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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      1 day
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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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      1 day
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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 contains the terms, definitions, notes to entry and examples corresponding to the frequently used concepts which apply to diagnostic and therapeutic nuclear medicine. It comprises the minimum essential information for each nuclear medicine concept represented by a single term. It provides the reader with the information required to approach this multidisciplinary speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate communication...view more

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

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.

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    • Standard
      12 pages
      English language
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    • Draft
      12 pages
      English language

This document defines terms used in healthcare organization management.

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    • Standard
      11 pages
      English language
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    • Draft
      11 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

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 supervis...
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    • Standard
      30 pages
      English language
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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, 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 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 hear...view more

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    • Standard
      43 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 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 lif...
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    • Standard
      52 pages
      English language
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This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combine...view more

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    • Guide
      26 pages
      English language

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 lif...
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    • Standard
      52 pages
      English language
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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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    • 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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    • Standard
      27 pages
      English language
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      1 day

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
      27 pages
      English language
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      1 day

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

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.

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    • Standard
      84 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
      English language
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CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear

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    • Corrigendum
      9 pages
      English language
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This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

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    • Technical report
      85 pages
      English language
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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
      37 pages
      English language
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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

The standard specifies requirements for a quality management system in a healthcare organization

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    • Standard
      83 pages
      English language
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      1 day

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

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    • Standard
      27 pages
      English language
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      1 day
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    • Standard – translation
      26 pages
      Slovenian language
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      1 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.

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    • Standard
      27 pages
      English language
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      1 day
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    • Standard – translation
      26 pages
      Slovenian language
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      1 day

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

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    • Standard
      29 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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    • Standard
      26 pages
      English language
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EN ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activiti...view more

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    • Standard
      68 pages
      English language
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    • Standard
      78 pages
      German language
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      1 day
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    • Standard – translation
      131 pages
      Slovenian and English language
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      1 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.

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    • Technical specification
      39 pages
      English language
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      1 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.

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    • Technical specification
      39 pages
      English language
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      1 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.

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    • Standard
      35 pages
      English language
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      1 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.

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    • Standard
      35 pages
      English language
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      1 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 in...view more

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    • Standard
      66 pages
      English language
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      1 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.

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    • Technical report
      37 pages
      English language
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      1 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.

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    • Technical report
      37 pages
      English language
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      1 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...
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    • Standard
      125 pages
      English and French language

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.

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    • Standard
      48 pages
      English language
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      1 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, reconstruct...
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    • Standard
      48 pages
      English language
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EN 16224+A1 specifies requirements and recommendations for healthcare services provided by chiropractors.

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    • Standard
      35 pages
      English language
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      1 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, digni...view more

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

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    • Standard
      35 pages
      English language
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      1 day