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
      33 pages
      English language
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IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIP...
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    • Standard
      232 pages
      English and French language

This document is applicable to
– therapy equipment using extracorporeally induced non-focused or weakly focused pressure
pulses;
– therapy equipment producing extracorporeally induced non-focused or weakly focused
mechanical energy,
where the pressure pulses are released as single events of duration up to 25 μs.
This document does not apply to
– therapy equipment using focusing pressure pulse sources such as extracorporeal
lithotripsy equipment;
– therapy equipment using other acoustic ...
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      64 pages
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IEC 60601-2-50:2020 is available as IEC 60601-2-50:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-50:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title an...
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    • Standard
      61 pages
      English and French language

This document specifies the requirements for the glass cupping device applying negative pressure created by a heat source placed in its inner cavity. This document includes the requirements for configuration, material, performance, packaging and labelling, as well as appropriate test methods. This document applies to single-use and multiple-use glass cupping devices. This document does not apply to the air extraction cupping device covered by ISO 19611.

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    • Standard
      8 pages
      English language
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    • Draft
      8 pages
      English language

EN-IEC 62386-105 applies to control gear and control devices.Typically, a bus unit according to IEC 62386 (all parts) contains firmware. There arecircumstances where it might be necessary to change the firmware after production orshipping of the product. For example if the bus unit does not operate as intended. In such acase, a firmware update of a bus unit via the interface is beneficial.This firmware update process is primarily designed to be a bug fix process, not a featureextension process. ...view more

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      79 pages
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EN-IEC 60601-2-83 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser. 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, th...view more

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      34 pages
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IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser.

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      34 pages
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IEC TR 63183:2019 provides guidance on the usage and form of error or warning messages written for software used in RADIOTHERAPY. It does not replace any requirements existing in the safety standards but is meant to be used as a supplement to existing standards on usability by providing specific examples in the field of RADIOTHERAPY.
The two main goals of this document are
1) to present in a concise manner the best practices and design guidelines for good message dialogs, and
2) to illustrate...
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    • Technical report
      24 pages
      English language

This Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. This document only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This document specifies: - methods of measurement and characterization of the output of ultrasonic physiot...view more

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IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-22:2019 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...view more

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    • Standard
      62 pages
      English and French language

IEC 63009:2019 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz. This document only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This document specifies: • methods of measurement and characterization of the output of ultrasonic physio...view more

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    • Standard
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IEC 63009:2019 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating ultrasound in the frequency range 20 kHz to 500 kHz.
This document only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head.
This document specifies:
• methods of measurement and characterization of the output of ultrasonic phy...
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    • Standard
      73 pages
      English and French language

This document specifies the requirements and test methods for therapeutic fumigation devices, hereafter referred to as the device. This document does not apply to decoction pieces.

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    • Standard
      8 pages
      English language

IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.
The scope of this document includes all light sources except laser.

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    • Standard
      64 pages
      English and French language

IEC TS 63042-201:2018(E), which is a Technical Specification, provides common rules for the design of substations with the highest voltages of AC transmission systems exceeding 800 kV, so as to provide safety and proper functioning for the intended use.

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    • Technical specification
      60 pages
      English language

IEC TS 60904-13:2018(E) specifies methods to:
capture electroluminescence images of photovoltaic modules,
process images to obtain metrics about the images taken in quantitative terms, and
provide guidance to qualitatively interpret the images for features in the image that are observed.  This document is applicable to PV modules measured with a power supply that places the cells in the modules in forward bias.

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    • Technical specification
      40 pages
      English language

This document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in
human medical practice.
This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an
ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the
MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.
This document specifies test procedures for the determination and discl...
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IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice. This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n. This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests. This document specifies test procedures for the determination and disclosure...view more

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    • Standard
      121 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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      90 pages
      English language

IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice.
This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests.
This document specifies test procedures for the determination and disclos...
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      241 pages
      English and French language

IEC TS 62462:2017(E) describes methods meant to assist users of ultrasound physiotherapy systems in checking the performance of such systems. It is applicable primarily to physiotherapists, general medical practitioners, chiropractors, osteopaths, beauty therapists, sports professionals, biomedical engineers, medical physicists, medical device service agents, commercial testers, test houses or manufacturers. This new edition includes the following significant technical change with respect to the...view more

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      30 pages
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IEC 60364-7-721:2017 lays down particular requirements applying to electrical circuits and equipment intended for the use of the caravan for habitation purposes. This new edition includes the following significant technical changes with respect to the previous edition:
- a minimum height of not less than 500 mm above the base of the cylinders is now required for cables passing through the gas cylinder compartment;
- it is now required that each independent installation shall be provided with i...
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      51 pages
      English and French language

IEC TS 62965:2016 which is a Technical Specification, specifies a minimum set of dimensional requirements for fusion splice on connectors (FSOCs) ferrule assemblies and the interface dimensions of splicing tools to ensure that a compliant ferrule assembly is compatible with a compliant fusion splicer. This fusion splicer interface also provides an example of the dimensional requirements for a universal holder, into which an FSOC can be mounted. This fusion splicer interface applies to FSOCs with...view more

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      22 pages
      English and French language

Contains a series of revisions to IEC 60601-2-3 (second edition, 1991) taking into account amendments 1 and 2 of the General Standard, which include reference to the collateral standards.

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    • Standard
      2 pages
      English language

Applies to radiotherapy simulators:[
]- that use diagnostic X-ray equipment to simulate physically a therapeutic radiation beam, so that the treatment volume to be subjected to irradiation during radiotherapy can be localized, and the position and size of the radiotherapy radiation field can be confirmed;[
]- intended exclusively for radiotherapy simulation as a prelude to intended radiotherapy, and not for any other purpose such as general diagnostic examinations.[
]Establishes require...
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      12 pages
      English and French language

Specifies the performance and some related constructional requirements of diagnostic dosimeters intended for the measurement of air Kerma, air Kerma length or air Kerma rate, in photon radiation fields used in radiography, including mammography, radioscopy and computed tomography (CT), for X-rays with generating potentials not greater than 150 kV.

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    • Standard
      8 pages
      English and French language

Gives guidance on procedures for testing the effectiveness of devices which are used to reduce the hazards of an explosion, together with the protective measures to be taken.

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    • Standard
      5 pages
      English and French language

IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition published in 2000. This edition constitu...view more

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    • Standard
      37 pages
      English language
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IEC 60601-2-5:2009 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition published in 2000. This edition constitu...view more

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IEC 62467-1:2009 specifies the performance and some related constructional requirements of well-type ionization chambers and associated measurement apparatus, intended for the determination of a quantity, such as air kerma strength or reference air kerma rate in photon radiation fields or absorbed dose to water at a depth, in photon and beta radiation fields used in brachytherapy, after appropriate calibration for a given type of source. IEC 62467-1:2009 covers the techniques for the quantificat...view more

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      28 pages
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IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essenti...view more

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      68 pages
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IEC TR 60878:2015 provides a comprehensive compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment. The graphical symbols are grouped in sections according to their specific field of application. This third edition cancels and replaces the second edition published in 2003. This third edition constitutes a technical revision.

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    • Technical report
      283 pages
      English and French language

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA
BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment,
hereafter referred to as ME 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 releva...
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      53 pages
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH
INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as
ME EQUIPMENT.
This International Standard adds or replaces clauses listed in the IEC 60601-1 that are
specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND 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 claus...
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This International Standard specifies requirements for the safety of MICROWAVE THERAPY
EQUIPMENT used in medical practice, as defined in 201.3.204.

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      23 pages
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This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for
EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for
other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES,
hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to
components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the
generator of the PRESSURE PULSE, PA...
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME 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 ...
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    • Standard
      50 pages
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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT
ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
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.
This particular standard,...
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This particular standard specifies the requirements for the safety of SHORT-WAVE THERAPY
EQUIPMENT, hereafter referred to as ME EQUIPMENT, as defined in subclause 201.3.206.
LOW POWER EQUIPMENT as defined in subclause 201.3.202 is exempted from certain
requirements of this standard.

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