Yhteinen Toimialaliitto

 

1.1 This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. 1.2 This document specifies minimum requirements: - for the performance and design of sterilizers intended to deliver an LTSF-process capable of sterilizing medical devices; - for the equipment and controls of these sterilizers needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process. 1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document. 1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

 

This document gives design rules and requirements in order to ensure proper access, lighting, seating and exit of driver's cabs. The different dimensions are based on the anthropometric data defined in EN 16186-5. The corresponding assessment methods are also included in this document. It covers the following aspects: — dimension and interior layout; — door access, steps, floor characteristics; — seats dimension and clearance; — interior cab lighting; — emergency exit; — marking and labelling. This document is applicable to vehicles operating on tram networks.

 

 

This document applies to printed, projected, and electronic displays of high-contrast text that are designed for assessment and measurement of near reading acuity under photopic conditions The definitions and requirements of this document apply to the Latin alphabet.

 

This document provides requirements for label information about chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on extraction media, methods of extraction and quantitative assay of residual chemicals. This document does not provide information on the allergenic potential or safety to the user of any product. This is expected to be assessed in the light of all available toxicity and biocompatibility data on the products concerned as part of a risk management process.

 

 

 

This International Standard applies to displays of high-contrast text that are designed for general near vision assessment. It does not apply to measurement systems designed for specialized testing of near visual acuity, e.g., low vision or low contrast charts or those intended for transillumination, or electronically generated systems.

 

 

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. The requirements specified in this document are applicable in conjunction with the general requirements specified in ISO/DIS 15883-1:2020. The specified performance requirements of this document might not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

 

This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. The requirements of this document apply in addition to the general requirements specified in ISO/DIS 15883-1:2020 and ISO 15883-5:2021.

 

This document specifies the determination of the share of material recovery in the case of energy recovery (i.e. co-processing) of SRF, i.a., in a cement kiln. This share, called Recycling Index, is calculated on the basis of the ash content and the ash composition.

 

This document only applies to continuous testing of rails installed in track for detecting internal discontinuities. This document only applies to testing equipment fitted to dedicated test vehicles or manually-propelled devices. This document treats welded joints as plain rail. This document does not define the requirements for vehicle acceptance. This document does not apply to ultrasonic testing of rails in a production plant. This document specifies the requirements for testing principles and systems in order to produce comparable results with regard to location, type and size of discontinuities in rails. This document is not aiming to give any guidelines for managing the result of ultrasonic rail testing. This document only applies to flat bottom (Vignole) railway rail profile 43 kg/m and above.

 

This document specifies a method for the determination of the share of material recovery in the case of co-incineration of SRF in a cement kiln. SRF contain inert mineral materials such as SiO2, CaO, etc, which are required for the production of cement clinker. When co-processed in the cement industry, the contained energy is recovered and the mineral part of SRF is incorporated into the clinker. On the basis of the ash content and the ash composition the Recycling-Index can be calculated.

 

ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1. The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

 

ISO 15883-3:2006 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.

 

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This document does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665. This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

 

This document specifies safety requirements relevant to certain aspects of the design and construction of classified pools according to Clause 4. It is intended for those concerned with the design, construction, planning and operation of classified swimming pools. It provides guidance about the risks associated by identifying the design characteristics required for a safe environment. The requirements of this document are applicable to all new classified pools and, as appropriate, to specific refurbishments of classified existing pools. This document has limited application to classified pools which consist of segregated areas of rivers, lakes or the sea but this document should be followed where relevant. National and/or local legislation may apply. This document is not applicable to domestic swimming pools according to EN 16582 (all parts). Further definitions of domestic swimming pools and/or use is given in EN 16582.

 

This document specifies general safety requirements and test methods for equipment installed in swimming pools for public use as classified in EN 15288 1 and EN 15288 2. Where specific standards exist, this general standard is not expected to be used alone. Special care is expected to be taken in applying this general standard alone to equipment for which no product specific standard has yet been published.

 

This document is applicable to rail vehicles and specifies the terms, definitions, symbols and abbreviated terms to be used in the ISO 19659 series, heating, ventilation and air conditioning for rolling stock.