Yhteinen Toimialaliitto

 

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

 

 

 

 

 

 

ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

 

 

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601-2-80[11].

 

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

 

This document defines terms within the field of electronic fee collection (EFC). This document defines: — terms within the fields of electronic fee collection and road user charging; — terms that are used in standards related to electronic fee collection; — terms of a more general use that are used more specifically in standards related to electronic fee collection. This document does not define: — Terms related primarily to other fields that operate in conjunction with EFC, such as terms for intelligent transport systems (ITS), common payment systems, the financial sector, etc. — Deprecated terms.

 

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas. This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to "use recommendations". NOTE This method corresponds to a phase 2 step 1 test.

 

This document specifies methods of determining the luminous and solar characteristics of glazing in buildings. These characteristics can serve as a basis for lighting, heating and cooling calculations of rooms and permit comparison between different types of glazing. This document applies both to conventional glazing and to absorbing or reflecting solar-control glazing, used as vertical or horizontal glazed apertures. The appropriate formulae for single, double and triple glazing are given. A matrix method is provided as an alternative calculation method. This document introduces a method to determine the luminous and solar properties of Building-Integrated Photovoltaic (BIPV) glazing. This document is accordingly applicable to all transparent materials except those which show significant transmission in the wavelength region 5 µm to 50 µm of ambient temperature radiation, such as certain plastic materials. Materials with light-scattering properties for incident radiation are dealt with as conventional transparent materials subject to certain conditions (see 5.2). Angular light and solar properties of glass in building are excluded from this document. However, research work in this area is summarized in Bibliographic references [1], [2] and [3]. Guidance on the measurement of luminous and spectral properties of glass can be found in the Bibliography [4]. Vacuum Insulating Glass (VIG) is excluded from the scope of this document. For determination of the g value of VIG, please refer to ISO 19916-1.

 

This document contains procedures for performance testing of electrical terminals, connectors, and components for coaxial-style cable with an outside cable diameter of 3,6 mm and smaller. These are often called mini coaxial connector systems. This document applies to coaxial cable connection systems that operate at frequencies from DC to up to 9 GHz and are intended for road vehicles. The characteristic impedance of the mini-coax connection system described here is 50 O, however nothing excludes the use of these connectors in systems with a different characteristic impedance. This document applies only to connection systems using coaxial cable. This document is intended to assess a connector with the same pass/fail outcome as Reference [1] would produce. Users are encouraged to consider using existing design interfaces. Examples of existing design interfaces, both water sealed and unsealed, are identified in Annex F.