11.020.99 - Other standards related to health care in general
ICS 11.020.99 Details
Other standards related to health care in general
Autres normes relatives a la santé en général
Drugi standardi v zvezi z zdravstvom na splošno
General Information
e-Library Subscription
Create subscription and get permanent access to documents within 11.020.99 - Other standards related to health care in general
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
The particular requirements of this part of IEC 60364 apply to electrical installations in
medical locations so as to provide safety of patients and medical staff. These requirements
refer to:
- hospitals and clinics or equivalent institutions (including equivalent transportable and
mobile locations);
which, subject to assessment (710.30), can also include:
- sanatoriums and health clinics;
- dedicated locations in homes for senior citizens and aged care homes, where patients
receive medical care;
- medical centres, outpatients' clinics and departments, casualty wards;
- other outpatients' institutions (industrial, sports and others);
- medical and dental practices;
- dedicated medical rooms in the workplace;
- other locations where medical electrical equipment is used;
- veterinary clinics;
- rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
NOTE 1 Medical ME equipment and ME systems are covered by IEC 60601 (all parts).
NOTE 2 In the USA, the requirements of NFPA 70®, National Electrical Code® in general and specifically article
517 (Healthcare Facilities) apply.
- Standardization document41 pagesEnglish languagesale 10% offe-Library read for1 day
This prAA represents common modifications to prHD 60364-7-710
2019-11-29: no xml because common mod
- Amendment21 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment9 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 63240-1:2024 specifies the AAL reference architecture. This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components. This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience) and sets up a process to identify the needs on the body area network (BAN), edge and cloud computing in the architecture perspective.
IEC 63240-1:2024 cancels and replaces the first edition published in 2020. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) clarifying the Introduction;
b) new terms and definitions have been added in 3.1;
c) adaption of terms according to the IEV in the whole document;
d) reference to ethical considerations of AI when applied in the AAL context has been added in Clause 5;
e) clarifying the description of AAL reference architecture in 6.3.1;
f) process to identify the needs on BAN, edge and cloud computing in the architecture perspective has been added in 6.3.2 and 6.3.3;
g) new figures have been added in 6.3.2 and 6.3.3;
h) reference to standards inventory has been added in 7.1;
i) clarification of 7.5;
j) Annex A has been added;
k) updated bibliography.
- Standard24 pagesEnglish languagesale 15% off
IEC SRD 63408:2024 supports the experts in identifying hazards when developing and revising standards, specifications, and similar publications that deal with products and services for adult AAL care recipients. This document aims to address potential sources of bodily harm to adult AAL care recipients from products they use or are likely to contact, even if not explicitly intended for adult AAL care recipients.
This document provides valuable information for stakeholders in the absence of a specific standard.
Stakeholders can include auditors, safety inspectors, product designers, architects, interior home designers, installers, etc.
- Standardization document16 pagesEnglish languagesale 15% off
- Standard12 pagesEnglish and French languagesale 15% off
IEC 61340-6-1:2018 applies to facilities that provide healthcare including hospitals, care centres and clinics. This document provides technical requirements and recommendations for controlling electrostatic phenomena in healthcare facilities, which includes requirements for equipment, materials, and products used to control static electricity. The requirements of this document do not apply to medical electrical equipment specified in IEC 60601-1 and in vitro diagnostic (IVD) medical equipment specified in IEC 61010‑2‑101.
- Standard46 pagesEnglish languagesale 15% off
- Standard45 pagesEnglish and French languagesale 15% off
IEC SRD 63314:2024 provides guidance on the vocational education, training, and required competencies for persons working in the AAL field. For the purposes of this document persons working in the AAL field are referred to as AAL working persons.
The AAL technical assistant, AAL consultant, AAL technical expert, and AAL formal carer are considered as AAL working persons.
For the AAL informal carer, this document can be a reference when their training and education are developed and/or evaluated.
- Standardization document18 pagesEnglish languagesale 15% off
This document specifies requirements for the inner pack of decoction pieces of Chinese medicines, including packaging materials, physical properties, specifications and labels. This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision and management of inner pack of decoction pieces.
- Standard8 pagesEnglish languagesale 15% off
This CEN workshop agreement defines a harmonized CBRN training curriculum to be used and valued by training institutes for first responders in Europe. It considers practitioner’s needs and possess a modular structure that enables national organizations to build upon based on their own examples, procedures and experiences.
The planned CEN Workshop is intended to be used by first responders and medical staff in all EU Member States.
- Standardization document13 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical report13 pagesEnglish languagesale 10% offe-Library read for1 day
This CEN workshop agreement defines a harmonized CBRN training curriculum to be used and valued by training institutes for first responders in Europe. It considers practitioner’s needs and possess a modular structure that enables national organizations to build upon based on their own examples, procedures and experiences.
The planned CEN Workshop is intended to be used by first responders and medical staff in all EU Member States.
- Standardization document13 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical report13 pagesEnglish languagesale 10% offe-Library read for1 day
IEC TS 63134:2020 identifies AAL scenarios and use cases based on real-world applications and requirements. The use cases provide a practical context for considerations of interoperability and standards based on user experience. Use cases provide a context for utilizing existing standards and identifying further standardization work. User requirements have also been identified.
This document also highlights potential areas for standardization in the AAL environment to ensure safety, security, privacy, ease of operation, performance and interoperability.
Lastly, this document is a contribution to the IEC use case management repository, the purpose of which is to collect, administer, maintain, and analyse use cases.
- Technical specification113 pagesEnglish languagesale 15% off
- Technical specification238 pagesEnglish languagesale 15% off
- Technical specification9 pagesEnglish languagesale 15% off
This document aims to specify a categorial structure in the field of disorder representation in traditional Chinese medicine (TCM) by defining a set of domain constraints for use within terminological resources. It contains a concept detailing the domains of four subcategories: body parts, causative agents, pathological process and manifestation. This document does not include: — a comprehensive categorial structure for TCM; — a treatment procedure for TCM; — relevant devices; — terms or descriptions for subcategories of body parts, causative agents, pathological process or manifestation.
- Technical specification7 pagesEnglish languagesale 15% off
This document provides requirements and recommendations for the rapid construction of emergency medical facilities, including various categories of public health emergencies, for handling large numbers of casualties and patients. The functional composition of emergency medical facilities is determined by the characteristics of the emergencies. This document is applicable to new projects built on new sites or within existing medical institutions, where emergency medical facilities are constructed rapidly from steel-frames and prefabricated standard plates or box structures.
- Standard14 pagesEnglish languagesale 15% off
- Standardization document14 pagesEnglish languagesale 15% off
IEC 61340-6-1:2018 applies to facilities that provide healthcare including hospitals, care centres and clinics. This document provides technical requirements and recommendations for controlling electrostatic phenomena in healthcare facilities, which includes requirements for equipment, materials, and products used to control static electricity. The requirements of this document do not apply to medical electrical equipment specified in IEC 60601-1 and in vitro diagnostic (IVD) medical equipment specified in IEC 61010‑2‑101.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard18 pagesEnglish languagesale 15% off
- Standard19 pagesFrench languagesale 15% off
This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard18 pagesEnglish languagesale 15% off
- Standard19 pagesFrench languagesale 15% off
IEC 63240-1:2020 specifies the AAL reference architecture.
This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components.
This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).
- Standard13 pagesEnglish languagesale 15% off
IEC 63240-2:2020 specifies the AAL architecture model.
This document defines concepts and introduces terminology. IEC 63240-1 provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components. This document provides a framework to analyse use cases on a common view and terminology, which is a foundation for communication to discuss the interoperability of the components of the AAL system. This document allows for the mapping of defined AAL use cases and supports the identification of interoperability issues and gap analysis of the standards.
This document also identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).
- Standard19 pagesEnglish languagesale 15% off
This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.
- Standard51 pagesEnglish languagesale 15% off
This document defines terms for the theory, technology and methods of Chinese Materia Medica processing. It is not applicable to Kampo medicine.
- Standard24 pagesEnglish languagesale 15% off
This document specifies an information model within the field of Chinese materia medica processing. It defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and an applicable information model. This model aims at representing the concepts applicable to Chinese materia medica processing in the making of decoction pieces. This document is not applicable to Japanese traditional Kampo medicine.
- Technical specification11 pagesEnglish languagesale 15% off
This document establishes the core classification framework for the integration of clinical terms from traditional Chinese medicine (TCM) and Western medicine. This structure supports terminology integration in standardized electronic medical records, including professional clinical terms in TCM and Western medicine. Non-technical terms for electronic medical records are also included.
- Technical specification8 pagesEnglish languagesale 15% off
This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.
- Standard9 pagesEnglish languagesale 15% off
IEC 61340-6-1:2018 applies to facilities that provide healthcare including hospitals, care centres and clinics. This document provides technical requirements and recommendations for controlling electrostatic phenomena in healthcare facilities, which includes requirements for equipment, materials, and products used to control static electricity. The requirements of this document do not apply to medical electrical equipment specified in IEC 60601-1 and in vitro diagnostic (IVD) medical equipment specified in IEC 61010‑2‑101.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This Technical Specification provides guidance for managing security of (high risk) chemical, biological, radioactive, nuclear or Explosive materials, such as those covered by the EU CBRN action plan, that are used within healthcare facilities (HCF); it covers the lifecycle of such materials within a HCF’s span of control. In this Technical Specification these materials are referred to as ‘CBRNE materials’.
It covers the protection of (high risk) CBRNE materials used in healthcare facilities against security threats relating to their deliberate misuse. It covers the protection of people, assets and information related to CBRNE materials.
This Technical Specification also applies to circumstances where healthcare is provided at locations remote from the normal location of the HCF.
This Technical Specification also provides guidance to all stakeholders that are responsible for each step in a lifecycle of CBRNE materials within the HCF such as such as administrator staff, facility management staff, logistics and transport staff, medical staff, waste management staff, domestic staff and security staff as well as visitors and contractors working on the HCF premises.
This Technical Specification can be applied as part of generic management systems such as EN ISO 9001 [2], EN ISO 22301 [3], ISO 22320 [4] and possibly ISO 28001 [5].
It does not apply to occupational health and safety issues deriving from the proper and improper use of such materials.
- Technical specification37 pagesEnglish languagesale 10% offe-Library read for1 day
This Technical Specification provides guidance for managing security of (high risk) chemical, biological, radioactive, nuclear or Explosive materials, such as those covered by the EU CBRN action plan, that are used within healthcare facilities (HCF); it covers the lifecycle of such materials within a HCF’s span of control. In this Technical Specification these materials are referred to as ‘CBRNE materials’.
It covers the protection of (high risk) CBRNE materials used in healthcare facilities against security threats relating to their deliberate misuse. It covers the protection of people, assets and information related to CBRNE materials.
This Technical Specification also applies to circumstances where healthcare is provided at locations remote from the normal location of the HCF.
This Technical Specification also provides guidance to all stakeholders that are responsible for each step in a lifecycle of CBRNE materials within the HCF such as such as administrator staff, facility management staff, logistics and transport staff, medical staff, waste management staff, domestic staff and security staff as well as visitors and contractors working on the HCF premises.
This Technical Specification can be applied as part of generic management systems such as EN ISO 9001 [2], EN ISO 22301 [3], ISO 22320 [4] and possibly ISO 28001 [5].
It does not apply to occupational health and safety issues deriving from the proper and improper use of such materials.
- Technical specification37 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 18662-1:2017 specifies the basic vocabulary for the Chinese Materia Medica (CMM), including most commonly used CMM species. Each term is provided a Latin name, Chinese name, Pinyin name and English name. Source-related definition of applicable parts and botanical name(s) of the plant, zoological family name of the animal, or mineral stated with mineral or rock title and active ingredients are given as note(s) for each item. ISO 18662-1:2017 is intended to be used by those engaged in the practice and management of production, trade, research and education of crude natural Chinese medicinal materials.
- Standard143 pagesEnglish languagesale 15% off
1.1 This practice outlines the irradiator installation qualifi-cation program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation process-ing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range. 1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and 60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy. 1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV. 1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539). 1.5 ISO 51939:2017 is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628. 1.6 ISO 51939:2017 does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro-priate safety and health practices and to determine the applicability or regulatory limitations prior to use.
- Standard13 pagesEnglish languagesale 15% off
ISO 19465:2017 specifies a categorial structure within the subject field of traditional Chinese medicine (TCM) clinical practice. It describes the upper-level categories of TCM clinical terms and the nomenclature of the hierarchical categories. It is applicable only to clinical terminological systems in TCM disciplines, not to a comprehensive categorial structure of TCM, the conceptual definition of the hierarchy categories, and terms for individual TCM concepts. The following are considered outside the scope of this document: - comprehensive categories of TCM; - the conceptual definition of the hierarchy categories. - terms for individual TCM concepts; - the terms or categories of Kampo, Korean medicine and other traditional medicines.
- Standard8 pagesEnglish languagesale 15% off
ISO 9241-391:2016 provides requirements and recommendations for reducing photosensitive seizures (PSS), while viewing images on electronic displays.
The requirements and recommendations in this part of ISO 9241 are designed to be applied to image contents. By image contents, reference is made to the images independent of the device or environment in which they are displayed.
The requirements and recommendations in this part of ISO 9241 are for the protection of the vulnerable individuals in the viewing population who are photosensitive and who are therefore liable to seizures triggered by flashing lights and regular patterns, including certain repetitive images.
NOTE 1 ITU considers the image safety issues in relation to broadcasting. Some of these are described in ITU-R BT.1702.[2]
NOTE 2 There are some related recommendations in ISO/IEC 40500:2012, W3C Web Content Accessibility Guidelines (WCAG) 2.0, for web contents accessibility.
NOTE 3 Photosensitive seizures and photosensitive epilepsy, that is, chronic conditions characterized by those repeated seizures are medical conditions. Clinical aspects of photosensitivity appear in Annex C. Visually induced seizures are equivalent to PSS.
- Standard26 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
The particular requirements of this part of HD 60364 apply to electrical installations in medical locations so as to ensure safety of patients and medical staff. These requirements, in the main, refer to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place.
The requirements of this part do not apply to ME equipment. This part also applies to electrical installations in locations designed for medical research.
NOTE 1 It may be necessary to modify the existing electrical installation, in accordance with this standard, when a change of utilization of the location occurs. Special care should be taken where intracardiac procedures are performed in existing installations.
NOTE 2 Where applicable, this standard can also be used in veterinary clinics.
NOTE 3 For ME equipment and ME systems, refer to the EN 60601 series.
NOTE 4 Care should be taken that other installations should not impair the installations.
NOTE 5 These requirements concern, for example, electrical installations for medical locations in:
− hospitals and clinics (including container design);
− sanatoriums and health clinics;
− dedicated locations in homes for senior citizens and aged care, where the patients are subjected to medical care;
− medical centres, outpatients’ clinics and departments, casualty wards;
− other outpatients’ institutions (industrial, sports and others).
- Corrigendum1 pageEnglish languagesale 10% offe-Library read for1 day
The particular requirements of this part of HD 60364 apply to electrical installations in medical locations so as to ensure safety of patients and medical staff. These requirements, in the main, refer to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place.
The requirements of this part do not apply to ME equipment. This part also applies to electrical installations in locations designed for medical research.
NOTE 1 It may be necessary to modify the existing electrical installation, in accordance with this standard, when a change of utilization of the location occurs. Special care should be taken where intracardiac procedures are performed in existing installations.
NOTE 2 Where applicable, this standard can also be used in veterinary clinics.
NOTE 3 For ME equipment and ME systems, refer to the EN 60601 series.
NOTE 4 Care should be taken that other installations should not impair the installations.
NOTE 5 These requirements concern, for example, electrical installations for medical locations in:
− hospitals and clinics (including container design);
− sanatoriums and health clinics;
− dedicated locations in homes for senior citizens and aged care, where the patients are subjected to medical care;
− medical centres, outpatients’ clinics and departments, casualty wards;
− other outpatients’ institutions (industrial, sports and others).
- Standardization document46 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 This European Prestandard specifies general administrative messages for electronic information exchange between healthcare information systems. 1.2 The messages defined in this European Prestandard provide for an identification framwork for both administrative and non-administrative purposes.1.3 The messages identified in this European Prestandard pay especial attention to identification of both the individual and records pertaining to them and the registration of the individual on healthcare information systems.
- Standardization document162 pagesEnglish languagesale 10% offe-Library read for1 day
No scope available
- Technical report65 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
NOTE The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. Article 54(o) of the Directive stipulates, that on the outer packaging of certain medicinal products or, where there is no outer packaging, on the immediate packaging shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with".
The principles in this European Standard can be applied in other countries and sectors, as appropriate.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
The particular requirements of this part of IEC 60364 apply to electrical installations in medical locations so as to ensure safety of patients and medical staff. These requirements, in the main, refer to hospitals, private clinics, medical and dental practices, health care centres and dedicated medical rooms in the work place. NOTE 1 It may be necessary to modify the existing electrical installation, in accordance with this standard, when a change of utilization of the location occurs. Special care should be taken where intracardiac procedures are performed in existing installations. NOTE 2 Where applicable this standard can also be used in veterinary clinics. The requirements of this part do not apply to medical electrical equipment. NOTE 3 For medical electrical equipment, refer to the IEC 60601 series.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/ASTM 51939:2013 outlines irradiator installation qualification, operational qualification, performance qualification and routine product processing dosimetric procedures to be followed in the irradiation of blood and blood components by the blood-banking community. If followed, these procedures will help to ensure that the products processed with ionizing radiation from gamma, X-radiation (bremsstrahlung), or electron sources receive absorbed doses within a predetermined range. ISO/ASTM 51939:2013 covers dosimetry for the irradiation of blood for these types of irradiators: self-contained irradiators (free-standing irradiators) utilizing 137Cs, 60Co or X-radiation (bremsstrahlung), teletherapy units, and electron accelerators. ISO/ASTM 51939:2013 also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated.
- Standard13 pagesEnglish languagesale 15% off
The standard specifies the transport profiles (OSI layers) for medical image interchange applications, on LAN, WAN, and public networks. The profiles cover requirements of pluridisciplinary medical image interchange, including applications in radiology, nuclear medicine, pathology, internal medicine, dermatology, ophthalmology etc., dealing with different types (static, 3D, Video,...) of images. The standard shall also define the interface between the profiles and the medical image management standard.
- Technical report116 pagesEnglish languagesale 10% offe-Library read for1 day
This Report lists terms, definitions and codes for medical devices; the listing is structured such that it can be used for the purpose of regulatory data exchange.
- Amendment8 pagesEnglish languagesale 10% offe-Library read for1 day
This Report lists terms, definitions and codes for medical devices; the listing is structured such that it can be used for the purpose of regulatory data exchange.
- Standardization document789 pagesEnglish languagesale 10% offe-Library read for1 day
Intended to help minimize the risk of an airway fire when using a laser. Represents current knowledge at the time of publication and is subject to review. Does not address management of the patient with a tracheotomy. Also intended to assist related groups, such as laser safety committees.
- Technical report10 pagesEnglish languagesale 15% off