Toimialayhteisöt

 

This document provides requirements and guidelines for the application of the book and claim chain of custody model. It is applicable to any flow of materials or products or processes within a system, including how to attribute specified characteristics to flows of such processes. This document provides requirements and guidelines for the following matters, amongst others:

 

This document provides requirements and guidelines for the application of the mass balance chain of custody model, as defined in ISO 22095, to any material or product flow within mass balance systems, including how to attribute specified characteristics to flows of such processes. This document provides requirements and guidelines for the following matters, amongst others:

 

This document specifies definitions and general requirements for cell viability analytical methods and for reporting cell viability. It provides general considerations for selecting and establishing fit-for-purpose cell viability analytical methods. It provides requirements for establishing standard operating procedures for cell viability analytical methods. It also provides considerations for managing sources of variability for cell viability measurements during pre-analytical, analytical, and post-analytical phases. This document is applicable to cells in suspension, cells adhered to a substrate, and cells in complex matrices. This document is primarily applicable to cell viability measurements of nucleated mammalian cells.

 

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s). It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard. ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care. It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected. ISO 27799:2016 and ISO/IEC 27002 taken together define what is required in terms of information security in healthcare, they do not define how these requirements are to be met. That is to say, to the fullest extent possible, ISO 27799:2016 is technology-neutral. Neutrality with respect to implementing technologies is an important feature. Security technology is still undergoing rapid development and the pace of that change is now measured in months rather than years. By contrast, while subject to periodic review, International Standards are expected on the whole to remain valid for years. Just as importantly, technological neutrality leaves vendors and service providers free to suggest new or developing technologies that meet the necessary requirements that ISO 27799:2016 describes. As noted in the introduction, familiarity with ISO/IEC 27002 is indispensable to an understanding of ISO 27799:2016. The following areas of information security are outside the scope of ISO 27799:2016: a) methodologies and statistical tests for effective anonymization of personal health information; b) methodologies for pseudonymization of personal health information (see Bibliography for a brief description of a Technical Specification that deals specifically with this topic); c) network quality of service and methods for measuring availability of networks used for health informatics; d) data quality (as distinct from data integrity).

 

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This document provides a set of information security controls, including implementation guidance, for health organizations. It is based on ISO/IEC 27002:2022. In addition to generic ICT equipment and software used in many other environments, the scope of this document includes software and systems specifically for healthcare, such as electronic health record systems and medical devices incorporating health software. Such medical devices can be programmed or programmable and can contain software, firmware or both. Also in scope is other digital equipment (such as that for environmental and infection control, building management, and physical security) that can be used in premises where healthcare is provided. This document applies to health and other relevant information in all its aspects, whatever form the information takes (including text and numbers, sound recordings, drawings, images and video), by whatever means it has been acquired or captured, whatever means are used to store it (such as printing or writing on paper or storage electronically), and whatever means are used to transfer or exchange it (orally, by hand, by post, movement of storage media, direct links or networking). This document is for organizations of all types and sizes that provide healthcare or are custodians of personal health information for other reasons. The information that they are responsible for can be stored and processed in many possible ways and locations, including on premises or in the cloud, but remains in scope. This document applies to all physical settings where healthcare is intended to be delivered, such as hospitals, clinics and other locations or facilities designated for healthcare purposes such as ambulances and mobile imaging or diagnostic units. It also applies to care provided elsewhere, such as in residential premises. In addition to the range of settings, this document applies to all methods of service provision including remote or virtual healthcare.

 

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— yhdenmukaistaminen ISO/IEC 27002:2022 -standardin uuden rakenteen ja siihen tehtyjen muutosten kanssa verrattuna edelliseen versioon
— terveydenhuoltoon liittyvien hallintakeinojen tarkistus ja lisäys
— sellaisten sisältöjen poistaminen, jotka sisältyvät ISO/IEC 27002:2022 -standardiin, mutta eivät olleet sen aiemmassa versiossa
— informatiivisten liitteiden lisääminen, jotka sisältävät

 

 

 

 

This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD. The range of products on which WD of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

 

This Recommendation | International Standard gives guidelines for information security controls applicable to the provision and use of cloud services by providing: This Recommendation | International Standard provides controls and guidance for CSCs and CSPs. This Recommendation | International Standard excludes any and all aspects of conformity assessment.

 

This document specifies an ageing method for phosphate ester turbine control fluids. These products fall into category HFDR of ISO 6743-4[1] and into categories TSD, TGD and TCD of ISO 6743-5.[2] The amount of acid developed during the test are used to assess the level of anti-aging performance. The standard includes apparatus, reagents & materials, sampling, preparations, test methods, calculation, reports etc. This document is applicable to anti-ageing performance determination for phosphate ester turbine control fluids both new and in-service. This document does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

 

This document specifies a framework for representing data recorded in terminological data collections (TDCs). This framework includes a metamodel and methods for describing specific terminological markup languages (TMLs), exemplified in this document in eXtensible Markup Language (XML). The mechanisms for implementing constraints in a TML are defined, but not the specific constraints for individual TMLs. This document is designed to support the development and use of computer applications for terminological data and the exchange of such data between different applications. This document also defines the conditions that allow the data expressed in one TML to be mapped onto another TML.

 

 

This part of ISO 13347 applies to fans as defined in ISO 5801 and ISO 13349. It is limited to the determination of airborne sound emission for the specified set-ups. Vibration is not measured, nor is the sensitivity of airborne sound emission to vibration effects determined. The sizes of fan which can be tested in accordance with this part of ISO 13347 are limited only by the practical aspects of the test set-up. Dimensional limitations, test fan dimensions, and air performance will control the room size, power and mounting requirements for the test fan. (Small fans may be tested according to this part of ISO 13347 or to ISO 10302, according to usage). The test arrangements in this part of ISO 13347 establish the laboratory conditions necessary for a successful test. Rarely will it be possible to meet these requirements in situ and this part of ISO 13347 is not intended for field measurements. Intending users are reminded that, in these situations, there may well be additional acoustic system effects where inlet and outlet conditions at the fan are less than ideal. The enveloping surface methods may be used for the determination of open inlet and/or open outlet sound power level of fans for the standardized installation category’s given in 3.1. An estimation (with increased uncertainty) of ducted sound power for fans too small, or otherwise inconvenient, for testing by the in-duct method described in ISO 5136 may also be obtained by the addition of end reflection corrections (see Annex C of ISO 13347-1).

 

This part of ISO 11228 establishes ergonomic recommendations for repetitive work tasks involving repetitive movements and exertions of the upper extremity. It provides guidance on the identification and assessment of risk factors commonly associated with repetitive movements and exertions of the upper limbs, thereby allowing evaluation of the related health risks to the working population. The recommendations apply to the adult working population and are intended to give reasonable protection for nearly all healthy adults. Those recommendations concerning health risks and control measures are mainly based on research involving in North American and European populations and how work methods affect musculoskeletal loading, discomfort/pain and endurance/fatigue. These recommendations can be used for guidance purposes. Countries may generate their own recommendations based on studies on native populations. For the evaluation of working postures, refer to ISO 11226. It should be noted that this standard does not have a mass threshold or limit. However, if the masses handled are 3 kg or more, the user is directed to also consult ISO 11228-1 Ergonomics – Manual handling – Part 1: Lifting, lowering and carrying. This part of ISO 11228 is intended to provide information for all those involved in the design or redesign of work, jobs and products (e.g. machinery). This document does not address the manual handling of objects while using lift-assistive devices such as exoskeletons and does not address the needs of pregnant women or persons with disabilities.

 

This document specifies a method for evaluation of the ductility of the fusion joint interface of assemblies of polyethylene (PE) pipe and electrofusion saddles, intended for the conveyance of fluids.

 

This document specifies a micrographic method of determining the non-metallic inclusions in rolled or forged steel products having a reduction ratio of at least 3 using standard reference chart or direct measurement by image analysis technologies. This method is widely used to assess the suitability of a steel product for a given use. However, since it is difficult to achieve reproducible results owing to the distributional randomness of non-metallic inclusion, even with a large number of specimens, precautions should be taken when using the method.

 

This document specifies requirements for the machine manufacturer for preparation of the safety-relevant parts of an instruction handbook for machinery. This document: — provides further specifications to the general requirements on information for use given in ISO 12100:2010, 6.4.5; and — deals with the safety-related content, the corresponding structure and presentation of the instruction handbook, taking into account all phases of the life cycle of the machine. NOTE 1 The strategy for risk reduction at the machine is given in ISO 12100:2010, Clause 6, and includes inherently safe design measures, safeguarding and complementary risk reduction measures as well as information for use. NOTE 2 Annex A contains a correspondence table between ISO 12100:2010, 6.4, and this document. NOTE 3 Information for conception and preparation of instructions in general is available in IEC/IEEE 82079-1. This document establishes the principles which are indispensable to provide information on residual risks. This document does not address requirements for declaration of noise and vibration emissions. This document is not applicable to machinery manufactured before the date of its publication.

 

ISO 19630:2017 specifies the conditions for the determination of tensile properties of single filaments of ceramic fibre such as tensile strength, Young modulus and fracture strain. The method applies to continuous ceramic filaments taken from tows, yarns, braids and knittings, which have strain to fracture less than or equal to 5 %. The method does not apply to carbon fibres that exhibit nonlinear stress-strain curve. The method does not apply to checking the homogeneity of strength properties of fibres, nor to assessing the effects of volume under stress. Statistical aspects of filament failure are not included.

 

ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.