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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    • Standard
      24 pages
      English language
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    • Standard
      18 pages
      English language
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    • Standard
      19 pages
      French language
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    • Draft
      18 pages
      English language
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    • Draft
      19 pages
      French language

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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    • Standard
      24 pages
      English language
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    • Standard
      18 pages
      English language
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    • Standard
      19 pages
      French language
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    • Draft
      18 pages
      English language
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    • Draft
      19 pages
      French language

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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    • Standard
      13 pages
      English language

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 allow...
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      19 pages
      English language

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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    • Standard
      51 pages
      English language
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    • Draft
      51 pages
      English language

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, p...
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    • Technical specification
      113 pages
      English language

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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    • Standard
      24 pages
      English language

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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    • Technical specification
      11 pages
      English language

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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    • Technical specification
      8 pages
      English language

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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    • Standard
      9 pages
      English language

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) med...
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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 s...view more

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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 s...view more

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    • Standard
      45 pages
      English and French language

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 ag...
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    • Technical specification
      37 pages
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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 ag...
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    • Technical specification
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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 prac...view more

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    • Standard
      143 pages
      English language

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 pr...view more

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    • Standard
      13 pages
      English language

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 out...view more

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    • Standard
      8 pages
      English language

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 photosensi...view more

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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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      39 pages
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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 ...
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    • Corrigendum
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      English language
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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 ...
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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 m...
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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 ...view more

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    • Standard
      20 pages
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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 5193...view more

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    • Standard
      13 pages
      English language

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 st...view more

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    • Technical report
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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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      789 pages
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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 healthcar...view more

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    • Standardization document
      162 pages
      English language
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No scope available

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    • Technical report
      65 pages
      English language
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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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    • Technical report
      10 pages
      English language