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...
view more

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

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

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

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 functi...view more

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

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 ge...view more

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

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.

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

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...view more

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

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 followi...view more

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

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 ne...view more

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

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)...view more

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

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...view more

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

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 M...
view more

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

NEW!IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equi...view more

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

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...
view more

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

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

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

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.

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

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 cert...view more

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

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.

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

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 thi...view more

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

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 thi...view more

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

CCMC - Missing superseding note

    • sale 10% off
    • Corrigendum
      1 page
      English language
    • e-Library read for
      1 day

CCMC - Missing superseding note

    • sale 10% off
    • Corrigendum
      1 page
      English language
    • e-Library read for
      1 day

PWI created for possible future // procedures

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

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...
view more

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

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 de...
view more

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

IEC 62220-1-1:2015 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. This first edition of IEC 62220-1-1 cancels and replaces IEC 62220-1:2003. It constitutes a technical revision...view more

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

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. 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. ...view more

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

This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part...view more

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

IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. This first edition of IEC 62366-1, together with the first edition of...view more

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

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.

    • sale 10% off
    • Corrigendum
      1 page
      English language
    • e-Library read for
      1 day

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.

    • sale 10% off
    • Corrigendum
      1 page
      English language
    • e-Library read for
      1 day

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.

    • sale 10% off
    • Corrigendum
      1 page
      English language
    • e-Library read for
      1 day