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.

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

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

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

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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.

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

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

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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.

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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.

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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.

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This part of IEC 61340 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 [1] 1 and in vitro diagnostic (IVD) medical equipment specified in
IEC 61010-2-101 [2].

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

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

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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.

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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.

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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.

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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.

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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.

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This part of ISO 9241 establishes guidelines for the reduction of photosensitive seizures, one of three major undesirable biomedical effects, induced by images presented on electronic visual displays. The guidelines address the conditions essentially produced by electronic visual image contents presented at home and in work environments, but not by electronic visual display. The guideline in the document is for the protection of the vulnerable section of the viewing population who are photosensitive, and who are therefore prone to seizures triggered by flickering lights and regular patterns, including certain types of repetitive images.

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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.

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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).

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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).

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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 1 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 lit (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 packaging has been tampered with.
NOTE 2 The principles in this European Standard can be applied in other countries and sectors, as appropriate.

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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.

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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.

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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.

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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.

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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.

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No scope available

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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.

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