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ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

 

This document specifies the general characteristics of grooved pins, made of steel and stainless steel, with nominal diameters 1 mm to 25 mm. These grooved pins are designed to fulfil the main following functions, due to the elastic fit behaviour of the grooves:

 

This part of ISO/IEC 80079 specifies the technical requirements for design, construction, conversion, testing, marking and the information required for use to avoid or minimise the possibility of ignition which could from reciprocating internal combustion engine intended for use in explosive atmospheres including: – Group I EPL Mb for use in underground workings susceptible to firedamp or combustible dust, – Group II EPL Gb and EPL Gc for use in explosive atmospheres of flammable gas and vapour, and – Group III EPL Db and EPL Dc for use in explosive atmospheres of combustible dust. – For EPL Gc and Dc engines, only normal operating conditions need to be taken into account. Malfunctions need not be considered (see B.2.1). This document includes those tests of the engine and its ancillary devices that are required to verify compliance with this document. This document applies to both reciprocating internal combustion engines with compression ignition for EPL Mb, Gb, Gc, Db, Dc and gaseous fuelled spark ignition engines for EPL Gc. See Annex G. This document does not define requirements relating to the driven machinery and equipment. This document does not apply to – explosive mixtures of vapours and gases, which tend to self-decompose (for example carbon disulphide (CS2), ethylene oxide (C2H4O), acetylene (C2H2)) or which are chemically unstable; • hydrogen fueled engines, including blends; • engines used in areas for the processing, manufacture or storage of explosives; • gasoline and other spark ignited engines where the fuel is injected into the combustion chamber as a liquid; or • electrical ignition spark systems. Note 1 Spark ignition systems used with equipment covered by ISO/IEC 80079-41 is covered by IEC 60079-45 This document solely deals with explosion protection requirements. Requirements on gaseous or particulate exhaust emissions are not covered by this standard. General safety requirements are not included in this International Standard. This document does not specify requirements for safety, other than those directly related to the possibility of ignition of flammable mixtures in the surrounding atmosphere which can lead to an explosion. The standard atmospheric conditions (relating to the explosion characteristics of the atmosphere) under which it can be assumed that the engine may be operated are: • temperature –20 °C to +60 °C • pressure 80 kPa (0,8 bar) to 110 kPa (1,1 bar); and • air with normal oxygen content, typically 21% v/v. An engine for use outside of the standard atmospheric conditions is to be designed, constructed tested and marked for those conditions. The ignition hazard assessment, ignition, protection provided, additional testing (if necessary) manufacturer’s technical documentation and instructions to the user are intended toclearly demonstrate the engine’s suitability for the conditions. NOTE 2 changes in temperature and pressure have an influence on the characteristics of the explosive atmosphere including ignitability NOTE 3 IEC TS 60079-43 gives information for equipment used in explosive atmospheres in environmental conditions which include ambient temperatures below –20 °C and additional adverse conditions, including maritime applications. NOTE 4 Reciprocating internal combustion engines are not considered as pressure vessels. This document supplements and modifies the general requirements of IEC 60079-0:2017 and ISO 80079-36. Where a requirement of this document conflicts with a requirement of IEC 60079-0:2017 and ISO 80079-36 as far as applicable for Ex engines, the requirement of this standard takes precedence. NOTE 5 On-going inspection, maintenance and repair aspects play an important role in control of hazardous area installations and the user’s attention is drawn to IEC 60079-17, IEC 60079-19 and IEC 60079-14 and manufacturer’s instructions for further information concerning these aspects.

 

This document provides a self-assessment of an organization’s human-centred design principles, processes, and activities throughout the life cycle of computer-based interactive systems, It also provides an overview of information given in the ISO 9241-200 series of standards. It is intended to be used as an introduction and self-assessment guide to human-centred design (HCD). Its target audience are personnel responsible for and managing design processes, and it is concerned with ways in which both hardware and software components of interactive systems can enhance human–system interaction. It includes a self-assessment that allows organizations to understand and assess their level of awareness and practices with respect to the human-centred design approach and best practices for organizations and project teams within that organization. This self-assessment is provided as a set of survey questions as well as assessment matrices. The survey may be used directly (answering the survey questions to perform an assessment) or by surveying a number of members of a project team or organization. The matrices may be used to report and visualize the results of the survey-based assessment, or as rapid assessments in their own right. This document does not provide detailed coverage of the methods and techniques required for human-centred design, nor does it address health or safety aspects in detail. Although it addresses the planning and management of human-centred design, it does not address all aspects of project management. The self-assessment matrices that can be used for organizations to assess their level of maturity and support claims of conformance are provided as informative Annexes.

 

This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging. This document applies to operating lights, irrespective of the technology of the light source. This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.

 

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

 

This document deals with whole body vibration as a significant hazard. It also specifies the methods for determining the vibration emission transmitted to the whole body of drivers standing and/or seated on freely moveable GSE, when driving for purposes of type evaluation, declaration and methods of verifying vibration emission. The test results are not applicable to the determination of whole body vibration exposure of persons.

 

ISO 14025:2006 establishes the principles and specifies the procedures for developing Type III environmental declaration programmes and Type III environmental declarations. It specifically establishes the use of the ISO 14040 series of standards in the development of Type III environmental declaration programmes and Type III environmental declarations. ISO 14025:2006 establishes principles for the use of environmental information, in addition to those given in ISO 14020:2000 Type III environmental declarations as described in ISO 14025:2006 are primarily intended for use in business-to-business communication, but their use in business-to-consumer communication under certain conditions is not precluded.

 

This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR). This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases. This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials. The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only. This document does not cover the step in which the user verifies a reagent (analysis method adoption). NOTE Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.

 

ISO/IEC 17024:2012 contains principles and requirements for a body certifying persons against specific requirements, and includes the development and maintenance of a certification scheme for persons.

 

 

This document contains principles and requirements for a body operating certification of persons and includes the development and maintenance of a scheme for certification of persons.

 

This European Standard specifies requirements for chemical and physical properties, and minimum performance requirements of low expansion foams suitable for surface application to water-immiscible liquids. Requirements are also given for marking. WARNING - Any type approval according to this standard is invalidated by any change in composition of the approved product. Some concentrates conforming to this part of EN 1568 can also conform to other parts and therefore can also be suitable for application as medium and/or high expansion foams, and for application at low expansion to water-miscible liquids.

 

This European Standard specifies requirements for chemical and physical properties, and minimum performance requirements of medium expansion foams suitable for surface application to water-immiscible liquids. Requirements are also given for marking. WARNING - Any type approval according to this standard is invalidated by any change in composition of the approved product. Some concentrates conforming to this part of EN 1568 can also conform to other parts and therefore can also be suitable for application as low and/or high expansion foams.

 

This European Standard specifies requirements for chemical and physical properties, and minimum performance requirements of high expansion foams suitable for surface application to water-immiscible liquids. Requirements are also given for marking. WARNING - Any type approval according to this standard is invalidated by any change in composition of the approved product. Some concentrates conforming to this part of EN 1568 can also conform to other parts and therefore can also be suitable for application as low and/or medium expansion foams.

 

This document specifies the requirements relating to: Steel GX5CrNiCuNb16-4 (1.4525) Homogenized Solution treated and precipitation hardened Investment casting De = 50 mm Rm = 900 MPa for aerospace applications.

 

This document specifies the requirements and test procedures for 360° visibility of self-propelled industrial rider-controlled pallet-stacking trucks in accordance with ISO 5053-1 (herein after referred to as trucks), without a load and it is intended to be used in conjunction with EN 16842-1. This document also applies to pedestrian controlled trucks with foldable platform when used in ride-on mode. Pedestrian-controlled and pedestrian-propelled trucks are not covered by this document. Where specific requirements in this part are modified from the general requirements in EN 16842-1, the requirements of this part are truck specific and intended to be used for self-propelled industrial stand-on pallet-stacking trucks. This part of EN 16842 deals with all significant hazards, hazardous situations or hazardous events relevant to the visibility of the operator for applicable machines when used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.

 

This document specifies the technical requirements of rectangular connectors with sealed and non-sealed rear, plastic housing, locking device, for operating temperatures from -55 °C to 175 °C.