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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

 

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

 

This document specifies a method for the determination of the boiling range distribution of petroleum products. The method is applicable to petroleum products and fractions with a final boiling point of 538 °C or lower at atmospheric pressure as determined by this document. This document does not apply to gasoline samples or gasoline components. The method is limited to products having a boiling range greater than 55 °C and having a vapour pressure sufficiently low to permit sampling at ambient temperature. The document describes two procedures. a) Procedure A allows a larger selection of columns and analysis conditions, such as packed and capillary columns as well as a thermal conductivity detector in addition to the flame ionization detector. Analysis times range from 14 min to 60 min. b) Procedure B is restricted to only three capillary columns and requires no sample dilution. The analysis time is reduced to about 8 min. Both procedures have been successfully applied to samples containing fatty acid methyl esters (FAME) up to 20 % (volume fraction). NOTE For the purposes of this document, the terms "% (mass fraction)" and "% (volume fraction)" are used to represent the mass fraction (µ), the volume fraction (f) of a material.

 

This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. This document does not apply to the enumeration or characterization of viral, prion or protozoan contaminants. This includes the extraction and detection of the causative agents of transmissible spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 2 Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. NOTE 3 ISO/TS 22456 provides specific guidance for bioburden testing for biologics and tissue-based products where this testing is conducted in relation to product sterilization. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

 

This part of ISO 7250 provides worldwide and regional tables of design ranges for use with product standards for equipment design and safety that require ISO 7250 body measurement data input. Anthropometric data for technological design are used and presented in many standards. Therefore, it is critical to update and revise those values in a timely manner, as the body sizes and variation of member body populations change with time. Further, the schedule of member body anthropometric surveys varies widely. Many industrial products are developed for regional or worldwide markets without a clear presentation of regional and worldwide ISO 7250 design ranges. Users of standards require the most appropriate body measurement values for their intended applications. Together with iso:proj:84822ISO/TR 7250-2, which serves as a continuously updated data source for most current anthropometric data from individual member bodies, this part of ISO 7250 provides a periodically updated normative design values for worldwide and regional design ranges, with guidance on sex differences. This part of ISO 7250 is intended as the single source of normative anthropometric data for equipment design guidance in standards. In this part, data from all the member bodies found in iso:proj:84822ISO/TR 7250-2 are considered simultaneously, whereas in ISO/TR 7250-2, member body data are presented separately for each member body. While there are sources for individual member body data in iso:proj:84822ISO/TR 7250-2, most standards do not use individual member body data for technological specification. This part of ISO 7250 is to be used whenever normative worldwide or regional anthropometric data are needed. In cases when there are no suitable measurements in this part of ISO 7250, the methods and justifications used in arriving at regional and worldwide values from the body measurement data of individual populations can be used with suitable measurement data. The scope of this part of ISO 7250 is limited to the presentation of univariate design ranges of the type currently utilized in product standards (e.g. P1, P5, P95, and P99) and does not address shortcomings of using those values in multivariate designs. A separate standard on multivariate design is in preparation. In addition, this part of ISO 7250 does not address body measurements used in product standards that are not defined in iso:proj:65246ISO 7250-1. The methods used in developing this part of ISO 7250 do not take into account the population size or sampling methodology of the member bodies, so statistical values from a sparsely populated member body could set regional or worldwide upper or lower limits. The reader is referred to iso:proj:84822ISO/TR 7250-2 for details on sampling methods used in national surveys.

 

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.

 

This document specifies a spectrophotometric determination of the pHT of sea water on the total hydrogen ion concentration pH scale. The total hydrogen ion concentration, [H+]t, is expressed as moles per kilogram of sea water. The method is suitable for assaying oceanic levels of pHT from 7,4 to 8,2 for normal sea water of practical salinity ranging from 20 to 40.

 

This document specifies procedures for sampling, capture and preservation of environmental DNA (eDNA) in aquatic environments, stemming from organisms that are or have recently been present in a waterbody, have visited it or whose DNA has been introduced to the waterbody through some mechanism. This document also covers procedures for avoiding sample contamination and ensuring DNA quality, key properties of the filtering procedure and equipment and reporting standards. This document does not include the collection of eDNA from biofilms, sediments or similar sample types and does not cover sampling designs.

 

This document specifies procedures for sampling, capture and preservation of environmental DNA (eDNA) in aquatic environments, stemming from organisms — that are or have recently been present in a water body, or — whose DNA has been introduced to the water body through some mechanism. This document also specifies procedures for avoiding sample contamination and ensuring environmental DNA integrity during water filtration and sample preservation. It also specifies the required equipment and metadata reporting. This document excludes: — methods for the collection of eDNA from biofilms, sediments or similar sample types; — passive sampling methods; — sampling designs.

 

This document specifies a method for sampling and handling earthworms from field soils as a prerequisite for using these animals as bioindicators (e.g. to assess the quality of a soil as a habitat for organisms). This document applies to all terrestrial biotopes in which earthworms occur. The sampling design of field studies in general is given in ISO 18400-101 and guidance on the determination of effects of pollutants on earthworms in field situations is given in ISO 11268-3. These aspects can vary according to the national requirements or the climatic/regional conditions of the site to be sampled (see also Annex C). This document is not applicable for semi-terrestrial soils and it can be difficult to use under extreme climatic or geographical conditions (e.g. in high mountains). Methods for some other soil organism groups, such as collembolans, are covered in other parts of ISO 23611.

 

This document specifies a method for sampling and handling earthworms from field soils as a prerequisite for using these animals as bioindicators (e.g. to assess the quality of a soil as a habitat for organisms). This document is applicable to all terrestrial biotopes in which earthworms occur. This document does not apply to semi-terrestrial soils (i.e. soils that are partly aquatic, such as bogs, beaches, marshes, stream margins) and it can be difficult to use under extreme climatic or geographical conditions (e.g. in high mountains). Methods for other soil organism groups, such as micro-arthropods and enchytraeids (mesofauna), are covered in other parts of the ISO 23611 series.

 

This document provides requirements and recommendations for the design of field studies with soil invertebrates (e.g. for the monitoring of the quality of a soil as a habitat for organisms). It applies to all terrestrial biotopes inhabited by soil invertebrates, although this information can vary according to the national requirements or the climatic and regional conditions of the site to be sampled. NOTE While this document aims to be applicable globally, the existing information refers mostly to temperate regions. However, the (few) studies from other (tropical and boreal) regions, as well as theoretical considerations, allow the conclusion that the principles laid down in this document are generally valid.[1],[11],[12],[13]

 

This part of ISO 23611 provides guidance for the design of field studies with soil invertebrates (e.g. for the monitoring of the quality of a soil as a habitat for organisms). Detailed information on the sampling of the most important soil organisms is provided in the other parts of this International Standard (ISO 23611-1 to ISO 23611-5). This part of ISO 23611 is used for all terrestrial biotopes in which soil invertebrates occur. Basic information on the design of field studies in general is already laid down in ISO 10381-1. This information can vary according to the national requirements or the climatic/regional conditions of the site to be sampled. NOTE While this part of ISO 23611 aims to be applicable globally for all terrestrial sites that are inhabited by soil invertebrates, the existing information refers mostly to temperate regions. However, the (few) studies from other (tropical and boreal) regions, as well as theoretical considerations, allow the conclusion that the principles laid down in this part of ISO 23611 are generally valid, References [4], [6], [40], [21]. This part of ISO 23611 gives information on site-specific risk assessment of contaminated land, study of potential side effects of anthropogenic impacts (e.g. the application of chemicals or the building of roads), the biological classification and assessment of soils in order to determine the biological quality of soils, and longterm biogeographical monitoring in the context of nature protection or restoration, including global change (e.g. as in long-term ecological research projects).

 

This document describes a method for the determination of the acute toxicity to one of three specified species of marine copepod (Copepoda, Crustacea). This document is applicable to: a) industrial or sewage effluents, treated or untreated, after decantation, filtration or centrifugation if necessary; b) marine or estuarine waters; c) aqueous extracts (pore water, elutriates, eluates and leachates) from sediments; d) chemical substances which are soluble, or which can be maintained as a stable suspension or dispersion, under the conditions of the test.

 

This document contains terms and definitions relating to oil and alternative fuel spills and their control. This document provides standardized terminology relating to oil and alternative fuel spill response, defined as the broad range of activities related to spill cleanup, including environmental conditions, assessment, sampling, containment, recovery, dispersant use, un situ burning, shoreline cleanup and disposal.

 

 

This standard applies to lidars installed on road vehicles to measure or detect the surroundings of the vehicle. This standard applies to lidars used on all types of road vehicles regardless of vehicle classifications, including passenger cars, buses, commercial vehicles, trailers, etc. NOTE The definition of “Road Vehicles” includes M1-M3, N1-N3, and L6-L7 according to Consolidated Resolution on the Construction of Vehicles (R.E.3). This document specifies a series of test methods to assist in evaluating the performance of lidars, the tests should cover the following: 1. The common performance specifications (e.g., Range capability, Range precision) 2. The common performance characteristics (e.g., Anti-interference, Ghost points) 3. Possible alteration of performance test caused by environmental conditions 4. Lidar performance for the union of both ADAS or AD application scenarios This document does not specify test methods for reliability, functional safety, and cybersecurity. This document defines terms in the context of test methods for automotive lidar. This document provides an overview of applicable scenarios of automotive lidar (see Annex A).

 

This document provides requirements for establishing a specification document for a finite element analysis (FEA) for a mechanical product, including type, procedure, modelling principle, solution, analysis and evaluation of the solution results, solution results interpretation, solution results report, and documentary management. It is applicable for FEA based structural analysis for mechanical products.

 

This document outlines the concepts and principles for information management at a stage of maturity described as “information management according to ISO 19650”. This document provides recommendations for a framework to manage information including recording, versioning, organizing and making it available so that all actors achieve their objectives. This document is applicable to the whole life cycle of any asset, including strategic planning, initial design, engineering, development, documentation and construction, day-to-day operation, maintenance, refurbishment, repair and end-of-life. The framework can be adapted to assets or asset-related projects of any scale and complexity, so as not to hamper the flexibility and versatility that characterize the large range of potential procurement strategies and so as to address the cost of implementing this document.

 

This document specifies requirements for information management, in the form of a business process, within the whole life cycle of assets. This document can be applied to all types of assets, all stages of the asset life cycle, and all types of appointments, and applied by all types and sizes of organization.