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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  • Draft
    12 pages
    English language
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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
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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
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
-   treatments with resorbable injectables, botulinum toxin and micro needling;
-   treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
-   treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
-   other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

  • Standard
    52 pages
    English language
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
-   treatments with resorbable injectables, botulinum toxin and micro needling;
-   treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
-   treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
-   other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

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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
    84 pages
    English and French language
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This European Standard specifies requirements for a quality management system when a healthcare organization:
a)   needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and
b)   aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
NOTE 1   Statutory and regulatory requirements can be expressed as legal requirements.
Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of this standard as they are regulated elsewhere.
This standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this standard where applicable.
This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

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This European Standard specifies the minimum requirements for medical doctors with additional qualification in homoeopathy and their services.
This European Standard is not applicable to services provided by persons not being medical doctors or to the preparation of homoeopathic medicines.

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    26 pages
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This European Standard specifies the minimum requirements for medical doctors with additional qualification in homeopathy and their services.
This European Standard is not applicable to services provided by persons not being medical doctors, nor to the preparation of homeopathic medicines, nor to the methodology and practice of homeopathic provings.

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IWA 18:2016 provides guidelines for addressing challenges faced by societies that have been unable to adapt to an ageing population. It can also be used by stakeholders as a useful reference at regional or global level. IWA 18:2016 addresses health, care and social challenges (including health care needs, daily living tasks, well-being, combating isolation and keeping safe) to ensure that the needs of individuals continue to be met as they grow older. It also outlines principles related to ethics, community-based solutions, integration, person-centred solutions and innovation.

  • Standard
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The standard will specify requirements for planning, establishing, implementing, operating, monitoring, reviewing, maintaining and continually improving a documented security management system in healthcare facilities.

  • Technical specification
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This European Standard specifies the requirements and recommendations regarding the healthcare provision, facilities and equipment, education, and ethical framework for good practice of osteopathy.

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This European Standard specifies the requirements and recommendations regarding the healthcare provision, facilities and equipment, education, and ethical framework for the good practice of osteopathy.

  • Standard
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NEW! IEC 60601-1-11:2015 is available as IEC Standards+ 60601-1-11:2015 which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-1-11:201 5 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.

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This Technical Report specifies recommendations for the care of babies born with cleft lip and/or cleft palate at time of diagnosis (ante- and/or postnatal) and the year following birth or diagnosis (whichever is later), including referral processes, establishment of feeding, parental support and care pathways.
Recommendations on all aspects of surgery, including timing and the use of pre surgical orthopaedics is excluded.

  • Technical report
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This Technical Report specifies recommendations for the care of babies born with cleft lip and/or cleft palate at time of diagnosis (ante- and/or postnatal) and the year following birth or diagnosis (whichever is later), including referral processes, establishment of feeding, parental support and care pathways.
Recommendations on all aspects of surgery, including timing and the use of pre surgical orthopaedics is excluded.

  • Technical report
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IEC 60601-1-11:2015 is available as IEC 60601-1-11:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and
- harmonizing with the changes to the amendments to the general standard and other collateral standards.

  • Standard
    125 pages
    English and French language
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This European Standard specifies the requirements and provides recommendations of aesthetic surgery services to patients, including the ethical framework and general principles according to which these services – before, during and after the intervention - are provided by all facilities.

  • Standard
    48 pages
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This European Standard addresses the requirements for clinical aesthetic practice: This covers surgical services to patients who want to change their physical appearance.
This European Standard provides recommendations for procedures for clinical treatment, including the ethical framework and general principles according to which clinical services are provided by all aesthetic practitioners. These recommendations apply before, during and after the procedure.
Dentistry ) procedures, reconstructive surgery procedures and aesthetic non-surgical medical procedures are excluded from the scope of this European Standard.
Aesthetic non-medical procedures (e.g. tattoos, piercing) which can be legally performed by non-physicians (e.g. beauty therapists, hairdressers) are excluded from the scope of this European Standard.

  • Standard
    48 pages
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EN 16224+A1 specifies requirements and recommendations for healthcare services provided by chiropractors.

  • Standard
    35 pages
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This Technical Report provides guidance for assessing the problems and risks associated with manual patient handling in the healthcare sector, and for identifying and applying ergonomic strategies and solutions to those problems and risks. Its main goals are - to improve caregivers' working conditions by decreasing biomechanical overload risk, thus limiting work-related illness and injury, as well as the consequent costs and absenteeism, and - to account for patients' care quality, safety, dignity and privacy as regards their needs, including specific personal care and hygiene. It is intended for all users (or caregivers and workers) involved in healthcare manual handling and, in particular, healthcare managers and workers, occupational safety and health caregivers, producers of assistive devices and equipment, education and training supervisors, and designers of healthcare facilities. Its recommendations are primarily applicable to the movement of people (adults and children) in the provision of healthcare services in purposely built or adapted buildings and environments. Some recommendations can also be applied to wider areas (e.g. home care, emergency care, voluntary caregivers, cadaver handling). The recommendations for patient handling take into consideration work organization, type and number of patients to be handled, aids, spaces where patients are handled, as well as caregivers' education and awkward postures, but do not apply to object (movement, transfer, pushing and pulling) or animal handling. Task joint analysis in a daily shift involving patient handling, pulling and pushing or object handling and transport is not considered.

  • Technical report
    99 pages
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This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.

  • Standard
    35 pages
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This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties and the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
This Technical Report provides assistance on how the EN ISO 9004:2000 guidelines may be applied to health services, without prescribing the activities that need to be done by the health service provider; the latter should use its own professional knowledge and/or follow guidelines and protocols established by relevant professional bodies.
Even though EN ISO 9004:2000 promotes a better understanding of the EN ISO 9001:2000 requirements, its scope goes further than that. It is a technical document for managers and process owners to monitor and improve organisation performance, minimise risks, reduce costs, satisfy customers and improve competitiveness.
To fulfil the requirements of processes that have impact on patient safety this Technical Report provides an approach for improvement of risk management in the organisation.
An important value of EN ISO 9004:2000 is that it can be used for self-assessment (see Annex A) comparing the performance of the organisation with the 290 in

  • Technical report
    91 pages
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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
    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.

  • Draft
    49 pages
    English language
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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.

  • Draft
    63 pages
    English language
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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.

  • Draft
    63 pages
    English language
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    e-Library read for
    1 day

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.

  • Draft
    49 pages
    English language
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
-   treatments with resorbable injectables, botulinum toxin and micro needling;
-   treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
-   treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
-   other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

  • Standard
    52 pages
    English language
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
-   treatments with resorbable injectables, botulinum toxin and micro needling;
-   treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
-   treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
-   other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

  • Standard
    52 pages
    English language
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    1 day

This European Standard addresses the requirements for aesthetic medicine services to patients.
This European Standard provides recommendations for non-surgical medical procedures for clinical treatment, including the ethical framework and general principles according to which clinical services are provided by all aesthetic practitioners. These recommendations apply before, during and after the procedure.
Dentistry ) procedures and aesthetic surgical procedures covered by EN 16372 are excluded from the scope of this European Standard.
Aesthetic non-medical procedures (tattooing and any procedure not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

  • Standard
    50 pages
    English language
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  • Draft
    47 pages
    English language
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
-   treatments with resorbable injectables, botulinum toxin and micro needling;
-   treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
-   treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
-   other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

  • Standard
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    47 pages
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1.1   General
This European standard specifies requirements for a quality management system where an organization:
a)   needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards
b)   aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics ; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical and psychological integrity; patient involvement; patient safety and timelines/accessibility.
Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere.
This European Standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this European Standard where applicable.
This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients.
The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.
1.2   Application
This European Standard
a)    gives requirements for systematic approaches for the organization’s ability to produce good quality health care.
b)    can be used by management at all levels in the health care organization to implement and maintain a quality management system or by internal and external parties, including certification bodies, to assess the organization’s ability to meet patients’ needs and expectations as well those from other customers.
c)    is applicable to health care organizations, regardless of structure, organization, owner, size or type of health care services provided.
d)   is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies.
e)   is focused on requirements for clinical processes. Organizations that also include research or education processes, in the scope of their quality management system could use the requirements in this standard where applicable.
Where any requirement(s) of this European Standard cannot be applied due to the nature of a health care organization and its product (including services), this can be considered for exclusion.
Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the health care organization’s ability, or responsibility, to provide products (including services) that meets customer and applicable statutory and regulatory requirements.

  • Standard
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  • Standard – translation
    94 pages
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This standard specifies requirements and recommendations for health care services provided by chiropractors.

  • Standard
    30 pages
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This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.

  • Standard
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A quality management system is a management system to direct and control an organisation with regard to quality (ISO 9000:2000).
The guide is generally applicable to the health services sector and will complement national legislation. Furthermore other national requirements, sector specific requirements and standards may complement the guide or be used in parallel.
The main target groups for this guide are strategic decision-makers at all levels in the health services sector and all staff who are involved in the development, implementation and assessment of a quality management system in a health care organisation, including the stakeholders.  
This guide is generally applicable to all health care organisations regardless of structure, organisation, owner, size, type of service provided, locally used approaches or location.  When using and adapting this guide every organisation needs to consider the nature, culture, complexity, legislation, regulation, etc. of their organisation and further specify their own requirements and use complementary national and local information.  
The guide also applies to the requirements of patient organisations, owners, users, insurers, inspectorates and to relevant legislation.  In this manner the guide provides a basis for national requirements on health services, e.g. Provisions and Recommendations, for purchasers of health services, for contracts and agreements, and for supervision, audit, certification and accreditation in the health services sector.

  • Technical specification
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1.1   The scope of the messages specified by this document comprises healthcare service requests and reports related to laboratory and diagnostic investigations [3.28] as well as specialist services [3.35] carried out by healthcare service providers on subjects of care [3.51]. They cover electronic information exchange between computer systems used by healthcare parties requesting the services of, healthcare service providers.
1.2   This document is applicable to messages requesting healthcare services or reporting results of healthcare services independent of medical specialty. The messages can be used for:
-   laboratory services, such as clinical biochemistry, clinical microbiology and haematology;
-   diagnostic services, such as radiology, anatomical pathology and nuclear medicine;
-   specialist services, such as referral and discharge messages.
1.3   This document does not specify the manner in which healthcare services are divided between specialties as this varies in accordance with national and local practices.
1.4   This document is applicable to requests for new investigation or specialist service and also modifications of previously issued requests.
1.5   It is applicable both to the subject of investigation as well as samples that are obtained from subjects of investigation at the point of care or at any other location and submitted to the healthcare services, and to requests for investigation for which the healthcare service is requested to obtain samples. The subject of investigation can be a person, an animal, a group of animals or a material.
1.6   The messages support standing orders for healthcare services.
1.7   This document is applicable to new reports and modifications of previously issued reports.
1.8   The messages it specifies support the communication of partial, supplementary, complete and cumulative reports. Reporting modes which may be implemented using this document include:
-   sending a requested healthcare service report only when all results a

  • Standard
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IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

  • Standard
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This European Prestandard specifies general messages to enable electronic exchange of requests for, and reports of diagnostic services. The information exchanges covered are those between computer systems used by diagnostic service departments and computer systems used by healthcare parties requesting, or receiving results of, diagnostic services.  Within limits identified by subsequent clauses of this scope statement, this E. Prestandard is applicable to messages requesting, or reporting on the resultsof the following diagnostic services:*Radiology*Nuclear medicine*Ultrasound*...

  • Standardization document
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This European Prestandard specifies general messages for electronic information exchange between computer systems used by healthcare parties requesting specia- list services or receiving reports from specialist service departments. Examples of requests for healthcare speciality services include:-referral of a patient from a GP to a hospital clinial specialist;-referral of a patient for direct entry for an open access procedure;-referral of a patient for direct entry onto an operation waiting list;-referral of a p. for emergency hospital admission (acute referral);-r. of a p. for treatment by a paramedical specialist

  • Standardization document
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This European Prestandard specifies general messages for electronic information exchange between clinical laboratories' computer systems and computer systems used by healthcare parties requesting the services of, or receiving results from, clinical laboratories (abbreviated as laboratories in this Prestandard).

  • Standardization document
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