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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.

1.1 Scope (1) EN 199316 provides rules for the structural design of plated steel structures that have the form of a shell of revolution (axisymmetric shell). (2) This document is applicable to unstiffened fabricated axisymmetric shells formed from isotropic rolled plates using both algebraic and computational procedures, and to stiffened axisymmetric shells with different wall constructions using computational procedures. It also applies to associated circular or annular plates and to beam section rings and stringer stiffeners where they form part of the complete shell structure. The general computational procedures are applicable to all shell forms. (3) This document does not apply to manufactured shells or to shell panels or to elliptical shell forms, except that its computational procedures are applicable to all shell structures. This document does not apply to structures under seismic or other dynamic loading. It does not cover the aspects of leakage of stored liquids or solids. (4) Cylindrical and conical panels are not explicitly covered by this document. However, the provisions of 9.8 can be used provided that appropriate boundary conditions are taken into account. (5) This document defines the characteristic and design values of the resistance of the structure. (6) This document is concerned with the requirements for design against the ultimate limit states of: — plastic failure; — cyclic plasticity; — buckling; — fatigue. (7) Overall equilibrium of the structure (sliding, uplifting, overturning) is not included in this document. Special considerations for specific applications are included in the relevant application parts of EN 1993. (8) Detailed formulae for the simple calculation of unstiffened cylinders, cones and spherical domes are given in the Annexes. (9) Provisions for simple calculations on specific stiffened shell types are given in EN 199341. (10) This document is intended for application to steel shell structures. Where no standard exists for shell structures made of other metals, including high strength steels, the provisions of this document are applicable provided the appropriate material properties of the metal are taken into account. (11) The provisions of this document are intended to be applied within the temperature ranges defined in the relevant EN 1993 application parts. (12) Where no application part defines a different range, this document applies to structures within the following limits: — design metal temperatures lie within the range −50 °C to +100 °C, except when using the special provisions given in 5.1; — radius to thickness ratios (r/t) within the range 50 to 2 000; — manufactured circular hollow sections according to EN 10210 and EN 10219 are outside the scope of this document and are covered by EN 199311. However, if no other provisions are available, the rules of this document are useful for manufactured circular hollow sections. In particular, this document is applicable to the design of manufactured piles (see EN 19935) provided the imperfections and tolerance requirements of EN 19935 are adopted in place of those specified in this document, and where no other standard covers the specific pile geometry. NOTE 1 Experimental and theoretical data relating to manufactured circular hollow sections were not considered when this document was drafted. The application of this document to such structures therefore remains the responsibility of the user. NOTE 2 The stress design rules of this document can be rather conservative if applied to some geometries and loading conditions for relatively thickwalled shells. NOTE 3 Thinner shells than r/t = 2 000 can be treated using these provisions but the provisions have not been verified for such thin shells. NOTE 4 The maximum temperature is restricted so that the influence of creep can be ignored where high temperature creep effects are not covered by the relevant application part. [...]

1.1 Scope of EN 1993 4 1 (1) prEN 1993 4 1 provides rules for the structural design of steel silos of circular or rectangular plan-form, being free-standing (on ground) or supported on a structural framework (elevated). (2) prEN 1993 4 1 is applicable to silos constructed from isotropic rolled plates that are stiffened or unstiffened, from corrugated sheeting that is stiffened or unstiffened and from flat or corrugated plates assembled into box structures of different geometries. It applies to vertical walls, hoppers, roof structures, transition junctions and support structures. (3) prEN 1993 4 1 does not apply to storage vessels for silage and haylage, or to the storage of materials that are not free-flowing (see EN 1991 4). This Part 4-1 also does not cover: - resistance to fire; - cylindrical silos with internal subdivisions; - internal structures within a single silo (except for internal ties, as defined in 12.5); - silos with capacity less than 100 kN (10 tonnes); - hoppers that are supported on a structural framework; - cases where special measures are necessary to limit the consequences of accidents. (4) This document is applicable to silos within the following dimensional limits (see EN 1991-4): - Silo aspect ratio hb/dc < 10 - Silo total height hb < 70 m - Silo equivalent diameter dc < 60 m NOTE These dimensional limitations are more limited than those of EN 1991-4 which also applies to silos constructed from other materials. (5) Where this standard applies to circular planform silos, the geometric form is restricted to axisymmetric structures, but unsymmetrical actions on them and supports that induce forces in the silo structure that are not axisymmetric are included. (6) This part is concerned only with the requirements for resistance and stability of steel silos. For other requirements (such as operational safety, functional performance, fabrication and erection, quality control, details like man-holes, flanges, filling devices, outlet gates and feeders, etc.), see other relevant standards and information. (7) This part is concerned with both isolated silo structures and silos that are connected to others to form a battery of silos, but throughout this document the term silo refers to a single cell within a battery. (8) Provisions relating to special requirements of seismic design are provided in EN 1998 4, which complements or adapts the provisions of Eurocode 3 specifically for this purpose. (9) The structural design of supporting structures for the silo are dealt with in EN 1993 1 1. The supporting structure is deemed to consist of all structural elements beneath the bottom flange of the lowest ring of the silo (see Figure 1.1), though information on some forms of support structure is given in Clause 8 of this document. (10) Foundations in reinforced concrete for steel silos are dealt with in EN 1992 (all parts) and EN 1997 (all parts). 1.2 Assumptions (1) Unless specifically stated, the provisions of EN 1990, EN 1991 (all parts) and EN 1993 1 (all parts) apply. (2) The design methods given in EN 1993 4 1 are applicable if: - the execution quality is as specified in EN 1090 2, and - the construction materials and products used are as specified in the relevant parts of EN 1993 (all parts), or in the relevant material and product specifications. Figure 1.1 - Terminology used in silo structures ...

(1) EN 1994-1-2 gives rules for the design of steel-concrete composite structures for the accidental design situation of fire exposure. It only identifies differences from, or supplements to, rules for normal temperature design. (2) EN 1994-1-2 only applies to structures, or parts of structures, that are within the scope of EN1994-1-1 and are designed accordingly.

EN 1994-2 gives design rules for steel-concrete composite bridges or members of bridges, supplementary to the general rules given in EN 1994-1-1.