11.020 - Medical sciences and health care facilities in general
ICS 11.020 Details
Medical sciences and health care facilities in general
Medizinische Wissenschaften im allgemeinen
Sciences médicales et équipement de soins médicaux en général
Medicinske vede in zdravstvenovarstveni pripomočki na splošno
General Information
Frequently Asked Questions
ICS 11.020 is a classification code in the International Classification for Standards (ICS) system. It covers "Medical sciences and health care facilities in general". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 285 standards classified under ICS 11.020 (Medical sciences and health care facilities in general). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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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 languagee-Library read for1 day
This prAA represents common modifications to prHD 60364-7-710
2019-11-29: no xml because common mod
- Amendment21 pagesEnglish languagee-Library read for1 day
This document specifies contact tracing procedures for highly contagious respiratory infectious disease cases, including both symptomatic and asymptomatic infections for pandemic response. This document provides: - an overview and general procedures of contact tracing; - requirements and privacy protection guidance in contact tracing.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the method for declaring the technical classification relating to acoustics for a Product Standard including DoP, or European assessment document (EAD) including European Technical Approval (ETA) for a specific building product or equipment, or a family of building products or equipment. In particular, it gives advice on how to write technical specifications in response to the mandated characteristics on acoustics under the Construction Products Regulation.
NOTE 1 In the remainder of this document, the terms used relate to CEN and product standards. The concepts are, however, equally applicable to the European Organisation for Technical Approvals (EOTA).
The purpose of this document is to assist the Technical Committees in preparing acoustic clauses to ensure that such product standards:
- are as homogeneous as possible, with each individual product standard having the same basic structure;
- are in full accordance with the standards for the measurement and declaration of acoustic properties;
- reflect the latest technical knowledge of methods of determining the acoustical properties from the specific family of building products or equipment under consideration.
NOTE 2 Annex A lists the European and International Standards to be used in the drafting of acoustic provisions standards. Annex B contains guidance on choosing appropriate properties. Annex C describes the relevant measured acoustic properties for common products.
- Technical report41 pagesEnglish languagee-Library read for1 day
This document specifies the functions and quality evaluation of the specimen collection booth as part of pandemic response management for respiratory diseases. NOTE COVID-19 is an example of a disease for which such a specimen-collection booth is developed.
- Standard18 pagesEnglish languagesale 15% off
This document specifies requirements for the management of information related to response resources for a public health emergency (PHE) response, from the perspective of information and communication technology (ICT). This document provides: - an overview of response resource information management; - requirements for managing response resource information including: - information collection; - information storage; - information disposal; - information distribution. The requirements in this document can only be effectively applied, if information exchange described in REF Section_sec_5 \r \h Clause 5 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0035000000 is supported at both municipal and national levels.
- Standard8 pagesEnglish languagesale 15% off
This document specifies the method for declaring the technical classification relating to acoustics for a Product Standard including DoP, or European assessment document (EAD) including European Technical Approval (ETA) for a specific building product or equipment, or a family of building products or equipment. In particular, it gives advice on how to write technical specifications in response to the mandated characteristics on acoustics under the Construction Products Regulation.
NOTE 1 In the remainder of this document, the terms used relate to CEN and product standards. The concepts are, however, equally applicable to the European Organisation for Technical Approvals (EOTA).
The purpose of this document is to assist the Technical Committees in preparing acoustic clauses to ensure that such product standards:
- are as homogeneous as possible, with each individual product standard having the same basic structure;
- are in full accordance with the standards for the measurement and declaration of acoustic properties;
- reflect the latest technical knowledge of methods of determining the acoustical properties from the specific family of building products or equipment under consideration.
NOTE 2 Annex A lists the European and International Standards to be used in the drafting of acoustic provisions standards. Annex B contains guidance on choosing appropriate properties. Annex C describes the relevant measured acoustic properties for common products.
- Technical report41 pagesEnglish languagee-Library read for1 day
- Amendment9 pagesEnglish languagee-Library read for1 day
- Amendment9 pagesEnglish languagee-Library read for1 day
This document presents guidelines to establish, implement, evaluate and continuously improve wellbeing, to promote healthy ageing at the level of community and individual members. This document is applicable to any community, regardless of size, type and nature. Management of occupational safety and health is outside of the scope of this document. This document does not cover economic and financial aspects.
- Standard19 pagesEnglish languagesale 15% off
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
This document specifies the core elements, the description model and typical categories of internet healthcare service patterns. This document applies to the development and application of internet healthcare service patterns.
- Technical specification11 pagesEnglish 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 provides recommendations for healthcare organizations on how to effectively manage and classifies patients who are infected with respiratory infectious diseases, especially during a pandemic. It covers various aspects of patient care, infection control and healthcare facility management to ensure the safety of both patients and healthcare workers in such situations.
- Technical specification10 pagesEnglish languagesale 15% off
IEC SRD 63426:2024 classifies elements suitable for an AAL connected home environment based on AAL system components. This document defines instances which are specific examples of elements used in an AAL connected home environment (AAL CHE).
An element defined in this document is a specialized and subdivided classification of a connected home environment. An instance is a specific example of an element used in an AAL CHE.
This document lists standards applicable to AAL CHE elements and AAL CHE instances, with a focus on interoperability and connectivity.
- Standardization document15 pagesEnglish languagesale 15% off
This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.
- Standard20 pagesEnglish languagee-Library read for1 day
This document provides guidance on essential social welfare services and medical support for socially vulnerable groups, who are likely to be in greater danger in the event of a respiratory epidemic disaster. This document applies to those: a) providing essential social welfare services for socially vulnerable groups in the event of a respiratory epidemic disaster; b) providing essential medical support for socially vulnerable groups in the event of a respiratory epidemic disaster.
- Technical specification11 pagesEnglish languagesale 15% off
This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.
- Standard20 pagesEnglish languagee-Library read for1 day
This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP. Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.
- Standard12 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document provides guidance for the daily activities to practice social distancing and source control as pre-emptive actions to prevent infectious disease.
- Standard11 pagesEnglish languagesale 15% off
IEC SRD 63473:2024 is to describe the process of building an inventory of international standards based on use cases, mapping these international standards to individual use cases, and providing a visual representation in the IEC mapping platform.
This document identifies the main categories of international standards applicable to AAL systems and applies these international standards to AAL components and the complete AAL system.
Although there are national and regional standards that can address parts of AAL systems, this document will focus only on standards developed at the international level (e.g., IEC, ISO, ITU‑T).
- Standardization document21 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
3.1 These terms have application to forensic practice.
3.1.1 For ASTM International standards, the standard designation is followed by a dash and a two-digit year designation in bold type, for example, E2161 - 19. The year citation references the year of publication of the standard from which the entry is taken, not necessarily the current year of publication of the standard.
3.1.2 Citations from other than ASTM International standards may include an abbreviation and the standard number followed by a four-digit year designation in bold type, for example, ISO 9000:2015. The year citation references the year of publication of the standard from which the entry is taken. Such standards may also be referenced by a name followed by a year designation, for example, IUPAC Gold Book 2020 (1).5 Abbreviations are detailed under, “All terms sourced from other standards than Committee E30 standards are listed in Section 2.”
3.1.3 For entries followed simply by a reference, for example, ISO 9000:2015 or E456 - 17, the reader can assume that the entry is accurately copied from the reference with no modifications except for ASTM International format conventions. For entries that are slightly modified versions of something from a known source, reference citations read, “Based upon definition by…” Following the “by” is the source name and year that the entry was taken or modified. The boldface numbers in parentheses refer to a list of references at the end of the terminology.
3.1.4 For entries from textbooks, a reference following the entry has the name or title of the text, author(s), edition (if applicable), and the year of publication or copyright.
3.1.5 An entry could have a definition of a term with one reference, and the discussion following the definition has a different reference.
3.1.6 Citations from Merriam-Webster’s Online Dictionary (2) include the date retrieved from the online dictionary and the URL of the cited term and definition.
3.1.7 Each defin...
SCOPE
1.1 This terminology is the compilation of all terms used by Committee E30 on Forensic Sciences.
1.1.1 This terminology consists mostly of definitions that are specific to forensic science and forensic practice. Meanings of the same terms used outside of forensic practice can be found in other compilations or dictionaries of general usage.
1.1.2 The specific E30 subcommittee (SC) that has responsibility for each term is the first attribution noted, in square brackets, after the definition. The designation of the standard(s) in which the terms appear is given after the subcommittee. The wording of an entry cannot be changed without approval per the Committee E30 Bylaws. Users of this compilation should also review any SC terminology standard for more details or interpretations of these terms and their use by the SC.
1.2 This terminology is a tool for managing the committee’s terminology. This includes finding, eliminating, and preventing redundancies in which two or more terms relating the same concept are defined in different words.
1.3 This standard 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard36 pagesEnglish languagesale 15% off
- Standard36 pagesEnglish languagesale 15% off
This document provides guidelines to prevent cross-infections within a hospital, with a specific focus on the separate operation of wards dedicated to highly contagious respiratory infectious diseases, transportation of confirmed cases of highly contagious respiratory infectious diseases, disinfection, waste management, etc. This document applies to the following: a) separate operation of wards dedicated to highly contagious respiratory infectious diseases; b) transportation of confirmed cases of highly contagious respiratory infectious diseases and roles of the dedicated healthcare team in a ward dedicated to highly contagious respiratory infectious diseases; c) cleaning, disinfection, and waste management.
- Technical specification28 pagesEnglish languagesale 15% off
This document provides a collection of design considerations from existing international standards as well as best practices and observations obtained from the home healthcare field. This document is intended to be used as a reference for designing accessibility and usability of home healthcare products and associated services, and environments designed for non-professional users. This document does not provide information on the use of home healthcare products by healthcare professionals regardless of the place and facility of use.
- Technical report25 pagesEnglish languagesale 15% off
This document specifies the infection prevention and control (IPC) measures for cross-border workers. It is applicable only in the circumstance of novel infectious disease outbreak while valid vaccine or drug for treatment are not available. It can be used for the purpose of maintaining economic activities when a country that workers need to enter blocks its border due to a pandemic or epidemic (Annex A). This document provides information on the key aspects and details of the process requirements, procedures for selecting service providers, such as travel management company, and procedures for cross-border workers amidst a pandemic, encompassing the complete set of stages from ‘pre-departure’, ‘border crossing’, ‘quarantine and commute’, to ‘return’, and is addressed to all stakeholders involved in travel, whether from the public or private sector. NOTE Stakeholders are comprised of but not limited to health authority, healthcare organization and screening stations, accommodation services, transportation services, travel agencies, and private companies including their contractors and providers.
- Technical specification23 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 document specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems. This document covers facility readiness, hand hygiene education and training, monitoring, performance, promotion and identifying key issues that require attention for improvement. Procedures for surgical hand preparation are not addressed in this document. Furthermore, this document does not take into consideration, surface disinfection, instrument disinfection, ultraviolet irradiation (UV-C), heat sterilization, room fogging or electrostatic spraying devices and any other methods typically not designed or suitable for human hand hygiene purposes. Excluding surgical hand preparation, this document applies specifically to clinical healthcare workers, patients and visitors.
- Standard33 pagesEnglish languagesale 15% off
- Standard45 pagesEnglish and French languagesale 15% off
The purpose of this document is to provide organizations with requirements to deliver high-quality healthcare and specifies requirements for management systems for quality in healthcare organizations when an organization desires to: a) demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements; b) enhance service user experience during the continuum of care and continually improve healthcare quality; and c) create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centred care. The requirements of this document are based on recognized best practices and are intended to be applicable to any organization providing healthcare services, regardless of its type, size, or the services it provides.
- Standard35 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.
4.4 All categories must be considered for applicability.
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.
1.5 The units cited in the referenced standard should be used.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide27 pagesEnglish languagesale 15% off
- Guide27 pagesEnglish languagesale 15% off
IEC SRD 63416:2023 describes ethical considerations that are relevant when developing AAL systems and AAL services.
This document covers AAL-specific issues related to AI that supplement those ethical considerations already addressed in other AI documents. Examples include the WHO and OECD principles of AI and those of the High-Level Expert Group on Artificial Intelligence set up by the European Commission.
This document analyses whether these frameworks for the governance of AI are sufficient to meet the requirements of the AAL environment and in particular to meet the needs of AAL care recipients.
The objective of the ethical assessment is to create concrete and clear ethical guidelines that can be used as checklists in AAL service and system platform design, development and implementation.
- Standardization document25 pagesEnglish languagesale 15% off
SCOPE
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.
1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.5 This standard 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification11 pagesEnglish languagesale 15% off
- Technical specification11 pagesEnglish languagesale 15% off
This document describes the requirements, operational principles, and procedures of the temporary medical facility (TMF) regarding: a) planning; b) staffing; c) patient management; d) discharge and termination of isolation for patients with infectious diseases in the context of ongoing widespread community transmission.
- Standard14 pagesEnglish languagesale 15% off
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 languagee-Library read for1 day
- Technical report13 pagesEnglish languagee-Library read for1 day
This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.
- Standard57 pagesEnglish languagee-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 languagee-Library read for1 day
- Technical report13 pagesEnglish languagee-Library read for1 day
- Technical specification9 pagesEnglish languagesale 15% off
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
This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.
- Standard57 pagesEnglish languagee-Library read for1 day
This document specifies the operation of a walk-through screening station (WTSS) for mass testing as part of pandemic response management. NOTE COVID-19 is an exemplary disease for which such a station is developed.
- Standard15 pagesEnglish languagesale 15% off
IEC 60050-871:2018 gives the general terminology used in active assisted living, as well as general terms pertaining to specific applications and associated technologies. This terminology is consistent with the terminology developed in the other specialized parts of the IEV.
It has the status of a horizontal standard in accordance with IEC Guide 108.
- Standard98 pagesEnglish and French languagee-Library read for1 day
- Standard84 pagesEnglish and French languagesale 15% off
SCOPE
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to microphysiological systems (MPS). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for MPS.
1.2 The terms and nomenclature presented in this standard are for the specific purpose of unifying the language used in MPS standards and are not intended for labeling of regulated medical products.
1.3 This standard 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 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
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard 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 appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommend...
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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.
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