11.020.10 - Health care services in general
ICS 11.020.10 Details
Health care services in general
Prestation de soins de santé en général
Zdravstvene storitve na splošno
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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 document15 pagesEnglish languagesale 15% off
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.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard12 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document provides guidance for the daily activities to practice social distancing and source control as pre-emptive actions to prevent infectious disease.
- Standard11 pagesEnglish languagesale 15% off
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 document21 pagesEnglish languagesale 15% off
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 report25 pagesEnglish languagesale 15% off
- Standard45 pagesEnglish and French languagesale 15% off
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 document25 pagesEnglish languagesale 15% off
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.
- Standard14 pagesEnglish languagesale 15% off
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.
- Standard98 pagesEnglish and French languagesale 10% offe-Library read for1 day
- Standard84 pagesEnglish and French languagesale 15% off
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.
- Standard41 pagesEnglish languagesale 15% off
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
- Standard – translation27 pagesSlovenian languagesale 10% offe-Library read for1 day
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 specification63 pagesEnglish languagesale 10% offe-Library read for1 day
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 specification63 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
- Standard – translation27 pagesSlovenian languagesale 10% offe-Library read for1 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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/295
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard12 pagesEnglish languagesale 15% off
- Standardization document12 pagesEnglish languagesale 15% off
- Standard16 pagesEnglish and French languagesale 15% off
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.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard43 pagesEnglish languagesale 15% off
- Standard43 pagesEnglish languagesale 15% off
- Standard47 pagesFrench languagesale 15% off
- Standard47 pagesFrench languagesale 15% off
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard66 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard98 pagesEnglish and French languagesale 10% offe-Library read for1 day
- Standard84 pagesEnglish and French languagesale 15% off
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.
- Standard83 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation127 pagesSlovenian and English languagesale 10% offe-Library read for1 day
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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation26 pagesSlovenian languagesale 10% offe-Library read for1 day
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.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation26 pagesSlovenian languagesale 10% offe-Library read for1 day
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.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
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 specification39 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies the requirements and recommendations regarding the healthcare provision, facilities and equipment, education, and ethical framework for good practice of osteopathy.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard48 pagesEnglish languagesale 10% offe-Library read for1 day
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 report37 pagesEnglish languagesale 10% offe-Library read for1 day
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 report37 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard190 pagesEnglish languagesale 15% off
- Standard125 pagesEnglish and French languagesale 15% off
- Standard257 pagesEnglish and French languagesale 15% off
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.
- Standard48 pagesEnglish languagesale 10% offe-Library read for1 day
EN 16224+A1 specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
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 report99 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard10 pagesEnglish and French languagesale 15% off
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. The contents of the corrigendum of April 2011 have been included in this copy.
- Standard117 pagesEnglish and French languagesale 15% off
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 report91 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation94 pagesSlovenian and English languagesale 10% offe-Library read for1 day