IEC SRD 63426:2024 classifies elements suitable for an AAL connected home environment based on AAL system components. This document defines instances which are specific examples of elements used in an AAL connected home environment (AAL CHE).
An element defined in this document is a specialized and subdivided classification of a connected home environment. An instance is a specific example of an element used in an AAL CHE.
This document lists standards applicable to AAL CHE elements and AAL CHE instances, with a focus on interoperability and connectivity.

  • Standardization document
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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM)
services offered by hearing aid professionals (HAP). It focusses on tele-services which may substitute,
or complement services defined in ISO 21388, and it defines services which shall be provided in the
facilities of the HAP. Moreover, this document specifies important preconditions such as education,
facilities and systems that are required to ensure proper tele-services. If not other stated all definitions
and requirements of ISO 21388 also apply for this standard without further notice. Furthermore, it is
tried to keep the structure if ISO 21388 to make it easier to use both standards together. 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.
Other assisted tele-services provided by non-hearing aid professionals, self-fitting, and other nonhearing
care related will also be outside of the scope.

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This document provides guidance on essential social welfare services and medical support for socially vulnerable groups, who are likely to be in greater danger in the event of a respiratory epidemic disaster. This document applies to those: a) providing essential social welfare services for socially vulnerable groups in the event of a respiratory epidemic disaster; b) providing essential medical support for socially vulnerable groups in the event of a respiratory epidemic disaster.

  • Technical specification
    11 pages
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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. 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.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

  • Standard
    20 pages
    English language
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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP. Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. 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. Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

  • Standard
    12 pages
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  • Standard
    13 pages
    French language
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This document provides guidance for the daily activities to practice social distancing and source control as pre-emptive actions to prevent infectious disease.

  • Standard
    11 pages
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IEC SRD 63473:2024 is to describe the process of building an inventory of international standards based on use cases, mapping these international standards to individual use cases, and providing a visual representation in the IEC mapping platform.
This document identifies the main categories of international standards applicable to AAL systems and applies these international standards to AAL components and the complete AAL system.
Although there are national and regional standards that can address parts of AAL systems, this document will focus only on standards developed at the international level (e.g., IEC, ISO, ITU‑T).

  • Standardization document
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This document provides guidelines to prevent cross-infections within a hospital, with a specific focus on the separate operation of wards dedicated to highly contagious respiratory infectious diseases, transportation of confirmed cases of highly contagious respiratory infectious diseases, disinfection, waste management, etc. This document applies to the following: a) separate operation of wards dedicated to highly contagious respiratory infectious diseases; b) transportation of confirmed cases of highly contagious respiratory infectious diseases and roles of the dedicated healthcare team in a ward dedicated to highly contagious respiratory infectious diseases; c) cleaning, disinfection, and waste management.

  • Technical specification
    28 pages
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This document provides a collection of design considerations from existing international standards as well as best practices and observations obtained from the home healthcare field. This document is intended to be used as a reference for designing accessibility and usability of home healthcare products and associated services, and environments designed for non-professional users. This document does not provide information on the use of home healthcare products by healthcare professionals regardless of the place and facility of use.

  • Technical report
    25 pages
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This document specifies the infection prevention and control (IPC) measures for cross-border workers. It is applicable only in the circumstance of novel infectious disease outbreak while valid vaccine or drug for treatment are not available. It can be used for the purpose of maintaining economic activities when a country that workers need to enter blocks its border due to a pandemic or epidemic (Annex A). This document provides information on the key aspects and details of the process requirements, procedures for selecting service providers, such as travel management company, and procedures for cross-border workers amidst a pandemic, encompassing the complete set of stages from ‘pre-departure’, ‘border crossing’, ‘quarantine and commute’, to ‘return’, and is addressed to all stakeholders involved in travel, whether from the public or private sector. NOTE Stakeholders are comprised of but not limited to health authority, healthcare organization and screening stations, accommodation services, transportation services, travel agencies, and private companies including their contractors and providers.

  • Technical specification
    23 pages
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This document specifies requirements for the inner pack of decoction pieces of Chinese medicines, including packaging materials, physical properties, specifications and labels. This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision and management of inner pack of decoction pieces.

  • Standard
    8 pages
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This document specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems. This document covers facility readiness, hand hygiene education and training, monitoring, performance, promotion and identifying key issues that require attention for improvement. Procedures for surgical hand preparation are not addressed in this document. Furthermore, this document does not take into consideration, surface disinfection, instrument disinfection, ultraviolet irradiation (UV-C), heat sterilization, room fogging or electrostatic spraying devices and any other methods typically not designed or suitable for human hand hygiene purposes. Excluding surgical hand preparation, this document applies specifically to clinical healthcare workers, patients and visitors.

  • Standard
    33 pages
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The purpose of this document is to provide organizations with requirements to deliver high-quality healthcare and specifies requirements for management systems for quality in healthcare organizations when an organization desires to: a) demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements; b) enhance service user experience during the continuum of care and continually improve healthcare quality; and c) create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centred care. The requirements of this document are based on recognized best practices and are intended to be applicable to any organization providing healthcare services, regardless of its type, size, or the services it provides.

  • Standard
    35 pages
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IEC SRD 63416:2023 describes ethical considerations that are relevant when developing AAL systems and AAL services.
This document covers AAL-specific issues related to AI that supplement those ethical considerations already addressed in other AI documents. Examples include the WHO and OECD principles of AI and those of the High-Level Expert Group on Artificial Intelligence set up by the European Commission.
This document analyses whether these frameworks for the governance of AI are sufficient to meet the requirements of the AAL environment and in particular to meet the needs of AAL care recipients.
The objective of the ethical assessment is to create concrete and clear ethical guidelines that can be used as checklists in AAL service and system platform design, development and implementation.

  • Standardization document
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This document describes the requirements, operational principles, and procedures of the temporary medical facility (TMF) regarding: a) planning; b) staffing; c) patient management; d) discharge and termination of isolation for patients with infectious diseases in the context of ongoing widespread community transmission.

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    14 pages
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This CEN workshop agreement defines a harmonized CBRN training curriculum to be used and valued by training institutes for first responders in Europe. It considers practitioner’s needs and possess a modular structure that enables national organizations to build upon based on their own examples, procedures and experiences.
The planned CEN Workshop is intended to be used by first responders and medical staff in all EU Member States.

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  • Technical report
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This CEN workshop agreement defines a harmonized CBRN training curriculum to be used and valued by training institutes for first responders in Europe. It considers practitioner’s needs and possess a modular structure that enables national organizations to build upon based on their own examples, procedures and experiences.
The planned CEN Workshop is intended to be used by first responders and medical staff in all EU Member States.

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  • Technical report
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This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
—    management of telehealth quality processes by the healthcare organization;
—    strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
—    healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
—    management of financial resources to support telehealth services;
—    management of information management and security used in telehealth services;
—    processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

  • Standard
    57 pages
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This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
—    management of telehealth quality processes by the healthcare organization;
—    strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
—    healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
—    management of financial resources to support telehealth services;
—    management of information management and security used in telehealth services;
—    processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.

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    57 pages
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This document specifies the operation of a walk-through screening station (WTSS) for mass testing as part of pandemic response management. NOTE COVID-19 is an exemplary disease for which such a station is developed.

  • Standard
    15 pages
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IEC 60050-871:2018 gives the general terminology used in active assisted living, as well as general terms pertaining to specific applications and associated technologies. This terminology is consistent with the terminology developed in the other specialized parts of the IEV.
It has the status of a horizontal standard in accordance with IEC Guide 108.

  • Standard
    98 pages
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  • Standard
    84 pages
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This document aims to specify a categorial structure in the field of disorder representation in traditional Chinese medicine (TCM) by defining a set of domain constraints for use within terminological resources. It contains a concept detailing the domains of four subcategories: body parts, causative agents, pathological process and manifestation. This document does not include: — a comprehensive categorial structure for TCM; — a treatment procedure for TCM; — relevant devices; — terms or descriptions for subcategories of body parts, causative agents, pathological process or manifestation.

  • Technical specification
    7 pages
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This document specifies the operation of a drive-through screening station (DTSS) for mass testing as part of pandemic response management. NOTE COVID-19 is an exemplary disease for which such a station is developed.

  • Standard
    13 pages
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This document provides a framework for dementia-inclusive communities, including principles and the considerations of inclusion, quality of life, built environments, special needs groups, and stakeholder engagement. It also provides guidance on how to systematically leverage, improve, and interconnect their existing assets and structures and transform efficiently into a dementia-inclusive community. This document does not provide any clinical standards.

  • Standard
    41 pages
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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.

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    52 pages
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This document specifies requirements and provides guidelines for an organizational program for working carers providing care to:
—   adult care recipients (e.g. adults with cognitive, sensory, physical, and invisible disabilities, adults with chronic or episodic conditions and older dependents);
—   long-term childcare recipients (e.g. due to chronic illness or permanent cognitive, sensory or physical disability or injury).
This document is applicable to any organization, regardless of size, sector or community setting (i.e. urban, rural or remote).
This document can be used in conjunction with an organization’s management systems, human resource programs, and/or equity, diversity and inclusion programs, or on its own in the absence of a formal workplace program to support working carers.

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    29 pages
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  • Standard
    21 pages
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  • Standard
    21 pages
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  • Standard – translation
    27 pages
    Slovenian language
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This document provides requirements and recommendations for the rapid construction of emergency medical facilities, including various categories of public health emergencies, for handling large numbers of casualties and patients. The functional composition of emergency medical facilities is determined by the characteristics of the emergencies. This document is applicable to new projects built on new sites or within existing medical institutions, where emergency medical facilities are constructed rapidly from steel-frames and prefabricated standard plates or box structures.

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    14 pages
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  • Standardization document
    14 pages
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The services specified in this document are health and social care services for older persons provided by healthcare and social care personnel. This document
-   specifies requirements and recommendations for services provided to the older person at home and in care homes, based on the older person's individual needs and preferences to assist self-determination, participation, and a safe and secure old age.
-   specifies requirements and recommendations for systematic approaches regarding the service provider’s ability to produce a good quality of care and support for the older person.
-   covers services irrespective of the legal form of ownership and whether the service is publicly or privately funded.
-   is applicable to care providers, regardless of structure, organization, ownership, size or type of the care services provided.
-   can be used by the service provider at all management levels in the organization to plan, lead, implement, maintain, evaluate and improve the quality of the service.
-   can be used by the provider for internal audits or self-assessment and/or external parties for certification/accreditation to assess the provider’s ability to meet the older person´s needs and expectations.
-   can be used to provide basic information for procurement and education.
-   does not cover standardization of medical devices and clinical guidelines.

  • Technical specification
    63 pages
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The services specified in this document are health and social care services for older persons provided by healthcare and social care personnel. This document
-   specifies requirements and recommendations for services provided to the older person at home and in care homes, based on the older person's individual needs and preferences to assist self-determination, participation, and a safe and secure old age.
-   specifies requirements and recommendations for systematic approaches regarding the service provider’s ability to produce a good quality of care and support for the older person.
-   covers services irrespective of the legal form of ownership and whether the service is publicly or privately funded.
-   is applicable to care providers, regardless of structure, organization, ownership, size or type of the care services provided.
-   can be used by the service provider at all management levels in the organization to plan, lead, implement, maintain, evaluate and improve the quality of the service.
-   can be used by the provider for internal audits or self-assessment and/or external parties for certification/accreditation to assess the provider’s ability to meet the older person´s needs and expectations.
-   can be used to provide basic information for procurement and education.
-   does not cover standardization of medical devices and clinical guidelines.

  • Technical specification
    63 pages
    English language
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This document specifies requirements and provides guidelines for an organizational program for working carers providing care to: — adult care recipients (e.g. adults with cognitive, sensory, physical, and invisible disabilities, adults with chronic or episodic conditions and older dependents); — long-term childcare recipients (e.g. due to chronic illness or permanent cognitive, sensory or physical disability or injury). This document is applicable to any organization, regardless of size, sector or community setting (i.e. urban, rural or remote). This document can be used in conjunction with an organization’s management systems, human resource programs, and/or equity, diversity and inclusion programs, or on its own in the absence of a formal workplace program to support working carers.

  • Standard
    29 pages
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  • Standard
    21 pages
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  • Standard
    21 pages
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  • Standard – translation
    27 pages
    Slovenian language
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  • Amendment
    27 pages
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  • Amendment
    27 pages
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IEC 61340-6-1:2018 applies to facilities that provide healthcare including hospitals, care centres and clinics. This document provides technical requirements and recommendations for controlling electrostatic phenomena in healthcare facilities, which includes requirements for equipment, materials, and products used to control static electricity. The requirements of this document do not apply to medical electrical equipment specified in IEC 60601-1 and in vitro diagnostic (IVD) medical equipment specified in IEC 61010‑2‑101.

  • Standard
    27 pages
    English language
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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.

  • Standard
    52 pages
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This document provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organization.

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    9 pages
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  • Standard
    9 pages
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This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.

  • Standard
    24 pages
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  • Standard
    18 pages
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  • Standard
    18 pages
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  • Standard
    19 pages
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  • Standard
    19 pages
    French language
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This document specifies minimum requirements for patient involvement in health care services with the aim to create favourable structural conditions for person-centred care.
It is applicable for use before, during and after the actual care that is provided by the care personnel.
This document is also applicable for use on a strategic level for quality assurance and quality improvement, for procurement, educational and supervisory purposes and as a guiding document for research and development projects in the field of intervention and implementation of person-centred care.

  • Standard
    30 pages
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This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.

  • Standard
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  • Standard
    18 pages
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  • Standard
    18 pages
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  • Standard
    19 pages
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  • Standard
    19 pages
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This document contains the terms, definitions, notes to entry and examples corresponding to the frequently used concepts which apply to diagnostic and therapeutic nuclear medicine. It comprises the minimum essential information for each nuclear medicine concept represented by a single term. It provides the reader with the information required to approach this multidisciplinary speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate communication and promote common understanding.

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    18 pages
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  • Standard
    18 pages
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IEC 63240-1:2020 specifies the AAL reference architecture.
This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components.
This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).

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    13 pages
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IEC 63240-2:2020 specifies the AAL architecture model.
This document defines concepts and introduces terminology. IEC 63240-1 provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components. This document provides a framework to analyse use cases on a common view and terminology, which is a foundation for communication to discuss the interoperability of the components of the AAL system. This document allows for the mapping of defined AAL use cases and supports the identification of interoperability issues and gap analysis of the standards.
This document also identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).

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    19 pages
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This document specifies requirements for operational practices in care settings when a provider wishes to demonstrate its ability to consistently provide and improve healthcare education or training that meets the learning requirements of educational organizations. All the requirements in this document are intended to be applicable to any provider, regardless of its type, size or the healthcare services it offers.

  • Standard
    12 pages
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  • Standardization document
    12 pages
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This document defines terms used in healthcare organization management.

  • Standard
    11 pages
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  • Standard
    11 pages
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This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.

  • Standard
    51 pages
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  • Standard
    51 pages
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This document specifies the minimum requirements enabling patient involvement in health care services with the aim to create favourable structural conditions for person-centred care.
It is intended to be used before, during and after the actual care provided by care personnel and to be available for use by the patient who is the recipient of the care.
This document is also intended to be used on a strategic level for quality assurance and improvement, during procurement, education and supervision as well as to be used as a guiding document for research and development projects within intervention and implementation of person-centred care.

  • Standard
    30 pages
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IEC TS 63134:2020 identifies AAL scenarios and use cases based on real-world applications and requirements. The use cases provide a practical context for considerations of interoperability and standards based on user experience. Use cases provide a context for utilizing existing standards and identifying further standardization work. User requirements have also been identified.
This document also highlights potential areas for standardization in the AAL environment to ensure safety, security, privacy, ease of operation, performance and interoperability.
Lastly, this document is a contribution to the IEC use case management repository, the purpose of which is to collect, administer, maintain, and analyse use cases.

  • Technical specification
    113 pages
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  • Technical specification
    238 pages
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This document defines terms for the theory, technology and methods of Chinese Materia Medica processing. It is not applicable to Kampo medicine.

  • Standard
    24 pages
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  • Standard
    24 pages
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