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: - phono-photic stimulators; - EE...view more

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IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators;...view more

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    • Standard
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This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are perfor...view more

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This Standard specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all...view more

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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.

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    • Standard
      13 pages
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IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are perfo...view more

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    • Standard
      19 pages
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IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

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    • Standard
      27 pages
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IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are perfo...view more

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    • Standard
      33 pages
      English and French language

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT.
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...
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This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above norma...view more

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This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQ...view more

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IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative ref...view more

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IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for...view more

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IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

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This document applies to endoscopes designed for use in the practice of medicine. It specifies measurement requirements and describes two test methods for measuring the field of view and direction of view of endoscopes. Method A uses the distance from the distal window to calculate the field of view. Method B uses the distance from the entrance pupil. Other test methods can be used if they obtain equivalent results.

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    • Standard
      8 pages
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This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT,
which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the
BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does
not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
Th...
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This standard establishes a normative definition of communication between personal health continuous
glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal
health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work
done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application
profile standards, and transport standards. It specifies the use of specific ter...
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This document specifies the general requirements for basic performance and safety of abdominal physiological parameter detectors. It covers the material, basic parameters and testing method of abdominal parameter detectors but does not prescribe the clinical abdominal diagnosis associated with the findings obtained from the devices.

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    • Technical specification
      6 pages
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ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pu...
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Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

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    • Standard
      2 pages
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    • Standard
      2 pages
      French language

IEC 61010-2-101:2018 is also available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Worki...
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EN-IEC 80601-2-71 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles ...view more

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IEC 80601-2-71:2015(E) applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.

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IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of this document is restricted to ME equipment or medical electrical systems intended fo...
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    • Standard
      83 pages
      English and French language

SIST EN- ISO 80601-2-56 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This document specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This document applies to all electrical CLINICAL THERMOMETERS that are used for measuring the BODY TEMPERATURE of PATIENTS. CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, prin...view more

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IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph.
This edition includes the following significant technical changes with respect to the previous edition:
a) updates of the normative r...
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    • Standard
      83 pages
      English and French language

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard
establishes a normative definition of communication between personal telehealth glucose meter devices and
compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a
manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards,
including ISO/IEEE 11073 terminology, information models, application pr...
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Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devi...view more

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    • Standard
      87 pages
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Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal cardiovascular fitness and activity monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information model...view more

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ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.
Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printin...
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IEC 60601-2-28:2017 is also available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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 inte...
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      48 pages
      English and French language

ISO 19614:2017 specifies the technical requirements, classification and test method for a pulse graph force transducer, hereafter referred to as transducer. It only applies to pulse graph acquisition over the patient's radial artery based on TCM pulse condition requirements.

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      20 pages
      English language

Specifies the requirements for testing items of equipment intended for use on railway vehicles which are subsequently subjected to vibrations and chock owing to the nature of railway operational environment.

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    • Standard
      9 pages
      English and French language

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2017 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2017 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printi...view more

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    • Standard
      49 pages
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ISO/TR 13154:2017(E) provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection.
NOTE The equipment standard for screening thermographs is found in IEC 80601-2-59.

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    • Technical report
      23 pages
      English language

ISO/TR 13154:2017 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection. NOTE The equipment standard for screening thermographs is found in IEC 80601?2-59.

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    • Technical report
      23 pages
      English language

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing...view more

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    • Standard
      49 pages
      English language
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    • Standard
      51 pages
      French language

IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as w...view more

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      24 pages
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