Yhteinen Toimialaliitto

 

This document specifies the methodologies for calculation of braking performance for railway rolling stock. This document describes the general algorithms/formulae using instantaneous value inputs to perform calculations of brake equipment and braking performance, in terms of stopping/slowing distances, braking power and energy for all types of rolling stock, either as vehicles or units. The calculations can be performed at any stage of the assessment process (design, manufacture, testing, verification, investigation, etc.) of railway rolling stock. This document does not set out specific acceptance criteria (pass/fail). This document is not intended to be used as a design guide for the selection of brake subsystems and does not specify performance requirements. This document does not provide a method to calculate the extension of stopping distances when the level of demanded wheel/rail adhesion exceeds the available wheel/rail adhesion (wheel slide activity). This document contains examples of the calculation of braking forces for different brake equipment types and examples of the calculation of stopping distance for vehicles or units.

 

This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption, or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility.

 

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. 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 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE 1 See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance. ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use. ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

 

This document defines technical criteria and control procedures which are satisfied by hollow sleepers and bearers used in ballasted track with Vignole rails. The hollow sleepers and bearers designed for ballasted track can also be used in ballastless track. In this case, the requirements are defined by the customer.

 

This document defines a process guideline and a methodology to support the introduction of new materials and processes to meet the minimum requirements in the railway sector for all rolling stock defined in EN 17343 and onboard equipment. This document is applicable to new materials and processes for all rolling stock and onboard equipment.

 

ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.

 

This document specifies the requirements for the function, design, performance, and testing of emergency push buttons that are installed in train’s driving’s cab. This document is applicable for emergency push button. This document is not applicable for emergency handle.

 

This document specifies the information and communication technology (ICT) perspective requirements to manage the information of response resources for a public health emergency (PHE) response. The scope of the document includes: The requirements defined in this document can only be effectively applied, if information exchange described in clause 5 is supported at both municipal and national levels.

 

This document covers the following as a guideline: This document is applicable to HVAC units for the passenger area and driver’s cabs in urban (metro, tramway), suburban, regional and main line vehicles.

 

This document specifies contact tracing procedures for the highly contagious respiratory infectious disease cases including both symptomatic and asymptomatic infections for pandemic response. The scope of the document includes:

 

This document covers the following as a guideline: - the basic design parameters to be provided to the HVAC unit manufacturer by the rolling stock manufacturer and the railway operator; - the basic test/inspection items, requirements and methods used by the HVAC unit manufacturer.

 

 

ISO 15118-4:2018 specifies conformance tests in the form of an Abstract Test Suite (ATS) for a System Under Test (SUT) implementing an EVCC or SECC according to ISO 15118-2. These conformance tests specify the testing of capabilities and behaviors of an SUT as well as checking what is observed against the conformance requirements specified in ISO 15118-2 and against what the supplier states the SUT implementation's capabilities are. The capability tests within the ATS check that the observable capabilities of the SUT are in accordance with the static conformance requirements defined in ISO 15118-2. The behavior tests of the ATS examine an implementation as thoroughly as is practical over the full range of dynamic conformance requirements defined in ISO 15118-2 and within the capabilities of the SUT (see NOTE). A test architecture is described in correspondence to the ATS. The conformance test cases in this document are described leveraging this test architecture and are specified in TTCN-3 Core Language for ISO/OSI Network Layer (Layer 3) and above. The conformance test cases for the Data Link Layer (Layer 2) and Physical Layer (Layer 1) are described in ISO 15118-5. Test cases with overlapping scopes are explicitly detailed. This document does not include specific tests of other standards referenced within ISO 15118-2, e.g. IETF RFCs. Furthermore, the conformance tests specified in this document do not include the assessment of performance nor robustness or reliability of an implementation. They cannot provide judgments on the physical realization of abstract service primitives, how a system is implemented, how it provides any requested service, nor the environment of the protocol implementation. Furthermore, the test cases defined in this document only consider the communication protocol defined ISO 15118-2. Power flow between the EVSE and the EV is not considered. NOTE 1 Practical limitations make it impossible to define an exhaustive test suite, and economic considerations can restrict testing even further. Hence, the purpose of this document is to increase the probability that different implementations are able to interwork. This is achieved by verifying them by means of a protocol test suite, thereby increasing the confidence that each implementation conforms to the protocol specification. However, the specified protocol test suite cannot guarantee conformance to the specification since it detects errors rather than their absence. Thus conformance to a test suite alone cannot guarantee interworking. What it does do is give confidence that an implementation has the required capabilities and that its behavior conforms consistently in representative instances of communication. NOTE 2 This document has some interdependencies to the conformance tests defined in ISO 15118-5 which result from ISO/OSI cross layer dependencies in the underlying protocol specification (e.g. for sleep mode)

 

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied. NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

 

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

 

 

 

This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. NOTE           For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. This document specifies additional disclosure requirements. This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.

 

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: —   intended for use with patients who can breathe spontaneously; and —   intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1        In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: —   fully integrated ME equipment; or —   a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2  This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4         Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. 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 the general standard, 7.2.13 and 8.4.1. NOTE 3        Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: —    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601-2-12[14]; —    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[15]; —    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[20]; —    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[17]; —    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601-2-79[18]; —    ventilatory support equipment or accessories intended for patients with ven

 

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1         Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 1        Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601-1. NOTE 2        ISO 5367 specifies other safety and performance requirements for breathing tubes. This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE 3        A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE 2         Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12[10] also applies. EXAMPLE 3         Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[12] also applies. EXAMPLE 4         Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[11] also applies. EXAMPLE 5         Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply. EXAMPLE 6         Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601-2-90[15] also applies. This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE 4        ISO 9360-1 and ISO 9360-2[4] specify safety and performance requirements for a passive HME. NOTE 5        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+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6        Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6]. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This