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ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644-8). The following are outside the scope of ISO 14644-15:2017: - health and safety requirements; - compatibility with cleaning agents and techniques; - cleanability; - biocontamination; - specific requirements of equipment and materials for processes and products; - design details of equipment.

 

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.

 

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 the quality characteristics of the NOx reduction agent AUS 32 (aqueous urea solution) which is needed to operate selective catalytic reduction (SCR) converter systems in motor vehicles with diesel engines. SCR converter systems are particularly suitable for selectively reducing the nitrogen oxide (NOx) emissions of diesel engines.

 

 

This document describes common capabilities, requirements and a supporting information model for logging of events in AI systems. This document is designed to be used with a risk management system.

 

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 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.

 

This document specifies the terminology, classification and the methods that are used for the grading and description of single unmounted polished diamonds over 0,25 carat (ct). This document applies to natural, unmounted, polished diamonds. It is not to be used for fancy coloured diamonds, synthetic diamonds, treated diamonds (other than is allowed for in 7.4), nor for assembled stones

 

ISO 8653:2016 specifies a method to measure the ring-size using a ring stick with defined characteristics, which is mainly used during manufacturing steps, and specifies the designation of the ring-size. NOTE For jeweller-consumer relationships, the finger size is measured with a finger gauge set made up of a ring for each size with the same diameter and tolerance than the ring stick ones.

 

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 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 describes a highly specific method for the enumeration of Escherichia coli (E. coli) in water. The method is based on membrane filtration, subsequent culture at 44 °C on a chromogenic agar medium containing a chromogenic ingredient for the detection of the enzyme ß-glucuronidase, and calculation of the number of target organisms in the sample. Because of the high specificity of the method, this document is suitable for waters with high levels of background bacteria, such as surface waters including bathing water and wastewater. E. coli strains which do not grow at 44 °C and those that are ß-glucuronidase negative, such as E. coli O157, will not be detected as E. coli by this method.