Palvelualojen työnantajat PALTA

 

 

This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide (VH2O2) as the sterilizing agent. NOTE Requirements for validation and control of VH2O2 sterilization processes are provided in ISO 22441. This document does not cover biological indicators used for hydrogen peroxide (H2O2) biodecontamination systems such as those used for rooms, enclosures or environmental spaces.

 

This document contains the basic control strategy, minimum functionality requirements, basic driver interface elements, minimum requirements for diagnostics and reaction to failure, and performance test procedures for Partially Automated In-Lane Driving Systems (PADS). This document is applicable to passenger cars, commercial vehicles and buses. It is not applicable to automated driving systems of level 3 or higher (as defined in ISO/SAE PAS 22736:2021). Note 1 to entry Lane changing is addressed in ISO 21202:2020.

 

This document specifies the basic control strategy, minimum functionality requirements, basic driver interface elements, minimum requirements for diagnostics and reaction to failure, and performance test procedures for Adaptive Cruise Control (ACC) systems.

 

This document specifies characteristics concerning the design and performance requirements together with type testing and on-site testing procedures especially for ducted filtration fume cupboards (DFFCs) not described in the other parts of EN 14175. Filters in DFFCs can be specific filters or a combination of filters dependent on the characteristics of the contaminants to be removed. This part of EN 14175 is related to and refers to other parts of EN 14175 regarding definitions, technologies, testing methodologies, design factors and functional aspects and is read in conjunction with these. This standard covers the specific layout version of ducted fume cupboards with integral filtration. These devices called ducted filtration fume cupboards can be designed to partially reuse filtered air for internal dilution. Therefore, the term “hybrid” fume cupboards is sometimes used. Fume cupboards with associated filters are considered as standard fume cupboards according EN 14175 1 to EN 14175 3. NOTE Their filter requirements, description and testing are listed in Annex A for information. The requirements for fume cupboards and filters for radioactive work are described in detail in EN 14175 8. Recirculatory filtration fume cabinets which return the filtered exhaust air back into the surrounding room are not part of this document but described in prEN 17242. DFFCs are not foreseen for work with pathogens. Appropriate microbiological cabinets are described in the EN 12469 series.

 

This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent. NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for workplace safety.

 

Healthcare Organization Management—Guidelines for Hospital Internal Logistics Services using Autonomous Mobile Robots for the delivery of pharmaceuticals This document gives guidelines for Healthcare Organization Management, including healthcare suppliers and manufacturers of Autonomous Mobile Robots(AMRs), where they implement the hospital internal logistics using autonomous mobile robots. It includes the key components that should be considered to provide safe and reliable hospital internal logistics of pharmaceuticals. This document specifically addresses the use of Autonomous Mobile Robots (AMRs) for the transport and delivery of pharmaceuticals within the hospital environment. It covers the physical arrangement of AMR, including medication packaging, delivery chambers, emergency halt method and logistics environment of hospitals such as elevator in-and-out sequence and locations of the delivery.

 

This document specifies the requirements for efficient portable devices management in smart hospitals using the real-time location system (RTLS). This document aims to promote data interoperability between RTLS systems andhospital information system (such as HIS and EMR).hospital information system It is recommended to reference or adopt internationally recognized healthcare data exchange standards, such as the HL7 FHIR Real-Time Location Services Implementation Guide (HL7 RTLS IG). Out of scope: RTLS technical specifications (tags/beacons, scanner), refer to ISO/IEC 24730, 24770, and 24769 series; — Network configurations or specifications for installing RTLS devices; — Detailed RTLS testing and validation methods.

 

This document defines detailed use cases, requirements and message specifications for supporting indoor navigation functionality between a personal/vehicle (P/V) ITS station and a central ITS station. This document defines: a) Clusters of use cases based on processing flows for indoor navigation between a P/V ITS station and a central ITS station; b) Detailed use cases derived from the clusters of use cases for indoor navigation; c) Message specifications to support some of the detailed use cases. This document is only applicable to the core flow for the navigational functionality in indoor space. The following issues which are adjunctive but essential for commercial navigation services are beyond the scope of this document: — Authorized and authenticated access of users and services, including security; — Payment; — Preparation of indoor data which are necessary for indoor navigation; — Detailed data formats for indoor navigation data, including indoor maps and indoor positioning references (these form a part of ISO 17438-2, ISO 17438-3 and ISO 17438-5); — How to transfer and share data required for indoor navigation between a roadside ITS station and a central ITS station, i.e. low-level communication protocols; — Other issues dependent on implementation of an instance of indoor navigation, e.g. indoor-outdoor seamless navigation.

 

This document specifies tests for electromagnetic immunity of electronic components for passenger cars and commercial vehicles, regardless of the propulsion system (e.g. spark-ignition engine, diesel engine, electric motor) to magnetic fields. These sources are classified into internal magnetic field (sources internal to the vehicle, e.g. vehicle electro-mechanical motors, actuators) and external magnetic field (sources external to the vehicle, e.g. power transmission lines, generating stations). To perform this test, the device under test (DUT) is exposed to a magnetic disturbance field. This standard includes 2 alternative test methods: — the radiating loop and — the Helmholtz coil method. The electromagnetic disturbances considered in this document are limited to unmodulated sine wave (CW) magnetic fields.

 

This document provides terms and definitions in the field of esports.

 

This part of ISO 17438 specifies the indoor navigation system architecture including additional components that are added to the existing ITS system and use cases in providing indoor navigation to various types of users including drivers, passengers, and pedestrians using personal and vehicle ITS stations. For the purposes of this document, personal and vehicle ITS stations are limited to nomadic devices used for indoor navigation. Accordingly, indoor navigation functions and services provided by nomadic devices are within the scope of this document, and indoor navigation provided by devices installed in vehicles is outside the scope of this document. The personal and vehicle ITS station in the role of end user terminal running indoor navigation functionality. — Indoor map containing indoor geometry, network topology, and POI data reflecting characteristics of indoor space. — Indoor positioning reference data containing information of positioning infrastructure: WiFi AP, RFID Reader, Bluetooth AP, etc. — Data providers to provision the indoor map or indoor positioning reference data. — Indoor data registry server to provision the information of indoor data server. — Indoor positioning functionality in the personal and vehicle ITS station using indoor positioning reference data. — Indoor positioning functionality in the central ITS station using indoor positioning reference data. — Interface between the P/V ITS station and central ITS station to communicate indoor map data and indoor positioning reference data. This part of ISO 17438 includes “General Information”, which provides a general overview and structure of each part of ISO 17438. It also specifies “Use Cases” related to the indoor navigation for personal and vehicle ITS stations.

 

This document is applicable to endodontic ultrasonic inserts, operated in combination with either air or electrically powered stand-alone handpieces or handpieces connecting to dental units. This document specifies requirements and test methods for inserts, and requirements for marking, labeling and packaging.

 

This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

 

This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

 

This document specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

 

This document specifies minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.

 

ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants. NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary. It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system. Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016. While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources. Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016. Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539-1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts). NOTE Requirements for endovascular prostheses are specified in ISO 25539-1. The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices. Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016. NOTE Requirements for vascular stents are specified in ISO 25539-2. Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201

 

This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. Note Two of the requirements apply only to dental mercury (as supplied) and two to dental mercury sachets. All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam. This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount appropriate to make a small to medium-sized restoration in a single tooth. This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.

 

This document specifies product specification for vacuum insulating glass (VIG). It also specifies evaluation methods for performance and evaluation methods for thermal insulation durability. The products applied to this standard are: — VIG without further processing; — VIG further processed into a laminated glass; — VIG backed with an adhesive (safety) film. — Hybrid VIG (h-VIG), i.e. insulating glass unit (IGU) in which one pane is a VIG.