M/023 - Medical devices

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

IEC 60118-13:2019 covers the relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was identified as one of the most relevant EMC phenomena impacting hearing aids. IEC 60118-13:2019 cancels and replaces the fourth edition published in 2016 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it introduces a new measurement method and set of EMC requirements for hearing aids immunity to mobile digital wireless devices; b) generic EMC requirements for hearing aids are no longer included – should be covered by other standards as appropriate.

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances; c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.

IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. 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. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1.

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

No scope available

No scope available

NEW!IEC 60601-2-2:2017 is available as IEC 60601-2-2:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories. HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - refinement and additions to the defined terms; - additional separation of the requirements for HF surgical equipment and HF surgical accessories; - a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes; - new requirements for devices that have or use a high current mode.

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)

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)

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) revision of the definition about ESSENTIAL PERFORMANCE;
b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;
c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V;
d) correction of the drop test level from 1,5 m to 1,0 m;
e) correction of the wording of IEC 60601-2-66:2015.

IEC 60118-13:2019 covers the relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was identified as one of the most relevant EMC phenomena impacting hearing aids.
IEC 60118-13:2019 cancels and replaces the fourth edition published in 2016 and constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) it introduces a new measurement method and set of EMC requirements for hearing aids immunity to mobile digital wireless devices;
b) generic EMC requirements for hearing aids are no longer included – should be covered by other standards as appropriate.

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.

2020-03-17-JO- BT decision BT164/DG11529/DV to remove the link to the MDD (93/42/EEC)
Publication on hold due to negative assessment

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.

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

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.

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of 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, 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. Key words: nuclear medicine, radiation dosimetry.

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. 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; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

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.

IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of 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, 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.
Key words: nuclear medicine, radiation dosimetry.

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. 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; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.

IEC 60601-2-57:2011 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 non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

IEC 60601-2-57:2011 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 non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

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).

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).

D127/107: Project under Benchemark 6 * Extension of target date approved until 2007-09-12 (no more extension allowed) * TC 62 decision on 2006-10-24: prEN 50447 deleted from work programme due to lack of sustained interest from stakeholders

D127/107: Project under Benchemark 6 * Extension of target date approved until 2007-09-12 (no more extension allowed) * TC 62 decision on 2006-10-24: prEN 50447 deleted from work programme due to lack of sustained interest from stakeholders * D129/C066: Cancellation of project confirmed * Standstill released

Defines the concept of permanent filtration in X-ray tube assemblies for medical diagnosis and radiotherapy and describes a method for its determination. It contains requirements for statements of compliance for accompanying documents and for markings on X-ray tube assemblies. Methods are given to determine the permanent filtration in an X-ray tube assembly with an accuracy that is sufficient to enable the appropriate additional filtration to be provided in order to attain the desired total filtration.

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.

EN following parallel vote

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. The aim of this second edition is to bring this particular standard up to date with reference to publications EN 60601-1 (1988) including the amendments 1 (1991) and 2 (1995), EN 60601-1-2 (1993) and EN 61689 (1996).

Specifies the particular safety requirements for electrocardiographs, intended for the production of detachable electrocardiograms for diagnostic purposes. Also applies to vectorcardiographs and equipment for stress testing.

Establishes particular requirements for the safety of endoscopic equipment and enables parts of endoscopic equipment to be tested together or individually.

Establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy and defines type tests and site tests. Places limits on the degradation of 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 equipment.

IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. Hazards inherent in the intended physiological function of hearing instruments or hearing instrument systems within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Accessories connected to a hearing instrument may form a hearing instrument system. Only the hearing instrument and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the hearing instrument system are subject to requirements of this particular standard that result from their connection to the hearing instrument system. This standard does not apply to:  - cochlear implants or other implanted hearing instruments;  - bone conduction hearing instruments;  - educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.);  - the application of a hearing instrument for the measurement of hearing levels. IEC 60645-1 applies;  - audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;  - assisted hearing instrument systems using infra-red or radio;  - and the sound generating function of a tinnitus masker.

Applies to the safety of equipment for extracorporeally induced lithotripsy, i.e. device for treatment with extracorporally generated pressure pulses. The applicability of this 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.

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.

Specifies the particular safety requirements for ambulatory electrocardiographic systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the above- mentioned categories.

EN following parallel vote

This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements.

Specifies the requirements for infusion pumps, infusion controllers, syringe pumps and pumps for ambulatory use. These devices are intended for use by medical staff and home patients as prescribed and medically indicated. It is the responsibility of the manufacturer to ensure that the requirements of this standard are reliably implemented.

EN following parallel vote

Specifies the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.