Infoteenus
11 TERVISEHOOLDUS
Uued standardid
EVS-EN ISO 21388-1:2026
Acoustics - Hearing aid fitting management (HAFM) - Part 1: General process (ISO 21388-1:2026)
Käsitlusala: This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
Alusdokumendid: ISO 21388-1:2026; EN ISO 21388-1:2026
Asendab: EVS-EN ISO 21388:2021
EVS-EN ISO 11607-3:2026
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO 11607-3:2026)
Käsitlusala:
This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.
This document applies to both preformed sterile barrier systems and sterile barrier systems.
This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.
This document is intended to be used prior to process validation.
NOTE ISO 11607-2 provides requirements for process specification and process validation.
Alusdokumendid: ISO 11607-3:2026; EN ISO 11607-3:2026
ISO 21366:2026
Traditional Chinese medicine — General requirements for smokeless moxibustion devices
Käsitlusala: This document specifies general requirements for the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices.
This document is applicable to any combustion-type device that claims to provide smokeless moxibustion.
This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
This document is applicable to any combustion-type device that claims to provide smokeless moxibustion.
This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
Alusdokumendid:
Asendab: ISO 21366:2019
IEC 60601-2-4:2010+AMD1:2018+AMD2:2026 CSV
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Käsitlusala: IEC 60601-2-4:2010+AMD1:2018+AMD2:2026 CSV establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.
Alusdokumendid:
ISO 20255:2026
Traditional Chinese medicine — Epimedium brevicorum, Epimedium sagittatum, Epimedium pubescens, and Epimedium koreanum herb
Käsitlusala: This document specifies the minimum requirements and test methods for wild and cultivated Epimedium herb.
This document applies to Epimedium herb that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document applies to Epimedium herb that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Alusdokumendid:
IEC 60601-2-4:2010/AMD2:2026
Amendment 2 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Käsitlusala: Amendment to IEC 60601-2-4:2010
Alusdokumendid:
Asendatud standardid
ISO 21366:2019
Traditional Chinese medicine -- General requirements for smokeless moxibustion devices
Käsitlusala: This document specifies general requirements to ensure the performance and safety of smokeless moxibustion devices. It covers smoke density, moxibustion temperature, noxious gas and test methods for smokeless moxibustion devices.
This document is applicable to any combustion-type device that claims to provide smokeless moxibustion.
This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
This document is applicable to any combustion-type device that claims to provide smokeless moxibustion.
This document does not apply to devices that imitate moxibustion, such as electro moxibustion and infrared moxibustion devices.
Alusdokumendid:
Asendatud: ISO 21366:2026
EVS-EN ISO 21388:2021
Acoustics - Hearing aid fitting management (HAFM) (ISO 21388:2020)
Käsitlusala: This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
Alusdokumendid: ISO 21388:2020; EN ISO 21388:2021
Asendatud: EVS-EN ISO 21388-1:2026
Kavandid
prEN ISO 15883-4
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO/DIS 15883-4:2026)
Käsitlusala: This document specifies the particular requirements, including performance criteria for washer-disinfectors
(WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories which can be required to achieve the necessary performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.
NOTE 2 WD conforming with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.
WD conforming with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2024, 4.1.5).
NOTE 3 The specified performance requirements of this document cannot ensure the inactivation or removal of the
causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 4 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein or other protein in a manner that can inhibit its removal or inactivation from the load or WD.
NOTE 5 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
(WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories which can be required to achieve the necessary performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.
NOTE 2 WD conforming with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.
WD conforming with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2024, 4.1.5).
NOTE 3 The specified performance requirements of this document cannot ensure the inactivation or removal of the
causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 4 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein or other protein in a manner that can inhibit its removal or inactivation from the load or WD.
NOTE 5 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
Alusdokumendid: ISO/DIS 15883-4; prEN ISO 15883-4
prEN ISO 5359
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO/DIS 5359:2026)
Käsitlusala: ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies. It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools. Nor does it specify the intended uses of hose assemblies.
Alusdokumendid: ISO/DIS 5359; prEN ISO 5359
prEN ISO 18082
Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO/DIS 18082:2026)
Käsitlusala: ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute.
ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases:
— oxygen;
— nitrous oxide;
— medical air;
— helium;
— carbon dioxide;
— xenon;
— specified mixtures of the gases listed above;
— oxygen-enriched air;
— air for driving surgical tools;
— nitrogen for driving surgical tools;
use with vacuum.
ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases:
— oxygen;
— nitrous oxide;
— medical air;
— helium;
— carbon dioxide;
— xenon;
— specified mixtures of the gases listed above;
— oxygen-enriched air;
— air for driving surgical tools;
— nitrogen for driving surgical tools;
use with vacuum.
Alusdokumendid: ISO/DIS 18082; prEN ISO 18082