M/575 AMD 2 - Medical Devices (MDR-IVDR)

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 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator.
This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.
This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes.
The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.
This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.
This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input.
This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.
This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.
IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision.
Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document.
This edition includes the following significant technical changes with respect to previous editions:
a) the default use of an acoustic coupler according to IEC 60318-5,
b) addition of the optional use of an occluded ear simulator according to IEC 60318-4,
c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids,
d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes,
e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration,
f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator. This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets. This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes. The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use. This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used. This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input. This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied. This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied. IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision. Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document. This edition includes the following significant technical changes with respect to previous editions: a) the default use of an acoustic coupler according to IEC 60318-5, b) addition of the optional use of an occluded ear simulator according to IEC 60318-4, c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids, d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes, e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration, f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

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)

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.
The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered). These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

The amendment to EN IEC 60601-2-22:2020 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered). These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

The amendment to EN IEC 60601-2-22:2020 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

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).