Yhteinen Toimialaliitto

Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 194 (Biological and clinical evaluation of medical devices)
Alkuperä: ISO
Määräpäivä: 2024-07-23
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This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of materials intended for use in medical devices. In order to evaluate local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, this document is applicable when required. This document applies to medical device/materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable/degradable or non- absorbable, or can be tissue-engineered medical products (TEMPs). These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biocompatibility effects.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 55 (Dentistry)
Alkuperä: CEN
Määräpäivä: 2024-07-25
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This document specifies polymers commonly used in manufacturing dental instruments. It is applicaple to polymers materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, connected to a power-driven system or not. This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of polymers. It contains a current selection of polymers suitable for use in the manufacture of dental instruments.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 32 (Electrical and electronic components and general system aspects)
Alkuperä: ISO
Määräpäivä: 2024-07-25
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This document defines terms related to the ignition systems of spark-ignited internal combustion, mainly but not solely intended for use in road vehicles.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 55 (Dentistry)
Alkuperä: CEN
Määräpäivä: 2024-07-25
LaajennaSupista
 
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 393 (Equipment for storage tanks and for filling stations)
Alkuperä: CEN
Määräpäivä: 2024-07-25
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This document contains requirements, test and assessment methods, marking, labelling and packaging applicable to overfill prevention devices with closure device. The devices are usually composed by: - sensor; - evaluation device; - closure device. Overfill prevention devices intended to be used in/with underground and/or above ground, non-pressurized, static tanks designed for liquid fuels. NOTE Liquid fuel means liquids for internal combustion engines, heating/cooling boilers and generators.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 210 (Quality management and corresponding general aspects for products with a health purpose including medical devices)
Alkuperä: ISO
Määräpäivä: 2024-07-25
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Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 206 (Biological and clinical evaluation of medical devices)
Alkuperä: CEN
Määräpäivä: 2024-07-25
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Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 136 (Sports, playground and other recreational facilities and equipment)
Alkuperä: CEN
Määräpäivä: 2024-07-25
LaajennaSupista
 
This document specifies safety requirements for starting platforms with a height = 750 mm above water level. These requirements are additional to those given in EN 13451-1 and these documents are intended to be read together. The requirements of this specific standard take priority over those in EN 13451-1. This document is applicable to starting platforms for use in classified swimming pools as specified in EN 15288-1 and EN 15288-2.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 216 (Chemical disinfectants and antiseptics)
Alkuperä: CEN
Määräpäivä: 2024-07-25
LaajennaSupista
 
This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and could occur in the workplace and in the home. It could also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-07-29
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This document gives an overview of the structure and the partitioning of this document series (all parts). In addition, it outlines the use case where the document series (all parts) is used. The terminology defined in this document is common for all LIN communication systems and is used throughout the document series. This document has been established to define the use cases for LIN.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-07-30
LaajennaSupista
 
This document specifies a transport protocol and network layer services tailored to meet the requirements of LIN-based vehicle network systems on local interconnect networks. The protocol specifies an unconfirmed communication. The LIN protocol supports the standardized service primitive interface as specified in ISO 14229-2. This document provides the transport protocol and network layer services to support different application layer implementations like The transport layer defines transportation of data that is contained in one or more frames. The transport layer messages are transported by diagnostic frames. A standardized API is specified for the transport layer. Use of the transport layer is targeting systems where diagnostics are performed on the backbone bus (e.g. CAN) and where the system builder wants to use the same diagnostic capabilities on the LIN sub-bus clusters. The messages are in fact identical to the ISO 15765-2 and the PDUs carrying the messages are very similar. The goals of the transport layer are A typical system configuration is shown in Figure 1.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-07-31
LaajennaSupista
 
This document specifies the LIN protocol including the signal management, frame transfer, schedule table handling, task behaviour and status management and LIN commander and responder node. It contains also OSI layer 5 properties according to ISO 14229-7 UDSonLIN-based node configuration and identification services (SID: B016 to B816) belonging to the core protocol specification. A node (normally a commander node) that is connected to more than one LIN network is handled by higher layers (i.e. the application) not within the scope of this document.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-07-31
LaajennaSupista
 
This document specifies the 12 V and 24 V electrical physical layers (EPL) of the LIN communications system. The electrical physical layer for LIN is designed for low-cost networks with bit rates up to 20 kbit/s to connect automotive electronic control units (ECUs). The medium that is used is a single wire for each receiver and transmitter with reference to ground. This document includes the definition of electrical characteristics of the transmission itself and also the documentation of basic functionality for bus driver devices. All parameters in this document are defined for the ambient temperature range from -40 °C to 125 °C.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-08-05
LaajennaSupista
 
This document specifies the LIN protocol conformance test. This test verifies the conformance of LIN communication controllers with respect to ISO 17987-2 and ISO 17987-3. This document provides all necessary technical information to ensure that test results are identical even on different test systems, provided that the particular test suite and the test system are compliant to the content of this document.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 22/SC 31 (Data communication)
Alkuperä: ISO
Määräpäivä: 2024-08-05
LaajennaSupista
 
This document specifies the conformance test for the electrical physical layer (EPL) of the LIN communications system. It is part of this document to define a test that considers ISO 9646 and ISO 17987–4. The purpose of this document is to provide a standardised way to verify whether a LIN bus driver is compliant to ISO 17987–4. The primary motivation is to ensure a level of interoperability of LIN bus drivers from different sources in a system environment. This document provides all the necessary technical information to ensure that test results are consistent even on different test systems, provided that the particular test suite and the test system are compliant to the content of this document.
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 216 (Chemical disinfectants and antiseptics)
Alkuperä: CEN
Määräpäivä: 2024-08-08
LaajennaSupista
 
TThis document specifies a test method and the minimum requirements for virucidal 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, i.e, products that are not diluted when applied, - with water. Ready-to-use-products can only be tested at a concentration up to 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection. This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 1 test. NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 121/SC 3 (Respiratory devices and related equipment used for patient care)
Alkuperä: ISO
Määräpäivä: 2024-08-09
LaajennaSupista
 
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: CEN/TC 278 (Intelligent transport systems)
Alkuperä: CEN
Määräpäivä: 2024-08-15
LaajennaSupista
 
This document specifies and defines components required to support the exchange and shared use of data and information in the field of traffic and travel. The components include the framework and context for the modelling approach, data content, data structure and relationships. This document is applicable to: • Traffic and travel information which is of relevance to road networks (non-urban and urban), • Public transport information that is of direct relevance to the use of a road network (e.g. road link via train or ferry service). • Traffic and travel information in the case of Cooperative intelligent transport systems (C-ITS). This document establishes specifications for data content to be exchanged between any two instances of the following actors: • Traffic Information Centres (TICs), • Traffic Control Centres (TCCs), • Service Providers (SPs), Use of this document may be applicable for use by other actors. This part of EN 16157 specifies the DATEX II framework of all parts of this European Standard, the context of use and the modelling approach taken and used throughout these European Standards. This approach is described using formal methods and provides the mandatory reference framework for all other parts
Toimialayhteisö: Yhteinen Toimialaliitto
Komitea: ISO/TC 209 (Cleanrooms and associated controlled environments)
Alkuperä: ISO
Määräpäivä: 2024-08-19
LaajennaSupista
 
This part of ISO 14644 specifies requirements for the establishment of an Operations Control Programme to ensure efficient cleanroom operation within specified cleanliness levels. The Operations Control Programme includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring. Normative operational requirements are presented that relate to: Additional informative annexes are provided for: Biocontamination control is not specifically addressed. For details, please refer to references [2], [3], and [4]. The following topics are omitted from this part of the standard: