Miljö- och hälsoskydd. Säkerhet

This document specifies the requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers used for the measurement of the blood pressure of a subject.

Since this document covers both trending devices and absolute accuracy devices and focuses solely on requirements for the clinical investigation, representation of output is not covered by this document.

NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices which can be used to clarify for the intended user whether the shown data concerns absolute accurate values or trending values.

The requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous non-invasive automated sphygmomanometers.

NOTE 2 Subject populations can, for example, be represented by age or weight ranges.

NOTE 3 Conditions of use can, for example, refer to ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment or self-measurement as well as use in professional healthcare facility or the emergency medical service environment (EMS).

This document specifies additional disclosure requirements for the accompanying documents of continuous non-invasive automated sphygmomanometers that have undergone clinical investigation according to this document.

This document is not applicable to the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, the clinical investigation of an intermittent automated sphygmomanometer as given in ISO 81060-2, an intermittent automated non-invasive sphygmomanometer as given in IEC 80601-2-30 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

This International Standard provides guidance on the selection and conduct of appropriate test methods for the determination of biodegradation of organic chemicals in aerobic soils. lt does not describe any specific test method.

ISO 14239:2017 specifies six suitable incubation systems for measuring the rates and extent of mineralization of organic compounds in soil by measurement of carbon dioxide (CO2) evolution. All incubation systems are applicable to soluble or insoluble compounds but choice of system depends on the overall purposes of the study. ISO 14239:2017 does not apply to the use of such systems for material balance studies, which are often test-substance specific.

This International Standard gives guidance on the selection and method of appropriate tests for the determination of biodegradation of organic chemicals in soil samples under anaerobic conditions.

This International Standard specifies a rapid method for the determination of the potential rate of ammonium oxidation and inhibition of nitrification in soils. This method is suitable for all soils containing a population of nitrifying microorganisms. It can be used as a rapid screening test for monitoring soil quality and quality of wastes, and is suitable for testing the effects of cultivation methods, chemical substances [except volatiles, i.e. H > 1 (Henry’s constant)], extracts of biosolids and pollution in soils.

This part of ISO 17512 specifies a rapid screening method for evaluating the habitat function of soils and the influence of contaminants and chemicals on earthworm behaviour.

The sublethal test is a rapid method that reflects the bioavailability of contaminant mixtures in natural soils and substances spiked into soils to Eisenia fetida and Eisenia andrei. The avoidance behaviour of the worms is the measurement endpoint of the test. This test is not intended to replace the earthworm reproduction test.

Two different designs (a two section unit and a six section unit) have been developed and successfully applied. Both designs are applicable to either single-concentration (e.g. for assessing the quality of a field soil) or multi-concentration (e.g. for assessing the toxicity of a spiked chemical) tests. In both cases, the earthworms are allowed to make the initial choice on which compartment, control and a treatment [in the two section test vessel between right and left side; in the six section test vessel between the (3 + 3) alternating compartments], to enter.

This part of ISO 17512 specifies a rapid screening method for evaluating the habitat function of soils based on the avoidance behaviour of springtails.

The test is a rapid method that reflects the bioavailability of contaminants in natural soils and substances spiked into soils to Folsomia candida. In both cases, it is possible to establish a dose-response-relationship. The avoidance behaviour of the springtails is the measurement endpoint of the test. This test is not intended to replace the Collembola reproduction test.

This International Standard describes a technique for determining the effects of soil and soil-related materials on the seed germination and early growth of higher plants. These endpoints are useful indicators for the assessment of the quality of a soil as a habitat for organisms. This International Standard is applicable to all soils in which soil organisms are active and may be used to evaluate:

— the effects on plants due to toxicity of solid or liquid chemicals contaminating soil or materials (compost, sludge, waste) and chemicals added to soil;

— the changes in the soil effect on plants after restoration measures.

This document specifies a method for the measurement of several hydrolase activities (arylamidase, arylsulfatase, β-galactosidase, α-glucosidase, β-glucosidase, N-acetyl-glucosaminidase, acid, alkaline and global phosphatases, urease) simultaneously (or not) in soil samples, using colorimetric substrates. Enzyme activities of soil vary seasonally and depend on soil chemical, physical and biological characteristics. This method can be applied either to detect harmful effects on soil enzyme activities derived from toxic substances or other anthropogenic agents in contaminated soils against a control soil, or to test chemicals.

This document specifies a chronic test method for evaluating the habitat function of soils and determining effects of soil contaminants and substances on the reproduction of Hypoaspis aculeifer by – mainly – alimentary uptake. This method is applicable to soils and soil materials of unknown quality, e.g. from contaminated sites, amended soils, soils after remediation, industrial, agricultural or other sites under concern and waste materials (e.g. dredged material, municipal sludge from a wastewater treatment plant, composed material, or manure, especially those for possible land disposal). The reproduction (= number of juveniles) is the measured parameter of the test. The test reflects the bioavailability of a mixture of contaminants in natural soils (contaminated site soils) to a species which represents a trophic level which is not covered by other ISO standards. This test is not intended to replace the earthworm (see ISO 11268-2) or Collembola (see ISO 11267) reproduction tests since this species belongs not only to a different trophic group but also a different taxonomic group (= mites; i.e. arachnids) than those used usually.

Effects of substances are assessed using a standard soil, preferably a defined artificial soil substrate. For contaminated soils, the effects are determined in the soil to be tested and in a control soil. Depending on the objective of the study, the control and dilution substrate (dilution series of contaminated soil) are either an uncontaminated soil comparable to the soil to be tested (reference soil) or a standard soil (e.g. artificial soil).

This document provides information on how to use this method for testing samples (soils or substances) under temperate conditions.

This document is not applicable to substances for which the air/soil partition coefficient is greater than one, or to substances with vapour pressure exceeding 300 Pa at 25 °C.

NOTE The stability of the test substance cannot be ensured over the test period. No provision is made in the test method for monitoring the persistence of the substance under test.

This document specifies a protocol to identify ecotoxicological test specimens (mainly invertebrates and plants) to the species level, based on the DNA barcoding technique. This protocol can be used by laboratories performing DNA barcoding in order to standardize both the wet-lab and data analysis workflows as much as possible, and make them compliant with community standards and guidelines.

This document does not intend to specify one particular strain for each test method, but to accurately document the species/strain which was used.

NOTE 1 This does not imply that DNA barcoding is performed in parallel to each test run, but rather regularly (e.g. once a year, such as reference substance testing) and each time a new culture is started or new individuals are added to an ongoing culture.

This document does not aim at duplicating or replacing morphological-based species identifications. On the contrary, DNA barcoding is proposed as a complementary identification tool where morphology is inconclusive, or to diagnose cryptic species, in order to ensure that the results obtained from different ecotoxicological laboratories are referring to the same species or strain.

This document is applicable to identifications of immature forms which lack morphological diagnostic characters (eggs, larvae, juveniles), as well as the streamline identification of specimens collected in field monitoring studies, where large numbers of organisms from diverse taxa are classified.

NOTE 2 In principle, all species regularly used in ecotoxicological testing can be analysed by DNA barcoding. Besides the earthwoms Eisenia fetida and E. andrei, further examples for terrestrial species are Lumbricus terrestris, L. rubellus, Allolobophora chlorotica, Aporrectodea rosea, and A. caliginosa, Dendrodrilus rubidus, Enchytraeus albidus, and E. crypticus (Haplotaxida); Folsomia candida, F. fimetaria, Proisotoma minuta, and Sinella curviseta (Collembola); Hypoaspis aculeifer and Oppia nitens (Acari); Aleochara bilineata and Poecilus cupreus (Coleoptera); Scathophaga stercoraria, Musca autumnalis (Diptera) or Pardosa sp. (Arachnida). Nematodes or snails and even plants can also be added to this list.

This document describes a method to compare the quality of soils by determining the fatty acid composition of the leaves of plant species grown in these soils.

This method does not make it possible to determine an optimal value of the Omega-3 index and, therefore, cannot be used to determine the intrinsic quality of a soil from a specific area (regarded as homogeneous). The method can only be used to compare the quality of soils between various areas.

This method is applicable to:

— soils from contaminated sites;

— amended soils;

— soils after remediation;

— soil with waste products (e.g. slurry, manure, sludge or composts).

Alternatively, the quality of soils can be assessed by determining the Omega-3 index of Lactuca sativa seedlings grown in these soils under controlled conditions (i.e. phytotronic chamber) and by comparing these values to those obtained from control soils (see Annex B).

The purpose of this International Standard is to describe a method for assessing genotoxic effects (chromosome breakage or dysfunction of the mitotic spindle) of soils or soil materials on the secondary roots of a higher plant: Vicia faba (broad bean). This method allows the assessment of genotoxicity (toxicity for genetic material) of soils and soil materials like compost, sludge, waste, fertilizing matters, etc. Two ways of exposure can be considered: a direct exposure of plants to the soil (or soil material) which is relevant for the real genotoxic potential and an exposure of plants to the water extract of the soil (or soil material). This last way of exposure to a leachate or an eluate allows the detection of the mutagens which are not adsorbed to soils and which may be transferred to aquatic compartments. Moreover, this test may be used to evaluate genotoxic effects of chemical substances and to waters, effluents, etc.

This document focuses on monitoring the activity concentrations of radioactive gases, from which the activity released are calculated, in the gaseous effluent discharge from facilities producing positron emitting radionuclides and radiopharmaceuticals. Such facilities produce short half-life radionuclides used for medical purposes or research and may release gases typically including, but not limited to 18F, 11C, 15O, 13N. These facilities include accelerators, radiopharmacies, hospitals and universities. This document provides performance-based criteria for the design and use of air monitoring equipment including probes, transport lines, sample monitoring instruments, and gas flow measuring methods. This document also provides information covering monitoring program objectives, quality assurance, developing air monitoring control action levels, system optimisation, and system performance verification.

The goal of achieving an unbiased measurement is accomplished either by direct (in-line) measurement on the exhaust stream or with samples which are extracted (bypass) from the exhaust stream, in which the radioactive gases are well mixed in the airstream. This document sets forth performance criteria and recommendations to assist in obtaining valid measurements.

The criteria and recommendations of this document are aimed at monitoring which is conducted for regulatory compliance and system control. If existing air monitoring systems were not designed to the performance criteria and recommendations of this document, an evaluation of the performance of the system is advised. If deficiencies are discovered, it should be determined if retrofit is needed and practicable.

The criteria and recommendations of this document apply under both normal and off-normal operating conditions, provided that normal and off-normal conditions do not include production of aerosols or vapours. If the normal and/or off-normal conditions produce aerosols and vapours, then the aerosol collection principles of ISO 2889 also apply.

This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.

Bodies operating according to this document can provide validation/verification as first party, second party as well as third party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.

This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.

This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.

This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.

This document specifies principles and requirements for bodies performing validation and verification of environmental information.

Any programme requirements related to bodies are additional to the requirements of this document.

NOTE This document contains generic requirements and is neutral with regard to the validation/ verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.

This document specifies methods for recording the time history of the sound pressure produced by shooting with calibres of less than 20 mm or by detonation of explosive charges of less than 50 g TNT equivalent in locations within the shooting range. The location of the measurement can be the position of the shooter or any person in the shooting range. The time history of the sound pressure can be the basis for further analyses of exposure of persons to these kinds of sounds.

This document provides guidelines to assist organizations in establishing, documenting, implementing, maintaining and continually improving material circulation in their design and development in a systematic manner, using an environmental management system (EMS) framework.

These guidelines are intended to be used by those organizations that implement an EMS in accordance with ISO 14001. The guidelines can also help in integrating material circulation strategies in design and development when using other management systems. The guidelines can be applied to any organization regardless of its size or activity.

This document provides guidelines for design strategies on material circulation to achieve the material efficiency objectives of an organization, by focusing on the following aspects:

— Type and quantity of materials in products

— Product lifetime extension

— Recovery of products, parts, and materials

In design and development, many aspects are considered, such as safety, performance, and cost. Although important, they are not addressed in this document.

This document specifies requirements for the ice plug technique with liquid nitrogen or dry ice as refrigerant (cryogenic medium) on metal pipes of nuclear power plants. The freezing liquid can be water or water mixture (e.g. boric acid mixture).

This document specifies technical requirements of ice plug generation, formation judgment and removal, measures before, during and after ice plugging and requirements for personnel and non-destructive testing.

This document is applicable for maintenance work, modification work and test inspections work when no other locking opportunity than ice plugging is available.

The application of the ice plug isolation technique is principally not allowed on cladded pipes or pipes with internal coatings. The application for pressure test is not in the scope of this document and should be qualified separate.

This document specifies a method for the detection and identification of microalgae, macroalgae (seaweed), cyanobacteria and Labyrinthulomycetes by using morphological methods and/or molecular methods.

The morphological methods in this document are applicable to harvested wet biomass and to harvested dried unground biomass from microalgae, macroalgae, cyanobacteria and Labyrinthulomycetes that have been grown and/or harvested for further processing and/or use.

The molecular methods in this document are applicable to harvested wet biomass and to harvested dried and/or ground biomass from microalgae, macroalgae, cyanobacteria and Labyrinthulomycetes that have been grown and/or harvested for further processing and/or use.

This document describes a toolbox, consisting of several identification methods that can be chosen according to the applicability and purpose of the identification:

— morphological methods based on observation and referring to scientific literature on taxonomy:

— macroscopic observation;

— light microscopic observation;

— molecular methods of sequencing and blasting of sequences:

— 16S-rDNA sequencing;

— 18S-rDNA sequencing;

— rbcL DNA sequencing;

— ITS sequencing;

— COX 1 gene sequencing;

— tufA gene sequencing.

This document does not deal with genetic purity of the biomass or quantification of the identified taxa.

This International standard describes a protocol for the verification and validation of building fire

evacuation models. The present document mostly addresses evacuation model components as they are

in microscopic agent-based models. Nevertheless, the user of this protocol may adopt it (entirely or part

of it) for macroscopic models if the model is able to represent the components under consideration.

The area of application of the evacuation models discussed in this document includes performancebased

design of buildings and the review of the effectiveness of evacuation planning and procedures.

The evacuation process is represented with evacuation models in which people movement and their

interaction with the environment make use of human behaviour in fire theories and empirical

observations. The simulation of evacuation is represented using mathematical models and/or

agent-to-agent and agent-to-environment rules.

The area of application of this standard relates to buildings. This document is not intended to cover

aspects of transportation systems in motion (e.g. trains, ships) since specific ad-hoc additional tests may

be required for addressing the simulation of human behaviour during the evacuation in these types of

systems (Guillaume and Thiry-Muller, 2018).

This document includes a list of components for the verification and validation testing as well as a

methodology for the analysis and assessment of accuracy associated with evacuation models. The

procedure for the analysis of acceptance criteria is also included.

A comprehensive list of components for testing is presented in this document since the scope of the

testing has not been artificially restricted to a set of straightforward basic set of applications.

Nevertheless, the application of evacuation models as a design tool may be affected by the numbers of

variables affecting human behaviour under consideration. A high number of influences might hamper

the acceptance of the results obtained given the level of complexity associated with the results. Simpler

calculation methods such as macroscopic models, capacity analyses or flow calculations are affected to a

lower extent by the need to aim at high fidelity modelling. In contrast, more sophisticated calculation

methods (i.e. agent-based models) rely more on the ability to demonstrate that the simulation is able to

represent different emergent behaviours. For this reason, the components for testing are divided into

different categories so that the evacuation model tester can test an evacuation model both in relation to

the degree of sophistication embedded in the model as well as the specific scope of the model

application.

In Annex A, a reporting template is provided to provide guidance to users regarding a format for

presenting test results and exemplary application of verification and validation tests are presented

in Annex B.