Palvelualojen työnantajat PALTA

 

 

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge). It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

 

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

 

 

1.1 General Scope of the Standard The main objective of the present standard is to present the Reference Data Model for Public Transport, based on: - the Reference Data Model, EN12896, known as Transmodel V5.1, - CEN EN 28701, known as IFOPT, incorporating the requirements of - EN 15531-1 to -3 and TS 15531-4 and -5: Service interface for real-time information relating to public transport operations (SIRI), - TS 16614-1 and 2: Network and Timetable Exchange (NeTEx), in particular, the specific needs for long distance train operation. A particular attention is drawn to the data model structure and methodology: - the data model is described in a modular form in order to facilitate the understanding and the use of the model, - the data model is entirely described in UML. In particular, a Reference Data Model kernel is described, referring to the data domain: - Network Description: routes, lines, journey patterns, timing patterns, service patterns, scheduled stop points and stop places. This part corresponds to the Transmodel V5.1 Network Description extended by the IFOPT relevant parts. Furthermore, the following functional domains are considered: - Timing Information and Vehicle Scheduling (runtimes, vehicle journeys, day type-related vehicle schedules) - Passenger Information (planned and real-time) - Fare Management (fare structure, sales, validation, control) - Operations Monitoring and Control: operating day-related data, vehicle follow-up , control actions - Management Information and Statistics (including data dedicated to service performance indicators). - Driver Management: - Driver Scheduling (day-type related driver schedules), - Rostering (ordering of driver duties into sequences according to some chosen methods), - Driving Personnel Disposition (assignment of logical drivers to physical drivers and recording of driver performance). The data modules dedicated to cover most functions of the above domains will be specified. Several concepts are shared by the different functional domains. This data domain is called “Common Concepts”. 1.2 Functional Domain Description The different functional domains taken into account in the present standard and of which the data have been represented as the reference data model are described in “Public Transport Reference Data Model - Part 1: Common Concepts”. They are: - Public Transport Network and Stop Description - Timing Information and Vehicle scheduling - Passenger information - Fare Management - Operations monitoring and control - Management information - Personnel Management: Driver Scheduling, Rostering, Personnel Disposition. The aspects of multi-modal operation and multiple operators’ environment are also taken into account. 1.3 Particular Scope of this Document The present European Standard entitled “Reference Data Model for Public Transport – Part 3: Timing Information and Vehicle Scheduling”. incorporates - Journey and Journey Times Model: describes the time-related information at the level of vehicle journeys, i.e. planned timing for the vehicles at day-type level. - Dated Journey Model: describes the link of the timing information for a single operating day and the day type related timing, - Passing Times Model: describes all the different types of passing times for the day type related information, - Vehicle Service Model: describes the information related the work of vehicles as planned for days types. It constitutes the main part of the Vehicle Scheduling Data Domain. - Vehicle Journey Assignment Model: describes operational assignments (advertised vehicle labels, stopping positions) related to particular vehicle journeys. This document itself is composed of the following parts: - Main document (normative) representing the data model, (...)

 

1.1 General Scope of the Standard The main objective of the present standard is to present the Reference Data Model for Public Transport, based on: - the Reference Data Model, EN 12896, known as Transmodel V5.1; - EN 28701:2012, Intelligent transport systems - Public transport - Identification of Fixed Objects in Public Transport (IFOPT), although note that this particular standard has been withdrawn as it is now included within Parts 1 and 2 of this standard (EN 12896-1:2016 and EN 12896-2:2016) following their successful publication. incorporating the requirements of: - EN 15531-1 to -3 and CEN/TS 15531-4 and -5: Public transport - Service interface for real-time information relating to public transport operations (SIRI); - CEN/TS 16614-1 and -2: Public transport - Network and Timetable Exchange (NeTEx), in particular the specific needs for long distance train operation. Particular attention is drawn to the data model structure and methodology: - the data model is described in a modular form in order to facilitate the understanding and the use of the model; - the data model is entirely described in UML. The following functional domains are considered: - Network Description: routes, lines, journey patterns, timing patterns, service patterns, scheduled stop points and stop places; - Timing Information and Vehicle Scheduling (runtimes, vehicle journeys, day type-related vehicle schedules); - Passenger Information (planned and real-time); - Fare Management (fare structure, sales, validation, control); - Operations Monitoring and Control: operating day-related data, vehicle follow-up, control actions; - Driver Management: - Driver Scheduling (day-type related driver schedules), - Rostering (ordering of driver duties into sequences according to some chosen methods), - Driving Personnel Disposition (assignment of logical drivers to physical drivers and recording of driver performance); - Management Information and Statistics (including data dedicated to service performance indicators). The data modules dedicated to cover most functions of the above domains will be specified. Several concepts are shared by the different functional domains. This data domain is called "Common Concepts". 1.2 Functional Domain Description The different functional domains (enumerated above) taken into account in the present standard, and of which the data have been represented as the reference model, are described in EN 12896-1:2016, Public transport - Reference data model - Part 1: Common concepts. 1.3 Particular Scope of this Document The present document entitled Public transport - Reference data model - Part 5: Fare Management addresses Fare Information for Public Transport and incorporates the following data packages: - Fare Structure; - Access Right Assignment; - Fare Pricing; - Sales Description; - Sales Transaction; - Fare Roles; - Validation and Control; - Explicit Frames for Fares. This document itself is composed of the following parts: - Main document (normative) representing the data model for the concepts shared by the different fare domains covered by Transmodel, - Annex A (normative), containing the data dictionary, i.e. the list of all the concepts and attribute tables present in the main document together with the definitions, - Annex B (normative), providing a complement to the "Common Concepts" domain, particularly useful for parts 4 to 8 of the Public Transport Reference Data Model, Annex C (informative), indicating the data model evolutions from previous versions of Transmodel (EN 12896:2006).

 

This document incorporates the following main data packages: - Dated Production Components; - Call; - Dated Call; - Production Plan; - Detecting & Monitoring; - Situation; - Messaging; - Control Action; - Operational Event & Incident; - Facility Monitoring & Availability; - Occupancy. It is composed of the following parts: - main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative); - Annex A containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with their definitions (normative); - Annex B presenting the model evolution (informative); - Annex C detailing the mapping to DATEX-II and SIRI (informative). - Annex D, providing details of the significant technical changes between this document and EN 12896 4:2019 (informative).

 

1.1 General scope of the Standard The main objective of this European Standard is to present the Public Transport Reference Data Model based on: - the Public Transport Reference Data Model published 2006 as EN12896 and known as Transmodel V5.1, - the model for the Identification of Fixed Objects for Public transport, published 2009 as EN 28701and known as IFOPT, incorporating the requirements of - EN15531-1 to 3 and TS15531-4 and 5: Service interface for real-time information relating to public transport operations (SIRI), - TS16614-1 and 2: Network and Timetable Exchange (NeTEx), in particular the specific needs for long distance train operation. Particular attention is drawn to the data model structure and methodology: - the data model is described in a modular form in order to facilitate understanding and use of the model, - the data model is entirely described in UML. In particular, a Reference Data Model kernel is described, referring to the data domain: - Network Description: routes, lines, journey patterns, timing patterns, service patterns, scheduled stop points and stop places. This part corresponds to the network description as in Transmodel V5.1 extended by the relevant parts of IFOPT. Furthermore, the following functional domains are considered: - Timing Information and Vehicle Scheduling (runtimes, vehicle journeys, day type-related vehicle schedules) - Passenger Information (planned and real-time) - Operations Monitoring and Control: operating day-related data, vehicle follow-up , control actions - Fare Management (fare structure and access rights definition, sales, validation, control) - Management Information and Statistics (including data dedicated to service performance indicators). - Driver Management: - Driver Scheduling (day-type related driver schedules), - Rostering (ordering of driver duties into sequences according to some chosen methods), - Driving Personnel Disposition (assignment of logical drivers to physical drivers and recording of driver performance). The data modules dedicated to cover most functions of the above domains will be specified. Several concepts are shared by the different functional domains. This data domain is called “Common Concepts”. 1.2 Functional domain description 1.2.1 Public transport network and stop description The reference data model includes entity definitions for different types of points and links as the building elements of the topological network. Stop points, timing points and route points, for instance, reflect the different roles one point may have in the network definition: whether it is used for the definition of (topological or geographical) routes, as a point served by vehicles when operating on a line, or as a location against which timing information like departure, passing, or wait times are stored in order to construct the timetables. The line network is the fundamental infrastructure for the service offer, to be provided in the form of vehicle journeys which passengers may use for their trips. The main entities describing the line network in the reference data model are the line, the route and the journey pattern, which refer to the concepts of an identified service offer to the public, the possible variants of itineraries vehicles would follow when serving the line, and the (possibly different) successions of stop points served by the vehicles when operating on the route. The functional views of the network are described as layers. A projection is a mechanism enabling the description of the correspondence between the different layers. This mapping between the layers is particularly useful when spatial data from different environments (sources, functional domains) have to be combined. An example of such a situation is the mapping of the public transport network on the road network. (...)

 

This document incorporates the following main data packages: - Network Description; - Fixed Object; - Tactical Planning Components; - Explicit Frame. It is composed of the following parts: - main document representing the data model for the concepts shared by the different domains covered by Transmodel (normative); - Annex A containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with their definitions (normative); - Annex B presenting the model evolution (informative). - Annex C, providing details of the significant technical changes between this document and EN 12896-2:2016 (informative).

 

The document incorporates the following main data packages: - Trip Description; - Passenger Information Queries. It is composed of the following parts: - main document representing the data model for the concepts shared by the different fare domains covered by Transmodel (normative); - Annex A, containing the data dictionary and attribute tables, i.e. the list of all the concepts presented in the main document together with the definitions (normative); - Annex B presenting the model evolution (informative). - Annex C, providing details of the significant technical changes between this document and EN 12896 6:2019 (informative).

 

1.1 General Scope of the Standard The main objective of the present standard is to present the Reference Data Model for Public Transport, based on: - the Reference Data Model, EN 12896, known as Transmodel V5.1; - EN 28701:2012, Intelligent transport systems - Public transport - Identification of Fixed Objects in Public Transport (IFOPT), although note that this particular standard has been withdrawn as it is now included within Parts 1 and 2 of this European Standard (EN 12896-1:2016 and EN 12896-2:2016) following their successful publication; incorporating the requirements of: - EN 15531-1 to -3 and CEN/TS 15531-4 and -5: Public transport - Service interface for real-time information relating to public transport operations (SIRI); - CEN/TS 16614-1 and -2: Public transport - Network and Timetable Exchange (NeTEx), in particular the specific needs for long distance train operation. Particular attention is drawn to the data model structure and methodology: - the data model is described in a modular form in order to facilitate the understanding and the use of the model; - the data model is entirely described in UML. The following functional domains are considered: - Network Description: routes, lines, journey patterns, timing patterns, service patterns, scheduled stop points and stop places; - Timing Information and Vehicle Scheduling (runtimes, vehicle journeys, day type-related vehicle schedules); - Passenger Information (planned and real-time); - Fare Management (fare structure, sales, validation, control); - Operations Monitoring and Control: operating day-related data, vehicle follow-up, control actions; - Driver Management: - Driver Scheduling (day-type related driver schedules), - Rostering (ordering of driver duties into sequences according to some chosen methods), - Driving Personnel Disposition (assignment of logical drivers to physical drivers and recording of driver performance); - Management Information and Statistics (including data dedicated to service performance indicators). The data modules dedicated to cover most functions of the above domains will be specified. Several concepts are shared by the different functional domains. This data domain is called "Common Concepts". 1.2 Functional Domain Description The different functional domains (enumerated above) taken into account in the present document, and of which the data have been represented as the reference model, are described in EN 12896-1, Public transport - Reference data model - Part 1: Common concepts. 1.3 Particular Scope of this Document The present document entitled Public transport - Reference data model - Part 7: Driver management incorporates the following data packages: - Driver Scheduling; Rostering; - Personnel Disposition; - Driver Control Actions. This document itself is composed of the following parts: - Main document (normative) presenting the data model for the concepts shared by the different domains covered by Transmodel, - Annex A (normative), containing the data dictionary, i.e. the list of all the concepts and attribute tables present in the main document together with the definitions, - Annex B (normative), providing a complement to EN 12896-1:2016, particularly useful for Parts 4 to 8 of the Public Transport Reference Data Model; and - Annex C (informative), indicating the data model evolutions.

 

In order to reduce the impact of predictable natural hazards on railway operation, this document specifies a general concept and basic requirements for the planning of railway operation in the events of predictable natural hazards, focusing on heavy rainfall and strong wind. The given concepts and basic requirements do not apply to regions where the consequences of the addressed predictable hazards for railway operation are low or non-existent. The definition of such regions is out of the scope of this document. This document includes measures directly related to railway operation to reduce the impact in the events of predictable natural hazards. Furthermore, this document does not include specific measures which ensure passenger safety or which provide protection against railway-operational damage caused by the predictable natural hazards. Therefore, residual risk can remain.

 

This document specifies basic control strategies, minimum functional requirements, basic driver interface elements, and test procedures for verifying the system requirements for collision evasive lateral manoeuvre systems (CELM). A CELM is a safety system aimed at supporting the driver’s vehicle operation by avoiding collisions with objects in the forward path of the vehicle. When a collision is predicted, the CELM controls lateral movement of the vehicle by generating yaw moment. The lateral control manoeuvres can be performed automatically by CELM or can be initiated by the driver and supported by CELM. Specific methods for object detection and other environmental perception technologies are not described in this document. This document applies to light vehicles[1] and heavy trucks[1]. Vehicles equipped with trailers are not within the scope of this document.

 

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

 

ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

 

This document contains performance requirements and recommendations for electrical lighting systems in the interiors of conventional main line passenger railway vehicles, under all operating and emergency conditions. This document includes requirements for lighting installed for effect purposes (also referred to as decorative lighting). This document also defines the requirements for testing and conformity assessment. This document includes options for verification via modelling (also referred to as simulation). This document applies only to new units. This document does not apply retrospectively to existing railway vehicles for reasons of refurbishment or renewal unless stated otherwise in the Technical Specification. This document does not address lighting installed in instruments or control devices (for example backlit buttons). This document does not address requirements for the lighting of boarding aids, for example, moveable steps, bridging plates, or lifts. This document does not address indicator lights (for example access door indicators, which are addressed in other Standards). This document does not address requirements for display screens.

 

This document describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices and provides principles on designing and performing toxicokinetic evaluation relevant to medical devices.

 

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

 

This document specifies, principles and a process for the clinical evaluation of medical devices. This document specifies how to plan and perform clinical evaluation, including the collection, appraisal and analysis of data to assess the safety and, clinical performance or effectiveness, including clinical benefit(s) of medical devices, and to evaluate the acceptability of clinical risks when weighed against the clinical benefits achieved when the device under evaluation (DUE) is used as intended by the manufacturer. This includes the determination whether there is evidence for the assessment. This document also: — defines the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer, — assists manufacturers, regulatory authorities and other stakeholders involved in the process or assessment of the clinical evaluation of medical devices and, — provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions. This document does not apply to in vitro diagnostic medical devices. NOTE 1 National regulations can have additional or different requirements. NOTE 2 Some of the principles of this document can apply to actors other than manufacturers involved in clinical evidence generation.