SFS Suomen Standardit

 

1.1 In scope This document defines a Recommended Practice for Product Structure validation. The objective is to validate the product structure of data ingested, extracted or re-used by the archive. This document defines a method to uniquely identify each node in the product structure and to uniquely define the structure of each assembly node. 1.2 Out of scope This document will not provide validation properties for documents; CAD or other.

 

This document is intended to provide specific levels of information relevant to the identification of a Pharmaceutical Product or groups of Pharmaceutical Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Pharmaceutical Products to be unequivocally identified on a global level. References to other normative IDMP standards and specifications for data exchange mechanisms for pharmaceutical product information are included in Clause 2, to be applied in the context of this document. Medicinal products for veterinary use are out of scope of this document.

 

This document specifies a method using light microscopy for the differentiation of the colouration process of fabrics, between dyeing or printing with pigments and, dyeing or printing with dyes. This document is applicable to coloured fabrics with the exception of those made of fibres coloured by melt or dope dyeing.

 

This document specifies an extension of evaluation methods and activities for cryptographic protocols based on ISO/IEC 15408-4 that provides a framework for evaluation methods and activities. This document provides a mapping between the work items for cryptographic protocol evaluation and the associated evaluation activities or evaluation methods. Additionally, this document also provides security assurance classification based on the cryptographic assessment performed by automated provers in four different levels of increasing assurance.

 

This document specifies safety requirements which need to be observed at design, calculation, manufacture, installation, maintenance, of mobile, temporary installed tents with more than 50 m2 ground area. This document applies also to multiple small tents which are normally not covered by this document and will be installed close together and exceed 50 m2 in sum. NOTE Information is given in Annex C on examination and approval.

 

This document specifies business requirements for processes intended to preserve digital data. NOTE Data are stored and maintained for the purpose of retrievability and usability during the required archiving period. In addition, for the purpose of some business requirements, data are authentically preserved and accessed. This document is intended to allow for different implementations based on a company’s specific business environment. This document is not intended to incorporate company specific requirements and does not dictate specific organizational structures within a company. This document does not specify a design or an implementation of an archive system. Actual implementations can distribute responsibilities or break out functionality differently. This document assumes that all requirements for configuration management of the product data are in place and therefore are not specifically described in this document.

 

This document specifies the general characteristics, the conditions for qualification, acceptance and quality assurance, as well as the test programs and groups for non-latching electromagnetic, hermetically sealed relays intended for use in a temperature range from - 55 °C to 125 °C continuous.

 

This document specifies characteristics for 10 A aerospace relays with the following variations of mounting means (e.g. vertical, horizontal), terminal styles (e.g. hooks, pins for soldering, pins for sockets) the associated finishing (e.g. tin plated, gold plated) and coil voltages (e.g. 6 VDC 12 VDC 28 VDC 48 VDC, 115 VAC) for relays with 2, 4 or 6 poles and with or without internal suppressors or LIE protection. The built-in suppressor limits the voltage transients resulting from the electrical power shut off. The relay sockets are not described in this document.

 

This document specifies the test procedures of electromechanical all-or-nothing relays for use in aircraft electrical systems to EN 2282. This document represents the aeronautical version of the standard EN 116000-3 from which it draws inspiration.

 

This document specifies the requirements for determining fatigue crack growth rates using corner-crack (CC) test pieces. Crack development is measured using a potential-drop system, and the calculated crack depths can be corrected via marker bands created on the fracture surface during the test. Results are expressed in terms of the crack-tip stress-intensity range (?K), with crack depths and test stress level noted.

 

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.

 

 

This document specifies a core set of vocabulary, architecture concepts and architecting principles associated with the architecture practice applicable to various entities such as enterprises, business components, capability areas, mission areas, missions, systems, systems of systems, families of systems, infrastructure, products, services, product lines, hardware, software applications and technologies. This document is intended for: This document does not address terms and definitions unique to specific application domains or areas. This document does not address concepts related to architecture competencies.

 

This document specifies the requirements and provides guidance for establishing, implementing, maintaining and continually improving an AI management system within the context of an organization. This document is intended for use by an organization providing or using products or services that utilize AI systems. This document helps the organization develop or use AI systems responsibly in pursuing its objectives and meet applicable regulatory requirements, obligations related to interested parties and expectations from them. This document is applicable to any organization, regardless of size, type and nature, that provides or uses products or services that utilize AI systems.

 

This document specifies requirements for single stage and multi-stage centrifugal pumps with mechanical seal or soft packing for use in automatic sprinkler systems and is for use with EN 12845 and EN 17451 . This document is applicable for the following pumps, independent of installed orientation (vertical, horizontal or sloped according to the manufacturer indications): - end suction pumps (close coupled or long coupled) of the back pull-out type pump; - axial horizontal split case pumps; - ring section pumps including multistage single or multi outlet; - single or multistage inline pumps (pump with inlet and outlet in line); - submersible motor borehole pumps. This document is also applicable to vertical turbine pumps.

 

This document specifies a method for the selective enumeration of bifidobacteria in milk products by using a colony-count technique at 37 °C under anaerobic conditions. The method is applicable to milk products, such as fermented (e.g. yoghurts) and non-fermented milks (e.g. pasteurized milks, skim milks, whey protein concentrates), milk powders and formulae (e.g. infant formulae, follow-up formulae for older infants, products for young children) where these microorganisms are present and viable, in combination with other lactic acid bacteria or alone. The method is also applicable to starter and probiotic cultures. For proposed quality criteria of dairy products, see, for example, CXS 243-2003. Bifidobacteria used in milk products usually belong to the following species (e.g. References [7] and [10]): — Bifidobacterium adolescentis; — B. animalis subsp. animalis; — B. animalis subsp. lactis; — B. bifidum; — B. breve; — B. longum subsp. infantis; — B. longum subsp. longum.

 

This document specifies the precious metal content in solders suitable for use in the production of jewellery made of precious metal alloys.

 

This document specifies a method of sampling precious metals and precious metal alloys for the determination of their precious metal content and for the assessment of their homogeneity. The document is applicable to raw materials, semi-finished products and finished products and is intended to be used only for the sampling of entirely metallic materials. NOTE 1 Standards for determination of precious metals contents for different metals are listed in the Bibliography. NOTE 2 For assaying techniques different from the listed ones other sampling procedures can be required. NOTE 3 For the purpose of production control or lot inspections the International Standards for the sampling indicated in the Bibliography or corresponding guidelines can be applied in addition.

 

This document describes a non-destructive method to verify (confirm) the precious metal fineness of finished and semifinished jewellery item(s) considered homogeneous by ED-XRF (energy dispersive X-ray fluorescence), including alloys according to ISO 9202. This document is not suitable for any coated items. WD-XRF (wavelength dispersive X-ray fluorescence) equipment cannot be used.

 

This document specifies the requirements, test methods, inspection, marking, packaging, transportation, storage, quality certificate and the order (or contract) information of one kilogram gold bars. This document is applicable to one-kilogram cast gold bars produced for investment markets or industrial (jewellery, electronic) markets.