M/432 - Medical Devices

IEC Corrected version

IEC Corrected version

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

EN-IEC 60601-2-50 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. This particular standard 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.

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

EN-IEC 60601-2-21 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, 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.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, 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 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, 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 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, 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. This particular standard 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 PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

IEC 60601-2-19:2020 is available as IEC 60601-2-19:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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 60601-2-19:2020 specifies safety requirements for INFANT INCUBATORS, 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 60601-2-19:2020 does not apply to: - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

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.

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

This part of IEC 60645 specifies a means of describing the physical characteristics, in terms of
electrical waveforms, of audiometric reference and test signals of short duration and methods
for their measurement.
The object of this document is to ensure that audiometric stimuli of short duration are specified
and measured in the same way and that the calibration of equipment using such signals is
carried out using defined methods.
This document does not describe the method of use of short-duration test signals.

IEC 60645-3:2020 specifies a means of describing the physical characteristics, in terms of electrical waveforms, of audiometric reference and test signals of short duration and methods for their measurement. The object of this document is to ensure that audiometric stimuli of short duration are specified and measured in the same way and that the calibration of equipment using such signals is carried out using defined methods. This document does not describe the method of use of short-duration test signals. IEC 60645-3:2020 cancels and replaces the second edition published in 2007. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) new figures of reference signals; b) changes in definitions.

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

EN-IEC 60601-2-66 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID 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 HEARING AIDS and to HEARING AID SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of HEARING AIDS or HEARING AID SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.9.2 and 201.9.6. ACCESSORIES to HEARING AIDS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. HEARING AIDS do not have a MAINS PART intended for connection to AC SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING AID SYSTEM is covered by power supply, charger or other types of ACCESSORIES. ACCESSORIES with FUNCTIONAL CONNECTION to a HEARING AID may form a HEARING AID SYSTEM. HEARING AID related ACCESSORIES that are not physically connected to the HEARING AID during NORMAL USE are not considered to be APPLIED PART, because they do not directly contribute to the INTENDED USE of the HEARING AID. Wireless programming interfaces are covered by the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. Programming interfaces with wired connection to the HEARING AID are covered by the general standard.

EN-IEC 60601-2-31 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT.

This part of IEC 60118 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.

EN-IEC 60580 specifies the performance and testing of DOSE AREA PRODUCT METERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS. This document is applicable to the following types of DOSE AREA PRODUCT METERS: a) FIELD-CLASS DOSE AREA PRODUCT METERS normally used for the measurement of DOSE AREA PRODUCTS during MEDICAL RADIOLOGICAL EXAMINATIONS; b) REFERENCE-CLASS DOSE AREA PRODUCT METERS normally used for the CALIBRATION of FIELDCLASS DOSIMETERS. The object of this document is 1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT METERS, and 2) to standardize the methods for the determination of compliance with this level of performance. Two levels of performance are specified: - a lower level of performance applying to FIELD-CLASS DOSE AREA PRODUCT METERS; - a higher level of performance applying to REFERENCE-CLASS DOSE AREA PRODUCT METERS.

IEC 60580:2019 is available as IEC 60580:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60580:2019 specifies the performance and testing of Dose Area Product Meters intended to measure Dose Area Product and/or Dose Area Product Rate to which the Patient is exposed during Medical Radiological Examinations. This document is applicable to the following types of Dose Area Product Meters: a) Field-Class Dose Area Product Meters normally used for the measurement of Dose Area Products during Medical Radiological Examinations; b) Reference-Class Dose Area Product Meters normally used for the Calibration of Field-Class Dosimeters. NOTE Reference-Class Dose Area Product Meters can be used as Field-Class Dose Area Product Meters. The object of this document is 1) to establish requirements for a satisfactory level of performance for Dose Area Product Meters, and 2) to standardize the methods for the determination of compliance with this level of performance. Two levels of performance are specified: – a lower level of performance applying to Field-Class Dose Area Product Meters; – a higher level of performance applying to Reference-Class Dose Area Product Meters. IEC 60580:2019 cancels and replaces the second edition published 2000, and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) a second class of devices is introduced with tighter uncertainty tolerances; b) this document has been expanded to include detectors other than ionization chambers; c) radiation qualities have been updated to the new definitions according to IEC 61267; d) a requirement on the linearity of the dose area product rate measurement was added; e) changed chamber light transmission requirement from 70 % to 60 %.

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 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The requirement for testing for energy reduction has been removed; b) The test for exposure to external defibrillation has been completely revised; c) The exclusion for testing ESD immunity only with respect to air discharges has been removed; d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117; e) Additional rationale for all changes.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as
PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the
supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of
whether the PD EQUIPMENT is used in a hospital or domestic environment.
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.
This document can also be applied to PD EQUIPMENT used for compensation or alleviation of
disease, injury or disability.
These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING
SOLUTION CIRCUIT.

This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is
within the scope of this particular 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 both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
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.

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.

D155/C077: BT adopted the revised Annexes ZA and ZZ to EN 60601-1-8:2007 --> publication without TC proofing

D155/C032-C033: Publication of revised Annex ZA and Annex ZZ

IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.

CCMC - Missing superseding note

CCMC - Missing superseding note

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208
and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL
ELECTRICAL 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 part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUM
EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL
FREQUENCY for the working conditions in the range of the medical application as specified by
the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well
equipped test laboratories.
NOTE 1 While not recommended, applying this standard to determine the DQE of digital X-ray imaging devices
integrated in a clinical system is not excluded as long as the requirements as set in this standard are respected.
Points of additional attention could be (for example but not exclusively) the establishment of the required RADIATION
QUALITIES, minimizing influences of scattered and back-scattered radiation, accurate AIR KERMA measurements,
positioning of the TEST DEVICE, presence of protective covers, removal of ANTI-SCATTER GRID.
This Part 1-1 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for radiographic
imaging such as, but not exclusively, CR systems, direct and indirect flat panel-detector
based systems.
It is not recommended to use this part of IEC 62220 for digital X-RAY IMAGE INTENSIFIER-based
systems.
NOTE 2 The use of this standard for X-RAY IMAGE INTENSIFER-based systems is discouraged based on the low
frequency drop, vignetting and geometrical distortion present in these devices which may put severe limitations on
the applicability of the measurement methods described in this standard.
This part of IEC 62220 is not applicable to:
– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental
radiography;
– slot scanning DIGITAL X-RAY IMAGING DEVICES;
– COMPUTED TOMOGRAPHY;
– devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac
imaging).
NOTE 3 The devices noted above are excluded because they contain many parameters (for instance, beam
qualities, geometry, time dependence, etc.) which differ from those important for RADIOGRAPHY. Some of these
techniques are treated in other parts of the IEC 62220 standards (IEC 62220-1-2 and IEC 62220-1-3).

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31
2013-08-13 - Negative assessment from Consultant

2021: CLC legacy converted by DCLab NISOSTS

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment,
where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.