Palvelualojen työnantajat PALTA

 

This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, product marking, and manufacturer instructions for use. This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.

 

This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, product marking, and instructions for use provided by the manufacturer. These materials may also be used for maxillofacial prostheses. This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.

 

This document specifies methods for comparing computer simulation results, generated from a vehicle mathematical model, with measured test data obtained according to ISO 13674-1. The purpose of this comparison is to validate the simulation tool's accuracy in predicting vehicle behaviour for this specific test, enabling its application to one and more vehicle configuration. Extending this validation to further vehicle configurations and variants is outside the scope of this document. It is applicable to passenger cars as defined in ISO 3833.

 

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

 

This document is applicable to coil springs for use in orthodontic appliances. This document is not applicable to the devices that are composed by two or more coil springs. This document gives details of methods to compare the physical and mechanical properties of coil springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

 

Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting. This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories. NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards. NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs. Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.

 

This document is applicable to biology, chemistry and physics laboratories where research, preparative, analytical, process activities take place and which can involve work with hazardous substances, including higher education (college and university teaching and post-graduate research). This document does not cover the requirements of schools, i.e. precollege/pre-university (refer to EN 13150), or highly specialist laboratories which need very specific, bespoke solutions to enable them to function. This document specifies requirements for various types of services distribution carriers typically used in combination with laboratory bench types as covered in the EN 14056 series. This document gives guidelines for all parties involved in the planning, design, manufacture, installation, testing of a new laboratory or in the refurbishment of an existing laboratory.

 

This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. These materials may also be used for maxillofacial prostheses. This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.

 

This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.

 

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

 

This document specifies the requirements and tests for moist heat sterilizers intended to be used for the terminal sterilization of batch produced health care products presented as aqueous liquid in sealed containers. The aqueous liquid which the sterilizer is designed to process can be: a) liquid water or solutions in which a solute is dissolved; b) suspensions in which solid particles are suspended in an aqueous solvent; c) oil in water emulsions in which oil droplets are suspended in an aqueous solvent. The container which the sterilizer is designed to process can be rigid, semi rigid, or flexible and constructed from, for example, glass or polymeric materials. The sterilizer is designed to operate with a moist heat heating medium introduced into or created within the chamber, which can consist of: 1. saturated steam; 2. non-saturated steam; 3. a mixture of steam and pressurized water spray; or 4. water immersion. An over pressurising non-condensable gas such as air or nitrogen introduced into the chamber can be used to prevent container deformation or bursting and protect the integrity of the container closure system for steam-air mixtures, heated water as a spray or water immersion processes. This document applies to sterilizers designed to allow the load to remain static throughout the sterilization cycle and sterilizers that have a means by which the load is mechanically agitated by, for example, shaking or rotation. The sterilizer can be used in a health care facility or an industrial setting. The reference loads described in this document are representative of a small load of low thermal capacity and a large load of high thermal capacity which can be used for establishing the basic performance of the sterilizer. The performance of the sterilizer when processing production loads will be established during validation using specified loads. Requirements for the development, validation and routine control of moist heat sterilization processes is described in ISO 17665. This document is intended for sterilizers which are designed to process a defined load of product and not for those which are designed to sterilize a continuous flow of product through a processing environment. Sterilizers conforming with this document can also be used for the sterilization of veterinary products. Sterilizers conforming with this document can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the ISO 11607 series. This document is not intended to be retrospectively applied to pre-existing sterilizer equipment. NOTE 1 The sterilizing agent, moist heat, is produced within the contained product by use of a heating medium. NOTE 2 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by other standards, e.g. EN 285, EN 13060, ANSI/AAMI ST8, ANSI/AAMI ST55, JIS T 7322 and JIS T 7324. Some moist heat / steam sterilizers can be designed to provide both saturated steam sterilization processes and contained fluid sterilization processes.

 

This document specifies a classification framework and terminology of simulation models for perception sensors in Advanced Driver Assistance Systems and Automated Driving (ADAS/AD) use cases. It builds upon the overall framework defined in iso:proj:75910ISO 11010-1:2022, which is applicable to vehicle dynamic models. This document focuses on perception sensor models for radar, camera, lidar and ultrasonic. This document enables a structured approach for perception sensor model selection and provides a foundation for consistent sensor model comparison. The model classification is based on the modelling approach of the sensor model and its environment as well as the necessary inputs and outputs of the model.

 

This document sets out the technical requirements and mechanical performance for passenger seats that are fixed to the carbody or structural interior elements. This document applies to newly developed passenger seats and newly developed passenger seat components installed in passenger railway vehicles excluding trams and metros. This document does not specify — the structural performance for perch seats/standing support, — the fatigue performance for passenger seats, — the requirements for the installation of seats to the carbody structure, — the requirements for the aesthetics for passenger seats, — the ergonomics or comfort performance for passenger seats, — the requirements for interior passive safety and dynamic structural integrity for passenger seats, — the requirements for natural frequencies and resonance, — the requirements for shock and impact (vandalism loads).

 

This document applies to testing of rails installed in track for detecting internal discontinuities. This part applies to testing equipment fitted to dedicated test vehicles or manually-propelled devices. This document does not define the requirements for vehicle acceptance. This part of the series does not apply to ultrasonic testing of rails in a production plant. The 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 applies only to rail profiles meeting the requirements of EN 13674 1.

 

This document specifies minimum requirements and test methods for systems recognising involuntarily submersion of humans in managed public aquatic facilities. It specifies the function, operation and performance of systems recognising involuntarily submersion of humans in managed public aquatic facilities. It is applicable to managed aquatic facilities such as indoor pool, outdoor pools and natural pools.

 

This document specifies a framework for the generation process of tyre model parameter sets, including a classification of the data sources and methods used. This document focuses on the process of generating the tyre model parameter sets covering the definition of required input data for certain standard applications. This document enables a structured exchange between tyre model users and tyre model providers by defining a fitting report for the tyre model parameter set. The exchanged information shall ensure that the tyre model parameter sets are suitable for the intended range of applications, and enable the model providers to ensure that all relevant model features are parameterized for the intended operating conditions and based on suitable input data by increasing transparency and traceability.

 

This document provides general definitions for sample collection and preparation of a representative sample based on a sampling plan for the purpose of determining dimensions and impurities.

 

This document specifies a calculation method to determine the thermal transmittance of glass with flat and parallel surfaces. This document applies to uncoated glass (including glass with structured surfaces, e.g. patterned glass), coated glass and materials not transparent in the far infrared which is the case for soda lime glass products, borosilicate glass, glass ceramic, alkaline earth silicate glass and alumino silicate glass. It applies also to multiple glazing comprising such glasses and/or materials. It does not apply to multiple glazing which include in the gas space sheets or foils that are far infrared transparent. The procedure specified in this document determines the U value (thermal transmittance) in the central area of glazing. The edge effects due to the thermal bridge through the spacer of an insulating glass unit or through the window frame are not included. Furthermore, energy transfer due to solar radiation is not taken into account. The effects of Georgian and other bars are excluded from the scope of this document. NOTE EN ISO 10077 1:2017 provides a methodology for calculating the overall U value of windows, doors and shutters [1], taking account of the U value calculated for the glass components according to this document. Also excluded from the calculation methodology are any effects due to gases that absorb infrared radiation in the 5 to 50 µm range. The primary purpose of this document is product comparison, for which a vertical position of the glazing is specified. In addition, U values are calculated using the same procedure for other purposes, in particular for predicting: - heat loss through glass; - conduction heat gains in summer; - condensation on glass surfaces; - the effect of the absorbed solar radiation in determining the solar factor [2]. Reference can be made to [3], [4] and [5] or other European Standards dealing with heat loss calculations for the application of glazing U values determined by this standard. Reference can be made to [6] for detailed calculations of U values of glazing, including shading devices. Vacuum Insulating Glass (VIG) is excluded from the scope of this document. For determination of the U value of VIG, please refer to EN 674 or ISO 19916-1. A procedure for the determination of emissivity is given in EN 12898. The rules have been made as simple as possible consistent with accuracy.

 

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this document do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation.  As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This document may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

 

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). The integrated features refer to: leucocyte filter; pre-donation sampling device; top and bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.