Palvelualojen työnantajat PALTA

 

This document defines terms, establishes manufacturing, safety and functional requirements and corresponding tests, and specifies data for marking, labelling and instructions for use, for pressure cookers. This document is applicable to portable pressure cookers for domestic use, with gross volume up to 25 l, with control pressure over 4 kPa and less than 150 kPa, with either integrated or independent heating (e.g. gas burner, electrical plate, induction hobs, ceramic hobs). NOTE All pressures mentioned in this text are related to atmospheric pressure.

 

This document describes the basic requirements for the verification of ultimate and serviceability limit states and the resistance to fatigue either of the noise barrier or its components by means of analytical methods and/or tests. Analytical methods can be used for the determination of the characteristic values and design values. Where sufficient information is not available, the analytical procedure can be combined with results from tests. This document provides the following types of test procedures: - test on small samples for defining detail categories, which might not be covered by Eurocodes (verification procedure A); - test on a global element for defining the limit state against fatigue (verification procedure B); - full scale tests under a given representative loading (verification procedure C) to determine fatigue resistance of the noise barrier components for defined loading conditions; verification procedure C is given as alternative to verification procedures A and B.

 

 

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing human materials which are non-viable or have been rendered non-viable. The document specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for determining the acceptability of residual risks, taking into account the risk profile and expected benefit as compared to available alternatives, in line with ISO 14971. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human materials such as: This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not address requirements for consent to donation of human materials.

 

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

 

This document specifies the concept of operation, minimum functionality, system requirements, system interfaces, and test procedures for Pedestrian Detection and Collision Mitigation Systems (PDCMS). It specifies the behaviours that are required for PDCMS, and the system test criteria necessary to verify that a given implementation meets the requirements of this document. Implementation choices are left to system designers wherever possible. PDCMS reduce the severity of pedestrian collisions that cannot be avoided, and may reduce the likelihood of fatality and severity of injury. PDCMS require information about range to pedestrians, motion of pedestrians, motion of the subject vehicle (SV), driver commands and driver actions. PDCMS detect pedestrians ahead of time, determine if detected pedestrians represent a hazardous condition, and warn the driver if a hazard exists. PDCMS estimate if the driver has an adequate opportunity to respond to the hazard. If there is inadequate time available for the driver to respond, and if appropriate criteria are met, PDCMS determine that a collision is imminent. Based upon this assessment, PDCMS will activate CWs and vehicle brakes to mitigate collision severity. This document, while not a collision avoidance standard, does not preclude a manufacturer from implementing collision avoidance with PDCMS. Systems that include other countermeasures such as evasive steering are not within the scope of this document. Responsibility for the safe operation of the vehicle remains with the driver. This document applies to light duty passenger vehicles (see 3.6). It does not apply to other vehicle categories such as heavy vehicles or motorcycles. PDCMS are not intended for off-road use.

 

This document gives requirements and the corresponding test/assessment methods applicable to leak detectors based on the drop of the liquid level in the leak detection liquid reservoir. Leak detectors are intended to be used with double skin, underground or above ground, non-pressurized tanks designed for water polluting liquids. The liquid leak detectors are usually composed of: - sensing device (liquid sensor); - evaluation device; - alarm device.

 

This document specifies requirements and the corresponding test/assessment methods applicable to leak detection linings and leak detection jackets. Leak detection linings and leak detection jackets are intended to be used, in conjunction with leak detection kits, to create an interstitial space or leakage containment in single skin underground or above ground, non-pressurized tanks designed for water polluting liquids. For leak detection kits, see EN 13160 2, EN 13160 3 and EN 13160 4.

 

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

 

This document gives requirements and the corresponding test/assessment methods applicable to sensor-based leak detection systems (leak detectors) for liquids and/or for gases. The leak detectors are intended to be used in interstitial spaces, leakage containments or monitoring wells. The leak detectors are usually composed of: - sensing device(s); - evaluation device; - alarm device.

 

This document gives requirements and the corresponding test/assessment methods applicable to leak detector based on the measurement of pressure change. Leak detectors are intended to be used with double skin, underground or above ground, pressurized or non-pressurized, tanks or pipe designed for water polluting liquids/fluids. The leak detectors are usually composed of: - measuring device; - evaluation device; - alarm device; - pressure generator; - pressure relief device; - liquid stop device; - condensate trap.

 

This document specifies the classification for respiratory infection prevention devices (RIPDs). RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment, and also reduce exposure to the user from inhalation of infective agents. RIPDs are intended for use by everybody regardless of facial morphology or ability.

 

This document provides additional terms and definitions to those written in the Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR) or the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID), appearing as Appendix C to the Convention concerning International Carriage by Rail (COTIF). This document forms part of series of documents prepared by CEN/TC 296 regarding the transport of dangerous goods. The series supports the proper application of the ADR and RID. This document is applicable to tanks used for the transport of dangerous goods. This document does not apply to carriage in bulk of dangerous goods. For convenience, Annex A (informative) repeats some horizontal definitions taken from ADR and RID 2025 chapter 1.2, and Annex B (informative) repeats some definitions from ADR and RID 2025 chapter 6.7, specific to portable tanks. NOTE The ADR and RID are updated on a regular basis, therefore Annexes A and B might become out of date. For outdated definitions, the RID/ADR take precedence. Annexes C, D and E (informative) provide alphabetical trilingual indexes of terms in English, French and German where the key is English, French and German respectively. Annex F (normative) is a schematic diagram of tank openings and closures according to the tank code.

 

This document specifies the requirements for the design, dimensions, performance, and testing of a brake block that acts on the wheel tread as part of a tread brake system. NOTE In the scope of Commission Regulation (EU) N° 321/2013 (TSI WAG) the brake block is a friction element for wheel tread brakes. This document does not cover cast iron brake block requirements. This document is applicable to brake blocks of various friction level designed to be fitted to tread braked rail vehicles. This document contains the requirements for interfacing the brake block with the rail vehicle, the testing procedures in order to confirm that it satisfies the basic safety and technical interchangeability requirements, the material control procedures to ensure product quality, reliability and conformity and considers health and environmental needs.

 

This document provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). Not in the scope of this standard:

 

This document specifies the functional requirements for rail vehicle windscreens, including type testing, routine testing, and inspection methods for main line railway systems and urban guided transport. This document applies to windscreens made of laminated glass, which is the most commonly used material but also to other materials, subject to the performance requirements being satisfied. For on-track machines (OTMs) when in transport mode (self-propelled or hauled) the requirements of this standard are applicable. OTMs in working configuration are outside the scope of this document. Determination of the size, shape, orientation, and position of windscreens is outside the scope of this document. This document does not specify requirements for the interfaces between the windscreen and the vehicle. Accordingly this document does not address issues relating to installation, structural integrity, and crashworthiness.

 

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials. In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

 

In respect of pan European eCall (operating requirements defined in EN 16072), this document defines the high level application protocols, procedures and processes required to provide the eCall service via a packet switched wireless communications network using IMS (IP Multimedia Subsystem) and wireless access (such as LTE, NR and their successors). This document assumes support of eCall using IMS over packet switched networks by an IVS and a PSAP and further assumes that all PLMNs available to an IVS at the time an eCall or test eCall is initiated are packet switched networks. Support of eCall where eCall using IMS over packet switched networks is not supported by an IVS or PSAP is out of scope of this document. At some moment in time packet switched networks will be the only Public Land Mobile Networks (PLMN) available. However as long as GSM/UMTS PLMNs are available (Teleservice 12/TS12) ETSI TS 122 003 will remain operational. Both the use of such PLMNs and the logic behind choosing the appropriate network in a hybrid situation (where both packet-switched and circuit-switched networks are available) are out of scope of this document. NOTE 1 The objective of implementing the pan-European in-vehicle emergency call system (eCall) is to automate the notification of a traffic accident, wherever in Europe, with the same technical standards and the same quality of services objectives by using a PLMN (such as ETSI prime medium) which supports the European harmonized 112/E112 emergency number (TS12 ETSI TS 122 003 or IMS packet switched network) and to provide a means of manually triggering the notification of an emergency incident. NOTE 2 HLAP requirements for third party services supporting eCall can be found in EN 16102. This document makes reference to those provisions but does not duplicate them.

 

This document defines the key actors in the eCall chain of service provision using IMS over packet switched networks (such as LTE/4G) as: 1) In-vehicle system (3.20) (IVS)/vehicle, 2) Mobile network Operator (MNO), 3) Public safety answering point (3.27) (PSAP), and to provide conformance tests for actor groups 1) - 3). NOTE 1 Conformance tests are not appropriate nor required for vehicle occupants (3.36), although they are the recipient of the service. NOTE 2 Third party eCall systems (TPS eCall) are not within the scope of this deliverable. This is because the core TPS-eCall (3.32) standard (EN 16102) does not specify the communications link between the vehicle and the TPS service provider (3.29). NOTE 3 These conformance tests are based an the appropriate conformance tests from EN 16454 which was published before Internet Protocol multimedia Systems (IMS) packet switched networks were available. This deliverable therefore replicates the appropriate tests from EN 16454 (and acknowledge their source); adapt and revise Conformance Test Protocols (CTP) from EN 16454 to an IMS paradigm; or provide new additional tests that are required for the IMS paradigm. Some 14 112-eCall (Pan European eCall) tests provided in EN 16454 are specific to GSM/UMTS circuit switched communications and not appropriate for the IMS paradigm and are therefore excluded from this deliverable. This document therefore provides a suite of ALL conformance tests for IVS equipment, MNO's, and PSAPS, required to ensure and demonstrate compliance to CEN/TS 17184. NOTE 4 Because in the event of non-viability or non-existence of an IMS supporting network at any particular time/location, IMS-eCall systems revert to CS networked eCall systems eCall via GSM/UMTS, IVS and PSAPs need to support, and prove compliance to both IMS and CS switched networks. The Scope covers conformance testing (and approval) of new engineering developments, products and systems, and does not imply testing associated with individual installations in vehicles or locations.