Helsevesen, teknikk

1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. 1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT. 1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes. NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.

This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use in professional healthcare facilities; - intended for use by a lay operator or a healthcare professional operator; - intended for use with patients who can breathe spontaneously; - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. - not intended for patients who are dependent on artificial ventilation for their life support. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. Ventilatory high-flow therapy equipment is typically composed of four parts: 1) gas sources, - air, and - if needed, oxygen; NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air. 2) humidifier; NOTE 3 When dry gas is utilized, a humidifier is typically needed. 3) breathing tube; 4) a patient interface, which is used to deliver gas to the patient; and 5) a flow controller, which is used to select and deliver the desired flow. NOTE 4 The flow controller can be at a fixed rate. NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates). These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy. Ventilatory 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 ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. 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; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72; - ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79; - ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80; - sleep apnoea therapy ME equipment, which are given in ISO 80601 2 70; - continuous positive airway pressure (CPAP) ME equipment; - high-frequency jet ventilators (HFJVs); - high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and - cuirass or "iron-lung" ventilation equipment. NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes. This docum.....

This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard. This European Standard also specifies terms and definitions which are used in European Standards. It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages). It is intended to: a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product; b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product; c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market. It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas. In the area of human medicine (Working Group 1, i. e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care — in hospitals, in community medical facilities and dental institutions, — in clinics of schools, of kindergartens and of nursing homes, — and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient. In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry. In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, pharmaceutical, cosmetic etc. industries. This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified. This standard will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards should be used, even if they are not yet mentioned in EN 14885. This European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.