Palvelualojen työnantajat PALTA

 

This document specifies, principles and a process for the clinical evaluation of medical devices. This document specifies how to plan and perform clinical evaluation, including the collection, appraisal and analysis of data to assess the safety and, clinical performance or effectiveness, including clinical benefit(s) of medical devices, and to evaluate the acceptability of clinical risks when weighed against the clinical benefits achieved when the device under evaluation (DUE) is used as intended by the manufacturer. This includes the determination whether there is evidence for the assessment. This document also: — defines the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer, — assists manufacturers, regulatory authorities and other stakeholders involved in the process or assessment of the clinical evaluation of medical devices and, — provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions. This document does not apply to in vitro diagnostic medical devices. NOTE 1 National regulations can have additional or different requirements. NOTE 2 Some of the principles of this document can apply to actors other than manufacturers involved in clinical evidence generation.

 

This part of ISO 17536 specifies general conditions, defines terms and establishes the basic principles for blowby oil aerosol separator performance tests by laboratory or engine and gravimetric or fractional test method. Conformance of a device to legislation is outside of the scope of this standard and the appropriate regulations must be consulted.

 

 

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment. Me equipment that measures a body temperature is inside the scope of this document. ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601-2-59[4]. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

 

This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended. The requirements of this document are applicable throughout the life cycle of a medical device. The process described in this document applies to the assessment of risks and benefits from clinical data obtained from the use of medical devices in humans. This document specifies general requirements intended to — verify the safety of medical devices when used in accordance with their instructions for use; — verify that the clinical performance or effectiveness of a medical device meet the claims of the manufacturer in relation to its intended use; — verify that there is sufficient clinical evidence to demonstrate the achievement of a positive benefit/risk balance when a medical device is used in the intended patient population in accordance with its intended use; — ensure the scientific conduct of a clinical evaluation and the credibility of conclusions drawn on the safety and performance of a medical device; — define the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation; and — assist manufacturers, clinicians, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Note 1 This standard can be used for regulatory purposes. Note 2 This document does not apply to in vitro diagnostic medical devices. However, there may be situations, dependent on the device and national or regional requirements, where sections and/or requirements of this document might be applicable.

 

This document specifies the test procedures for roadside equipment (RSE) and on-board equipment (OBE) for electronic fee collection (EFC) with regard to the conformance to standards and requirements for type approval and acceptance testing. The scope of this document is restricted to systems operating within the radio emission, electromagnetic compatibility (EMC) regulations, traffic, and other regulations of the countries in which they are operated. This document identifies a set of suitable parameters and provides test procedures to enable the proof of a complete EFC system, as well as components of an EFC system, e.g. OBE, related to the defined requirements of an application. The defined parameter and tests are assigned to the following groups of parameters: — functionality; — quality; — referenced pre-tests. This document describes procedures, methods and tools, and a test plan which shows the relation between all tests and the sequence of these tests. It lists all tests that are required to measure the performance of EFC equipment. It describes which EFC equipment is covered by the test procedures; the values of the parameters to be tested are not included. It also describes how the tests are to be performed, and which tools and prerequisites are necessary before this series of tests can be undertaken. It is assumed that the security of the system is inherent in the communications and EFC functionality tests, therefore they are not addressed here. All tests in this document provide instructions to how to evaluate the test results. This document defines only the tests and test procedures, not the benchmark figures that these are to be measured against. The test procedures defined in this document can be used as input, e.g. by scheme owners, for prototype testing, type approvals, tests of installations and periodic inspections. Related to a conceptual model of an EFC system, this document relates only to the equipment of the user and the service provider. EFC systems for dedicated short-range communication (DSRC) consist, in principle, of a group of technical components, which in combination fulfil the functions required for the collection of fees by electronic automatic means. These components comprise all, or most, of the following: — OBE within a vehicle; — OBE containing the communications and computing sub-functions; — optional integrated circuit card which may carry electronic money, service rights, and other secured information; — communication between OBE and RSE based on DSRC; — equipment for the fee collection at the RSE containing the communications and computing sub-functions; — equipment for the enforcement at the roadside; — central equipment for the administration and operation of the system. The scope of this document relates solely to OBE and RSE and the DSRC interface between OBE and RSE including its functions to perform the fee collection. All the equipment used for enforcement (e.g. detection, classification, localization, and registration) and central equipment are outside the scope of this document.

 

This document specifies the test procedures of electronic fee collection (EFC) roadside equipment (RSE) and on-board equipment (OBE) with regard to the conformance to standards and requirements for type approval and acceptance testing which is within the realm of EFC application specifically. The scope of this document is restricted to systems operating within the radio emission, electromagnetic compatibility (EMC) regulations, traffic, and other regulations of the countries in which they are operated. This document identifies a set of suitable parameters and provides test procedures to enable the proof of a complete EFC system, as well as components of an EFC system, e.g. OBE, related to the defined requirements of an application. The defined parameter and tests are assigned to the following groups of parameters: — functionality; — quality; — referenced pre-tests. An overview of the tests and parameters provided by this document is given in 5.1 and 5.2. This document describes procedures, methods and tools, and a test plan which shows the relation between all tests and the sequence of these tests. It lists all tests that are required to measure the performance of EFC equipment. It describes which EFC equipment is covered by the test procedures; the values of the parameters to be tested are not included. It also describes how the tests are to be performed and which tools and prerequisites are necessary before this series of tests can be undertaken. It is assumed that the security of the system is inherent in the communications and EFC functionality tests, therefore they are not addressed here. All tests in this document provide instructions to evaluate the test results. This document defines only the tests and test procedures, not the benchmark figures that these are to be measured against. The test procedures defined in this document can be used as input, e.g. by scheme owners, for prototype testing, type approvals, tests of installations and periodic inspections. Related to a conceptual model of an EFC system, this document relates only to the equipment of the user and the service provider. Any other entities are outside the scope of document. EFC systems for dedicated short-range communication (DSRC) consist, in principle, of a group of technical components, which in combination fulfil the functions required for the collection of fees by electronic automatic means. These components comprise all, or most, of the following: — OBE within a vehicle; — OBE containing the communications and computing sub-functions; — optional integrated circuit card which may carry electronic money, service rights, and other secured information; — communication between OBE and RSE based on DSRC; — equipment for the fee collection at the RSE containing the communications and computing sub-functions; — equipment for the enforcement at the roadside; — central equipment for the administration and operation of the system. The scope of this document relates solely to OBE and RSE and the DSRC interface between OBE and RSE including its functions to perform the fee collection. All the equipment used for enforcement (e.g. detection, classification, localization, and registration) and central equipment are outside the scope of this document.

 

This document specifies the dimensional requirements of end-connections for high-pressure fuel injection equipment components, used on diesel (compression-ignition) engines. It is applicable to externally threaded 60° concave cones (see Figures 1, 2, 5, and 6) and intended for use with high-pressure fuel injection pipe assemblies with tube outside diameters of: — up to and including 12 mm for integral concave cones (see Table 1); and — up to and including 9 mm for fabricated concave cones (see Table 2). Details of the pipe connection ends referenced in this document are shown in ISO 13296.

 

 

 

This document defines the architecture of electronic fee collection (EFC) system environments, in which a customer with one contract may use a vehicle in a variety of toll domains with a different toll charger for each domain. EFC systems conforming to this document can be used for various purposes including road (network) tolling, area tolling, collecting fees for the usage of bridges, tunnels, ferries, for access or for parking. From a technical point of view the considered toll systems may identify vehicles subject to tolling by means of electronic equipment on-board in a vehicle or by other means (e.g. automatic number plate recognition, ANPR). From a process point of view the architectural description focuses on toll determination, toll charging, and the associated enforcement measures. The actual collection of the toll, i.e. collecting payments, is outside of the scope of this document. The architecture in this document is defined with no more details than required for an overall overview, a common language, an identification of the need for and interactions among other standards, and the drafting of these standards. This document as a whole provides: — the enterprise view on the architecture, which is concerned with the purpose, scope and policies governing the activities of the specified system within the organization of which it is a part; — the terms and definitions for common use in an EFC environment; — a decomposition of the EFC systems environment into its main enterprise objects; — the roles and responsibilities of the main actors. This document does not impose that all roles perform all indicated responsibilities. It should also be clear that the responsibilities of a role may be shared between two or more actors. Mandating the performance of certain responsibilities is the task of standards derived from this architecture; — identification of the provided services by means of action diagrams that underline the needed standardised exchanges; — identification of the interoperability interfaces for EFC systems, in specialised standards (specified or to be specified).

 

 

As a Level 4 sub-trip feature (as defined in ISO TS 22736), HMCS performs the entire dynamic driving task (DDT) on the portion of a trip on an access-restricted motorway that satisfies its operational design domain (ODD) constraints. On approaching ODD boundaries HMCS prepares the user to re-engage in the DDT. If the user fails to take over, HMCS performs a minimal risk maneuver (MRM). This document defines the minimum functional requirements and test procedures for HMCS. HMCS can be featured in different forms or allow different non-driving related tasks. This document refers to the ISO 23792-x set of standards for the required driving performance in reference to the designed maneuvers and to the ISO 23793-x set of standards for minimum requirements with regard to the execution of MRM. This document applies to HMCS installed in light-duty vehicles.

 

This document specifies material and performance requirements and test methods for knives with metal blades intended for use in the preparation of food in household or commercial kitchens as well as in slaughtering facilities. This document does not apply for hunting knives, pocket knives, razors, utility or tool knives (with trapezoidal blade for cutting carpets etc.). This document does not apply for ceramic knifes, which are covered by ISO 8442-9.

 

This document specifies a reverberation chamber method for testing the immunity (off vehicle radiation source) of electronic components for passenger cars and commercial vehicles regardless of the propulsion system (e.g. spark-ignition engine, diesel engine, electric motor). The device under test (DUT), together with the wiring harness (prototype or standard test harness), is subjected to an electromagnetic disturbance generated inside a reverberation chamber, with peripheral devices either inside or outside the enclosure. It is applicable only to disturbances from continuous narrowband electromagnetic fields. See iso:proj:83225ISO 11452-1:2025 for general test conditions. General background information about the reverberation chamber test methods can be found in MIL-STD-461:2015 [1], [2], [3], [4], [5], [6], [7], [8]. Function performance status classification guidelines for immunity to electromagnetic radiation from an off-vehicle radiation source are given in Annex A.

 

This document defines the most commonly used terms for piston rings. These terms designate either types of piston rings or certain characteristics and phenomena of piston rings. The terms and definitions in this document apply to piston rings for reciprocating internal combustion engines. They may also be used for piston rings of compressors working under analogous conditions. NOTE 1 Further terms and definitions covering measuring principles are given in ISO 6621-2:2003 NOTE 2 This document gives the equivalent terms in the Chinese, English, French, German, Italian, Japanese, Portuguese, Russian and Spanish language.

 

This document specifies safety requirements for stationary exercise bicycles and upper body crank training equipment in addition to the general safety requirements of ISO 20957-1. This document is applicable to stationary training equipment type stationary exercise bicycles and upper body crank training equipment (type 5) as defined in Clause 3 within the classes S, H, I and A, B, C according to ISO 20957-1. Any attachment provided with the stationary exercise bicycles and upper body crank training equipment for the performance of additional exercises are subject to the requirements of ISO 20957-1. This document is not applicable to roller stands as they cannot be made safe in a reasonable way.

 

This document specifies safety requirements for exercise bicycles with a fixed wheel or without freewheel that have an inertia of >0,6 kg·m2. The requirements are in addition to the general safety requirements of ISO 20957-1, with which ISO 20957-10 is intended to be read in conjunction. Any attachment provided with the exercise bicycle with a fixed wheel or without a freewheel for the performance of additional exercises is subject to the requirements of ISO 20957-1.

 

This document defines the architecture of electronic fee collection (EFC) system environments, in which a customer with one contract can use a vehicle in a variety of toll domains with a different toll charger (TC) for each domain. EFC systems conforming to this document can be used for various purposes including road (network) tolling, area tolling, collecting fees for the usage of bridges, tunnels, ferries, for access or for parking. From a technical point of view the considered toll systems can identify vehicles subject to tolling by means of electronic OBE in a vehicle or by other means that are image-based (e.g. automatic number plate recognition, ANPR). From a process point of view the architectural description focuses on toll determination, toll charging, provision of toll service to the user, and the associated enforcement measures. The actual collection of the toll, i.e. collecting payments, is outside of the scope of this document. The architecture in this document is defined with no more details than required for an overall overview, a common language, an identification of the need for and interactions among other standards, and the drafting of these standards. This document as a whole provides: the enterprise view on the architecture, which is concerned with the purpose, scope and policies governing the activities of the specified system within the organization of which it is a part; — the terms and definitions specific to this standard, in addition to those provided in iso:proj:89981ISO/FDIS 17573-2; — a decomposition of the EFC systems environment into its main enterprise objects; — the roles and responsibilities of the main actors. This document does not impose that all roles perform all indicated responsibilities. It should also be clear that the responsibilities of a role can be shared between two or more actors. Mandating the performance of certain responsibilities is the task of standards derived from this architecture; — identification of the provided services by means of action diagrams that underline the needed standardized exchanges; — identification of the interoperability interfaces for EFC systems, in specialized standards.

 

This document specifies the sharpness and wear resistance of knives, which are designed for professional and domestic use in the preparation of food of all kinds, specifically of those knives intended for hand use. This document describes test methods for sharpness measurement and for the evaluation of wear resistance of the cutting edge. This document does not apply for hunting knives, pocket knives, razors or tool or utility knives (with trapezoidal blade for cutting carpets etc.). Knives with special shapes, e.g. herb chopping knives or highly curved boning knives, can only be tested in the style of this document since not all properties and test methods are applicable in a meaningful manner.