This document specifies requirements and test methods for laser acupoint devices. This document is not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the laser features.

  • Standard
    7 pages
    English language
    sale 15% off
  • Draft
    7 pages
    English language
    sale 15% off

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

  • Amendment
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 lasers are
specified as above, are referred to as “laser equipment” in this document.
NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or
CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general 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 to ME EQUIPMENT and to ME SYSTEMS, as relevant.
Hazards inherent in the intended physiological function of laser equipment within the scope of
this document are not covered by specific requirements in this document except in 7.2.13,
Physiological effects, of the general standard.

  • Standard
    33 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
• maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new relevant collateral standards;
b) addition of computer interface and control;
c) addition of new technologies in RADIOTHERAPY, including
• BEAM GATING, and
• ADAPTIVE RADIOTHERAPY.

  • Standard
    232 pages
    English and French language
    sale 15% off

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 waveforms like physiotherapy equipment, low
intensity ultrasound equipment and HIFU/HITU equipment.
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of
extracorporeal equipment producing a non-focused or weakly focused pressure pulse
field,
– methods of measurement and characterization of non-focused or weakly focused
pressure pulse fields.
NOTE 1 The parameters defined in this document do not – at the time of publication – allow quantitative statements
to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the
limits for these effects.
NOTE 2 Figure B.1 to Figure B.10 and Figure 2 to Figure 4 are useful to understand the geometry of the field
applied in this document.
This document has been developed for equipment intended for use in pressure pulse therapy,
for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain,
muscular trigger point therapy, lower back pain, etc. It is not intended to be used for
extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment
using other waveforms (as described in IEC 61689) and HIFU/HITU equipment (see
IEC 60601-2-62 and IEC TR 62649).

  • Standard
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 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 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-50:2020 specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
IEC 60601-2-50:2020 does not apply to:
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21.
IEC 60601-2-50:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-50:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

  • Standard
    61 pages
    English and French language
    sale 15% off

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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Draft
    8 pages
    English language
    sale 15% off

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. Nevertheless the firmware update process can be used for featureextensions. But it is important that the risk of negative effects to the complete system isconsidered in detail.

  • Standard
    79 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 these design guidelines with specific examples from the field of radiation oncology.
This document is intended to be read by the following MANUFACTURERS’ employees and representatives:
– engineering department members including: software engineers, RISK managers, quality assurance engineers, technical writers, etc.;
– usability and human factors engineers;
– marketing representatives (product marketing, product managers, business analysts).
Throughout this document, unless specifically called out, these guidelines apply to all categories of messages summarily called error or warning messages (e.g. critical error, warning, system status, informational, routine interlock messages).

  • Technical report
    24 pages
    English language
    sale 15% off

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 physiotherapy equipment based on reference testing methods; - characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment; - methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; - acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment. The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document. Excluded equipment includes, but is not limited to: - equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type; - equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters); - equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy); - equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 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 lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, are covered by IEC 60825-1:2014 and by the general 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 to ME Equipment and to ME Systems, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. If the laser equipment is Class 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition;
b) it addresses technical and safety issues which have arisen since publication of the third edition;
c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4;
d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.

  • Standard
    62 pages
    English and French language
    sale 15% off

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 physiotherapy equipment based on reference testing methods; • characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment; • methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; • acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment. The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document. Excluded equipment includes, but is not limited to: • equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type; • equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters); • equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy); • equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 physiotherapy equipment based on reference testing methods;
• characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment;
• methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods;
• acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment.
The therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document.
Excluded equipment includes, but is not limited to:
• equipment in which ultrasound waves are intended to destroy conglomerates (for example stones in the kidneys or the bladder) or tissue of any type;
• equipment in which a tool is driven by ultrasound (for example surgical scalpels, phacoemulsifiers, dental scalers or intracorporeal lithotripters);
• equipment in which ultrasound waves are intended to sensitize tissue to further therapies (for example radiation or chemotherapy);
• equipment in which ultrasound waves are intended to treat cancerous (i.e., malignant) or pre-cancerous tissue, or benign masses, such as High Intensity Focused Ultrasound (HIFU) or High Intensity Therapeutic Ultrasound (HITU).

  • Standard
    73 pages
    English and French language
    sale 15% off

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.

  • Standard
    8 pages
    English language
    sale 15% off

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.

  • Standard
    64 pages
    English and French language
    sale 15% off

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.

  • Technical specification
    60 pages
    English language
    sale 15% off

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.

  • Technical specification
    40 pages
    English language
    sale 15% off

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 disclosure of performance
characteristics, knowledge of which is necessary for proper selection, application, and use of
LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING
DOCUMENTATION together with the greatest deviation or variation to be expected under specific
conditions in NORMAL USE. A format for presentation of performance values is given in
Annex A.
It is recognized that inaccuracies in the test methods can occur when assessing performance.
However, it was felt preferable not to combine the errors into an overall performance
tolerance but rather to keep them separate in the expectation that more accurate test methods
will evolve.
It is not intended that this document in any way inhibit the future development of new designs
of equipment which may have operating modes and parameters different from those described
herein, provided that such equipment achieves equivalent or better levels of performance for
the TREATMENT of PATIENTS.
This document applies to both ISOCENTRIC and non-ISOCENTRIC GANTRIES but many of the tests
assume that the LIGHT ION BEAM ME EQUIPMENT has an ISOCENTRIC GANTRY. Where the
equipment is non-ISOCENTRIC, the description of performance and test methods may be
suitably adapted.

  • Standard
    121 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

  • Standard
    121 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
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 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance.
ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 2 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.
ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.
ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

  • Standard
    90 pages
    English language
    sale 15% off

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 of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

  • Standard
    241 pages
    English and French language
    sale 15% off

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 previous edition: it includes a novel method for periodic testing regarding possible changes of the effective radiating area using thermochromic absorbers in a new Annex E.

  • Technical specification
    30 pages
    English language
    sale 15% off

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 its own main isolating switch which shall disconnect all live conductors and which shall be suitably placed in a readily accessible location in the caravan.

  • Standard
    51 pages
    English and French language
    sale 15% off

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 a cylindrical ferrule of 2,5 mm diameter or 1,25 mm diameter. Keywords: FSOC, fusion splicer interface

  • Technical specification
    22 pages
    English and French language
    sale 15% off

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.

  • Standard
    2 pages
    English language
    sale 15% off

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 requirements to ensure the ionizing radiation safety and enhanced mechanical and electrical safety of radiotherapy simulators; it identifies geometrical parameters that are critical for the accurate simulation of a radiotherapy treatment.[
]Cancels and replaces the first edition published in 1993 and its amendment 1 (1996).

  • Standard
    12 pages
    English and French language
    sale 15% off

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.

  • Standard
    8 pages
    English and French language
    sale 15% off

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.

  • Standard
    5 pages
    English and French language
    sale 15% off

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 constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 constitutes a technical revision. The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this, essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in 201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to allow for simulated use conditions. Measurements of ultrasound-related parameters are now referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-related parameters is the definition of effective radiating area, 201.3.207. This change will also affect the value of the effective intensity and its uncertainty.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 quantification of the quantity appropriate for the brachytherapy source under consideration. This quantity may be air kerma strength or reference air kerma rate at 1 m, or absorbed dose to water at a depth (e.g. 2 mm or 5 mm). Measurement of these quantities may be accomplished by a variety of well-type ionization chambers or systems currently available for this purpose. This standard applies to products intended for low dose rate, high dose rate, intravascular, both photon and beta, brachytherapy measurements. It does not apply to instruments for nuclear medicine applications. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors. The intended use is the measurement of the output of radioactive, encapsulated sources for intracavitary (insertion into body cavities) or interstitial (insertion into body tissue) applications. The object of IEC 62467-1:2009 is a) to establish requirements for a satisfactory level of performance for well-type chamber systems, and b) to standardize the methods for the determination of compliance with this level of performance. IEC 62467-1:2009 is not concerned with the safety aspects of well-type chamber systems. The well-type chamber systems covered by this standard are not intended for use in patient environment. The electrical safety of well-type chamber systems is covered in IEC 61010-1. The operation of the electrometer measuring system is covered in IEC 60731.

  • Standard
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions: - alignment with the new relevant collateral standards; - new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

  • Standard
    68 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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.

  • Technical report
    283 pages
    English and French language
    sale 15% off

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, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the
selection and DISPLAY of operating parameters can be controlled automatically by
PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in
the range 10 MeV/n to 500 MeV/n,
and
– intended to be
– for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application,
for particular SPECIFIED clinical purposes maintained in accordance with the
recommendations given in the INSTRUCTIONS FOR USE,
– subject to regular quality assurance performance and calibration checks by a QUALIFIED
PERSON.
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE
ORGANIZATION’S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their
zero positions and the direction of movement with increasing value (see 201.7.4.101).

  • Standard
    58 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT used for treatment or alleviation of disease.
This standard specifies requirements
a) for automatically-controlled AFTERLOADING ME EQUIPMENT
1) which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT,
2) which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location,
3) which is designed for connection to a PATIENT, and
4) with which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems and
b) for ME EQUIPMENT intended to be 1) for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. remote AFTERLOADING BRACHYTHERAPY;
2) maintained in accordance within the recommendations given in the INSTRUCTIONS FOR USE;
3) subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
This standard does not specify requirements for SEALED RADIOACTIVE SOURCES. Requirements
for the design of X-RAY TUBES used with the ME EQUIPMENT are specified in other IEC standards. See for example: IEC 60601-2-28:2010.
The requirements of this standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
– the SOURCE STRENGTH(S) or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE(S)
used by the ME EQUIPMENT is (are) known.
This standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the ME EQUIPMENT, in particular that:
– the selected RADIATION SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
– IRRADIATION is performed by the selected RADIATION SOURCE configuration for the selected duration;
– IRRADIATION is performed by the ME EQUIPMENT without causing unnecessary RISK to the OPERATOR or other persons in the immediate surroundings.

  • Standard
    50 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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, PATIENT support device, and their interactions with imaging
and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray
and ultrasonic devices, are excluded from this standard, because they are treated in other
applicable IEC standards.
This particular standard does not apply to:
– ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy;
– ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND
(HITU) and other therapy equipment as described in Annex AA;

  • Standard
    24 pages
    English language
    sale 10% off
    e-Library read for
    1 day

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 relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.

  • Standard
    53 pages
    English language
    sale 10% off
    e-Library read for
    1 day

This International Standard specifies requirements for the safety of MICROWAVE THERAPY
EQUIPMENT used in medical practice, as defined in 201.3.204.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day