Palvelualojen työnantajat PALTA

 

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:

 

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.

 

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.

 

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.

 

 

ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels. The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644-9 and ISO 14644-10. The following matters of general guidance will be provided: - expected surface cleanliness levels; - suitability of cleaning methods; - compatibility of surfaces with the cleaning technique; - assessment of cleaning appropriateness. The following will be excluded from this document: - classification of cleaning methods; - product produced within a cleanroom; - specific surface-related cleaning methods; - detailed description of cleaning mechanisms, methods and procedures of various cleaning methods; - detailed material characteristics; - description of damage mechanisms by cleaning processes and time-dependent effects; - references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent; - other characteristics of particles such as electrostatic charge, ionic charges, etc.; - chemical reactions between molecular contaminants and surfaces; - microbiological aspects of surface cleanliness; - radioactive aspects of contamination; - health and safety considerations; - environmental aspects such as waste disposal, emissions, etc.; - selection and use of statistical methods.

 

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644-1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644-1). NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required. The following items are not covered by this ISO 14644-14:2016: - assessment of suitability with respect to biocontamination; - testing for suitability of decontamination agents and techniques; - cleanability of equipment and materials; - requirements on design of equipment and selection of materials; - physical properties of materials (e.g. electrostatic, thermal properties); - optimizing performance of equipment for specific process applications; - selection and use of statistical methods for testing; - protocols and requirements for local safety regulations.