Palvelualojen työnantajat PALTA

 

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.

 

This International Standard specifies requirements for determining commutability of a CRM (3.4)for which commutability (3.7) with clinical samples (3.6) is required, and the content of the supporting documentation. This standard is applicable to a commutable (3.7) CRM (3.4) intended for use as a secondary calibrator (3.32) or international conventional calibrator (3.13) in the m.3 position of calibration hierarchies described in ISO 17511 and that comply with the requirements of ISO 15194. This Standard is also applicable to a CRM (3.4) used as a trueness control (3.33) for an end-user measurement procedure (MP) (3.19). This standard applies primarily to commutable secondary calibrator (3.32) CRMs (3.4) with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in the scope of ISO 17511. For qualitative or visually interpreted measurement procedures, this document may serve as a conceptual framework, but additional criteria may apply. When a commutable secondary calibrator (3.32) CRM (3.4) includes multiple measurands, this Standard is applied to each of the measurands present in the CRM (3.4). This standard does not apply to a primary reference material (3.25) that consists of a defined high-purity analyte (3.1).

 

This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies product information to be provided. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see 7.3). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.

 

This document defines an application interface definition by selecting suitable options from the base standard EN ISO 12855:2021. Furthermore, it defines transfer mechanisms and supporting functions to ensure the interoperability between Toll Chargers and Toll Service Providers. This document covers: — exchange of information between the central equipment associated with the two roles service provision and toll charging, e.g.: o charging related data (exception lists, toll declarations, billing details, payment claims); o administrative data (trust objects, EFC context data, contact details for enforcement, etc.); o confirmation data. — transfer mechanisms and supporting functions; — semantics of data elements; — restrictions on parameters and their values — implementation conformance statement proforma, in an Annex, as a basis for assessment of conformity to this document; — an Interoperability statement proforma, in an Annex, as a basis for assessment of transactional interoperability of two technical implementations; — a web service definition, in an Annex, for the use of web services as communication technology. The implementation of the underlying back office systems and their business processes is not covered.

 

Transmodel is composed of 10 parts (see above). This work item consists in the revision and update of the documentation of the Public transport reference data model – Part 8 (Transmodel – Part 8). The update consists basically of the following types of actions: a. Simplication of Part 8 based on the revision of Part 1: several functional extensions of Transmodel took place since the last publication of EN12896 (in 2016 and 2019). The functional extensions elaborated until 2019 generated additional common concepts which have already been published in the relevant documents. These additional common concepts are now integrated into Transmodel - Part 1 and thus removed from Part 8. b. Updates/extensions of Part 8 as a consequence of • Work presented in TR17370:2019. This TR provides a list of KPIs calculated using operational raw data. The action consists here to provide data model extracts, representing the raw data needed for several KPIs (listed in TR17370:2019), The extracted sub-models are based upon the (already existing) "Loggable object model" and will complete the 2 examples published in the current version of Part 8. c. Ensuring coherence of the Transmodel eco-system. Several updates of Transmodel- Part 8 result from the discussions lead with the OpRa group and intend to ensure coherence with the OpRa Technical Specification.

 

This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

 

This document provides supplemental specifications to a physical layer capable of transmitting 1 Gbit/s over plastic optical fibre compliant with ISO/IEC/IEEE 8802-3:2017/Amd 9:2018, with specific application to communications inside road vehicles. Additionally, there is a test plan specified for conformance testing. The test plan includes test cases to ensure compliance of an IUT with the functionality specified in this document. ISO/IEC/IEEE 8802-3:2017/Amd 9:2018 is considered indispensable for the application of this document. The supplemental specifications include wake-up and synchronised link sleep functionality. The specification includes the sublayers, service interfaces, and state diagrams that support the functionality. The supplemental specifications are collected in protocol implementation conformance statement (PICS). The requirements specified in ISO/IEC/IEEE 8802-3:2017/Amd 9:2018 and in this document constitute the complete PICS that specifies the GEPOF physical entity functionality. The optical component requirements and test methods for optical 1-Gbit/s transmission of in-vehicle Ethernet are not within the scope of this document.

 

This document specifies the requirement and methods for the clinical performance verification of ME equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare environment and emergency medical services environment). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 [2] undergoing clinical performance verification according to this document. This document specifies additional disclosure requirements for the accompanying information of sphygmomanometers that conform with this document. This document is not applicable to the clinical performance verification of a non-automated sphygmomanometer as given in iso:proj:42914ISO 81060-1:2007 or invasive blood pressure monitoring equipment as given in iec:proj:105227IEC 60601-2-34. This document is not applicable to clinical performance verification of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.

 

Tässä standardissa esitetään yleiskäyttöön tarkoitetun ensiapulaukun sisältöä koskevat vaatimukset. Ensiapulaukku soveltuu mm. työpaikoille, kotiin tai mökille sekä ajoneuvoihin, joiden ensiapulaukun sisällöstä ei ole erikseen säädetty.Työpaikkojen ensiapuvalmiuteen kuuluvien ensiapuvälineiden tarkempi arviointi tehdään yrityskohtaisesti toimintaympäristöön,henkilöstömäärään sekä riskinarviointiin perustuen.

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