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This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository. It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful. This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing ? Reference model: Overview (ISO/IEC 10746-1). This document is not intended to specify the internal architecture or database design of EHR systems.

This document outlines a core dataset designed for a concise dental data exchange intended to support continuity and coordination of care. It provides a conceptual framework for a dental data for exchange that can serve as the basis for implementation models. The content reflects an international perspective on organizing dental information for cross-border exchange. It offers guidance on the essential data elements that should be shared globally and proposes a standardized format for their representation. The document focuses on defining the structure of the data to be exchanged (“the what”) without prescribing the specific methods or technologies used for transmission (“the how”). It does not include guidance on operational workflows such as data entry, collection, summarization, or integration. Nor does it address the competencies required to perform those tasks. Furthermore, it is not intended as an implementation guide and does not cover the underlying technical infrastructure or the use of particular coding systems, data formats, or terminologies.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability is established in ISO/IEEE11073-10406:2012. Appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models are leveraged. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of communication functionality for personal telehealth basic ECG (1- to 3-lead ECG) devices is defined. Monitoring ECG devices are distinguished from diagnostic ECG equipment with respect to support for wearable ECG devices, limiting the number of leads supported by the equipment to three, and not requiring the capability of annotating or analysing the detected electrical activity to determine known cardiac phenomena. ISO/IEEE 11073-10406:2012 is consistent with the base framework and allows multifunction implementations by following multiple device specializations (e.g. ECG and respiration rate).

Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10417:2017 establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth glucose meters.

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics. The information model can be used in the human and veterinary domain since the principles are transferrable. Other standards and external terminological resources are referenced that are applicable to this document.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

ISO 25237:2017 contains principles and requirements for privacy protection using pseudonymization services for the protection of personal health information. This document is applicable to organizations who wish to undertake pseudonymization processes for themselves or to organizations who make a claim of trustworthiness for operations engaged in pseudonymization services. ISO 25237:2017 - defines one basic concept for pseudonymization (see Clause 5), - defines one basic methodology for pseudonymization services including organizational, as well as technical aspects (see Clause 6), - specifies a policy framework and minimal requirements for controlled re-identification (see Clause 7), - gives an overview of different use cases for pseudonymization that can be both reversible and irreversible (see Annex A), - gives a guide to risk assessment for re-identification (see Annex B), - provides an example of a system that uses de-identification (see Annex C), - provides informative requirements to an interoperability to pseudonymization services (see Annex D), and - specifies a policy framework and minimal requirements for trustworthy practices for the operations of a pseudonymization service (see Annex E).

This document is applicable to metallic stop valves for use with water intended for human consumption. This document specifies: — requirements for the design of stop valves; — mechanical, hydraulic and acoustic requirements; — test methods; — marking requirements. This document is applicable to metallic stop valves, dimensions DN 10 to DN 100, for potable water installation in buildings for PN10 or PN16 and a distribution temperature of 65 °C. This document is applicable to stop valves in combination with accessories in the same body. This document is not applicable to regulating or servicing valves, designed specially to isolate sanitary tapware or other sanitary appliances.

This document specifies dimensions, materials and performance requirements, including methods of test, for hydraulic safety groups, of nominal sizes from DN 15 to DN 25, having working pressures from 0,1 MPa (1 bar) to 1,0 MPa (10 bar). Hydraulic safety groups are intended for fitting to the potable water supply of storage water heaters, having a maximum storage temperature of 95 °C. Hydraulic safety groups limit the pressure in hot water heaters, prevent the backflow of water into the main circuit and prevent the discharged water to get into contact with the water in the water heater. Hydraulic safety groups do not control the temperature. They ensure the hydraulic safety of water heaters if the mechanical resistance of the water heater remains at least equal to the rating pressure. NOTE The use of the device specified in this document does not override the need to use controls (e.g. thermostats and cut-outs) which act directly on the power sources of water heaters (for more information see Annex A).

This document specifies, dimensions, materials and performance requirements (including methods of test) for expansion groups, of nominal sizes from DN 15 to DN 25, having working pressures from 0,1 MPa (1 bar) to 1,0 MPa (10 bar). Expansion groups are fitted to the cold potable water supply only for expansion purposes, e.g. of storage water heaters, having a maximum distribution temperature of 95 °C. Expansion groups limit pressure in the water heater to which they are fitted, that is produced by thermal expansion of the water, prevent the backflow of water into the supply pipe and prevent the discharged water to get into contact with the water in the water heater. Expansion groups do not control temperature and alone do not constitute the protection required for storage water heaters. NOTE The use of the device specified in this document does not override the need to use controls (e.g. thermostats and thermal cut-outs) which act directly on the power sources of water heaters (for more information see Annex A).

This document specifies dimensions, materials and performance requirements, including methods of test, for pressure safety valves, of nominal sizes from DN 15 to DN 40, having working pressures from 0,1 MPa (1 bar) to 1,0 MPa (10 bar). Pressure safety valves are intended for fitting to the potable water supply of storage water heaters, having a maximum storage temperature of 95 °C. Pressure safety valves limit the pressure in hot water heaters. Pressure safety valves do not control the temperature and alone do not constitute the protection required for storage water heaters. They are not intended to act as expansion valves under normal conditions. NOTE The use of the device specified in this document does not override the need to use controls (e.g. thermostats and cut-outs) which act directly on the power sources of water heaters (for more information see Annex A).

This document specifies dimensions, materials and performance requirements (including methods of test) for expansion valves, of nominal sizes from DN 15 to DN 50, having working pressures ) from 0,1 MPa (1 bar) to 1,0 MPa (10 bar). Expansion valves are intended for fitting to the cold potable water supply of storage water heaters, having a maximum distribution temperature of 95 °C, for all energy sources. Expansion valves do not control the temperature and alone do not constitute the protection required for storage water heaters. Expansion valves limit pressure, in the water heaters to what they are fitted, that is produced by thermal expansion of the water. NOTE The use of the device specified in this document does not override the need to use controls (e.g. thermostats and cut-outs) which act directly on the power sources of water heaters (for more information see Annex A).

This document specifies application, general construction, performance and material requirements for frost resistant taps for outdoor use (FRT), PN 10. This document is applicable to potable water installations with a static pressure of maximum 1,0 MPa (10 bar) and a distribution temperature of maximum 25 °C (PWC). NOTE See Annex A for a general overview of this document’s organization and test sequence.

This document specifies width across flats dimensions for fasteners with external hexagon drive, for use in appropriate product standards and other relevant documents, e.g. for parts per drawing. This document is applicable to hexagon head bolts, screws and nuts with ISO metric thread, with or without flange. It may also be applicable to other types of fasteners (e.g. square head bolts, tapping screws with hexagon head, cylindrical nuts with flats, etc.).

1.1 This document specifies the requirements for materials, design, manufacture, testing inspection, safety equipment configuration and documentation (including instructions for first operation), for commonly-used types of gas-loaded accumulators and pressure vessels used to provide additional gas capacity for fluid power applications (see 1.2). 1.2 This document applies to the following types of components, defined as the pressure-containing envelope of gas-loaded accumulators: - bladder type; - diaphragm type; - piston type; - transfer type; - pressure vessels used to provide additional gas capacity. They consist of one or several parts joined together by a variety of mechanical means and by welding. 1.3 This document applies to gas-loaded accumulators which operate with the following conditions: - subject to an internal gauge pressure greater than 0,5 bar; - working temperature not lower than –50 °C and not higher than +200 °C; - containing all liquids and gases as defined in the European Legislation on Pressure Equipment, see Note. NOTE When the accumulator contains Group 1 liquids or gases, consideration relating to risks other than those required by the European Legislation on Pressure Equipment are not covered by this document and will be assessed separately.

This document provides requirements for side-pocket mandrels used in the petroleum and natural gas industry. This document includes specifying, selecting, designing, manufacturing, quality control, testing, and preparation for shipping of side-pocket mandrels. This document addresses standard side-pocket mandrel designs as well as high pressure and/or high temperature (HPHT) equipment rated greater than 103,43 MPa (15,000 psi) and/or greater than 177 °C (350 °F) wellbore conditions as proffered by API 1PER15K-1. This document does not address nor include requirements for end connections between the side-pocket mandrels and the well conduit. The installation and retrieval of side-pocket mandrels is outside the scope of this specification. Additionally, this document does not include specifications for center-set mandrels, mandrels that employ or support tubing-retrievable flow control devices or side-pocket mandrels that incorporate non-metallic materials for pressure containment. This document does not include gas-lift or any other flow-control valves or devices, latches, and/or associated wire line equipment that can or cannot be covered in other API specifications. The side-pocket mandrels to which this document refers are independent devices that can accept installation of flow control or other devices down-hole. This document is a supplement to API Spec 19G1, 2nd edition (2019), the requirements of which are applicable with the exceptions specified in this document.

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.