11.040.60 - Therapy equipment
ICS 11.040.60 Details
Therapy equipment
Therapiegerate
Matériel de thérapie
Terapevtska oprema
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IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
- for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,
- used and maintained in accordance with the recommendations given in the instructions for use, and
– used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.
IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;
– Adaptive radiotherapy is added with Clause 16;
– The title reflects different implementations of radiotherapy treatment planning systems.
- Standard57 pagesEnglish languagesale 15% off
- Standard63 pagesFrench languagesale 15% off
- Standard120 pagesEnglish and French languagesale 15% off
IEC 60601-2-64:2025 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 document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified 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.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
- Standard185 pagesEnglish languagesale 15% off
2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes
- Amendment14 pagesEnglish languagesale 10% offe-Library read for1 day
2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes
- Amendment14 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• 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 80601-2-68:2024 cancels and replaces the first edition published in 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 editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be: • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • 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 80601-2-68:2024 cancels and replaces the first edition published in 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 editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.
- Standard79 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• 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 80601-2-68:2024 cancels and replaces the first edition published in 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 editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.
- Standard237 pagesEnglish languagesale 15% off
This document specifies test methods for the quality assessment of moxa floss. It covers sample preparation, measurement and calculation of the concentration of waste particle, and delivery of moxa floss quality information. This document is applicable to any moxa floss products and moxa floss used in the moxibustion devices. It is not applicable to the moxa floss which is hardened with chemical ingredients or high pressure, or both, and carbonized moxa floss which is used for smokeless moxibustion devices. Classification of quality grade of moxa floss is not specified in this document.
- Technical specification10 pagesEnglish languagesale 15% off
This document:
— defines a vaping regime for products suitable for use for a specific user inhalation behaviour: the direct to lung inhalation;
— defines the parameters, technical requirements and standard conditions for a vaping machine for direct to lung vaping products;
— specifies technical requirements of vaping devices suitable to be tested under this regime;
— specifies the conditions under which this regime is suitable for use.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
This document:
— defines a vaping regime for products suitable for use for a specific user inhalation behaviour: the direct to lung inhalation;
— defines the parameters, technical requirements and standard conditions for a vaping machine for direct to lung vaping products;
— specifies technical requirements of vaping devices suitable to be tested under this regime;
— specifies the conditions under which this regime is suitable for use.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
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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.
- Standard92 pagesEnglish languagesale 15% off
- Standard61 pagesEnglish and French languagesale 15% off
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- Standard13 pagesEnglish and French languagesale 15% off
IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).
- Standard59 pagesEnglish and French languagesale 15% off
This document specifies the requirements and test methods of single-use acupoint magnetotherapy plasters. For devices containing other medicine ingredients, this document only applies to the magnetotherapy functions of the device.
- Standard8 pagesEnglish languagesale 15% off
- Technical report3 pagesEnglish languagesale 15% off
IEC 60601-2-10:2012 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012.
- Standard42 pagesEnglish and French languagesale 15% off
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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.
- Standard64 pagesEnglish and French languagesale 15% off
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This document specifies safety controls for cupping devices used for air suction or discharge. It applies to cupping devices that contain cups made of manufactured materials, such as plastic, glass, rubber, ceramic or silicone. It does not apply to cupping devices that contain cups made from natural materials (e.g. bamboo) or those that include additional features, such as magnetism or infrared.
- Standard5 pagesEnglish languagesale 15% off
IEC TR 60878:2022 provides a 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 (see Clause 4).
IEC TR 60878:2022 cancels and replaces the third edition published in 2015. This fourth edition constitutes a technical revision.
The main changes compared with IEC TR 60878:2015 are as follows:
• A total of 109 new symbols and safety signs that have been identified since the publication of the third edition have been added. For identification, the number of the new symbol or safety sign is printed in red followed by “New”.
• Of the symbols and safety signs in the third edition, 14 have changes in their title or description. For identification, the number of a modified symbol or safety sign is printed in red followed by “Mod”.
The contents of the corrigendum of February 2023 have been included in this copy.
- Technical report226 pagesEnglish languagesale 15% off
IEC 60601-2-6:2012 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned to the third edition of IEC 60601-1:2005+A1:2012.
- Standard41 pagesEnglish and French languagesale 15% off
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IEC 60601-2-3:2012 specifies the requirements for the basic safety and essential performance of short-wave therapy equipment. Short-wave therapy equipment are defined as medical equipment for the therapeutic treatment of a patient by exposure to electric or magnetic fields produced in the frequency range of more than 13 MHz but not exceeding 45 MHz. Equipment having a rated output power not exceeding 10 W are exempted from certain requirements of this standard. This third edition cancels and replaces the second edition of IEC 60601-2-3 published in 1991 and its amendment 1 published in 1998. This edition constitutes a technical revision and has been aligned with IEC 60601-1:2005.
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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 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).
- Standard39 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general requirements for the basic safety and essential performance of electro-acupuncture (EA) stimulators. It is not applicable to acupuncture needles, transcutaneous electrical nerve stimulators or electrical nerve and muscle stimulators.
- Standard12 pagesEnglish languagesale 15% off
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 211
This standard 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 standard 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 based on reference testing methods;
- guidelines for safety of the ultrasonic field generated by 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 224 based on routine testing methods.
Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 211 This standard 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 standard 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 based on reference testing methods; - guidelines for safety of the ultrasonic field generated by 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 224 based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard.
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 61689:2022 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous (e.g. tone burst) wave ultrasound in the frequency range 0,5 MHz to 5 MHz. 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 based on reference testing methods;
- guidelines for safety of the ultrasonic field generated by 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 based on routine testing methods.
Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not within the scope of this document.
Ultrasonic physiotherapy equipment using ultrasound in the frequency range from 20 kHz to 500 kHz is dealt with in IEC 63009.
IEC 61689:2022 cancels and replaces the third edition published in 2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition.
a) The requirement on water oxygen content is specified in 6.1.
b) Former recommendations in 6.2 have been changed to become requirements.
c) Several definitions in Clause 3 have been updated in line with other TC 87 documents.
d) The formerly informative Annex A has been changed to become normative, and now contains details on how conformance with IEC 60601-2-5 requirements is checked.
e) Annex D has been considerably shortened and reference to a now withdrawn regulatory document has been removed.
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This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories:
- intended for use with patients who can breathe spontaneously; and
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.
EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.
Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Respiratory high-flow therapy equipment can be:
- fully integrated ME equipment; or
- a combination of separate items forming a ME system.
This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode.
Respiratory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.
EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.
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 the general standard, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in the general standard, 4.2.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12[14];
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[15];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[20];
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[17];
- ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[18];
- ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[19];
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16];
- continuous positive airway pressure (CPAP) ME equipment;
- high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601‑2‑87[21];
- gas mixers for medical use, which are given in ISO 11195[9];
- flowmeters, which are given in ISO 15002[11];
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[21]; and
- cuirass or “iron-lung” venti
- Standard89 pagesEnglish languagesale 15% off
- Standard89 pagesFrench languagesale 15% off
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.
- Standard118 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard118 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard7 pagesEnglish languagesale 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)
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard121 pagesEnglish languagesale 10% offe-Library read for1 day
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)
- Amendment10 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard232 pagesEnglish and French languagesale 15% off
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