Toimialayhteisöt

 

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.

 

1.1 Scope of prEN 1992 1 2 (1) This document deals with the design of concrete structures for the accidental situation of fire exposure and is intended to be used in conjunction with prEN 1992 1 1 and EN 1991 1 2. This document identifies differences from, or supplements to, normal temperature design. (2) This document applies to concrete structures required to fulfil a loadbearing function, separating function or both. (3) This document gives principles and application rules for the design of structures for specified requirements in respect of the aforementioned functions and the levels of performance. (4) This document applies to structures, or parts of structures, that are within the scope of prEN 1992 1 1 and are designed accordingly. (5) The methods given in this document are applicable to normal weight concrete up to strength class C100/115 and lightweight concrete up to strength class LC50/60. 1.2 Assumptions (1) In addition to the general assumptions of prEN 1990 the following assumptions apply: - the choice of the relevant design fire scenario is made by appropriate qualified and experienced personnel or is given by the relevant national regulation; - any fire protection measure taken into account in the design will be adequately maintained.

 

1.1 Scope of FprEN 1992-1-1 (1) This document gives the general basis for the design of structures in plain, reinforced and prestressed concrete made with normal weight, lightweight and heavyweight aggregates. It gives specific rules for buildings, bridges and civil engineering structures, including temporary structures; additional requirements specific to bridges are given in Annex K. The rules are valid under temperature conditions between -40 °C and +100 °C generally. This document complies with the principles and requirements for the safety, serviceability, durability and robustness of structures, the basis of their design and verification that are given in EN 1990. (2) This document is only concerned with the requirements for resistance, serviceability, durability, robustness and fire resistance of concrete structures. Other requirements, e.g. concerning thermal or sound insulation, are not considered. (3) This document does not cover: - resistance to fire (see EN 1992 1 2); - fastenings in concrete (see EN 1992 4); - seismic design (see EN 1998 (all parts)); - particular aspects of special types of civil engineering works (such as dams, pressure vessels); - structures made with no-fines concrete, aerated or cellular concrete, lightweight aggregate concrete with open structure components; - structures containing steel sections considered in design (see EN 1994 (all parts)) for composite steel and concrete structures; - structural parts made of concrete with a smallest value of the upper sieve aggregate size Dlower < 8 mm (or if known Dmax < 8 mm) unless otherwise stated in this Eurocode. 1.2 Assumptions (1) The assumptions of EN 1990 apply to FprEN 1992-1-1. (2) It is assumed that the requirements for execution and workmanship given in EN 13670 are complied with.

 

This document provides terminology, concepts, requirements, and guidance for logging of AI systems. It is primarily intended for organizations placing on the market or putting into service AI systems and is not specific to any particular sector.

 

This document specifies requirements and guidance for the interoperability of data, data sharing mechanisms, and services within data spaces. It covers requirements, criteria and implementation guidance on: - dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty, and on machine-readable formats to find, access and use of data; - data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, and how to describe these elements a publicly available and consistent manner; - technical means to access the data, such as application programming interfaces, and their terms of use and quality of service to enable automatic access and transmission of data between parties; - where applicable, the means to enable the interoperability of tools for automating the execution of data sharing contracts. This document is applicable to all organizations participating in dataspaces, regardless of their size or type.

 

This document contains guidelines for developing and establishing policies and procedures for deletion of personally identifiable information (PII) in organizations by specifying:

—    a harmonized terminology for PII deletion;

—    an approach for defining deletion rules in an efficient way;

—    a description of required documentation;

—    a broad definition of roles, responsibilities and processes.

 

This document is intended to be used by organizations where PII is stored or processed.

 

This document does not address:

—    specific legal provision, as given by national law or specified in contracts;

—    specific deletion rules for particular clusters of PII that are defined by PII controllers for processing PII;

—    deletion mechanisms;

—    reliability, security and suitability of deletion mechanisms;

—    specific techniques for de-identification of data.

 

This document establishes a list of properties, and the corresponding test methods, that permit inspection and control of thermoset and thermoplastic composites.

 

This document contains guidelines for developing and establishing policies and procedures for deletion of personally identifiable information (PII) in organizations by specifying:

— a harmonized terminology for PII deletion;

— an approach for defining deletion rules in an efficient way;

— a description of required documentation;

— a broad definition of roles, responsibilities and processes.

 

This document is intended to be used by organizations where PII is stored or processed.

 

This document does not address:

— specific legal provision, as given by national law or specified in contracts;

— specific deletion rules for particular clusters of PII that are defined by PII controllers for processing PII;

— deletion mechanisms;

— reliability, security and suitability of deletion processes and mechanisms;

— specific techniques for de-identification of data.

 

This document specifies the test apparatus, test procedures, quality control and test report of swelling pressure test of buffer material for disposal of high-level radioactive waste. The swelling pressure of the buffer material is measured under constant volume conditions, which should be strictly maintained. This document is applicable to the measurement of swelling pressure of buffer material for disposal of high-level radioactive waste. The test should be performed at temperatures ranging from ambient to 95 °C. Higher test temperatures may be applied, provided that they are clearly documented in the test report and that all components of the test apparatus, including seals and sensors, are suitable for operation at the selected temperature. This document can also be applicable to test the swelling pressure of bentonite-based material for disposal of intermediate-level and low-level radioactive waste.

 

This International Standard provides requirements that are intended to minimize risks related to Electrical, Electronic and Electromechanical (EEE) parts used in commercial spacecraft, launch vehicles, and critical Ground Support Equipment (GSE). The family of EEE parts includes electro-optical parts. electrical, electronic and electromechanical (EEE) parts - and enhance safety and reliability.

 

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.

 

Tämä on muutos standardiin ISO/IEC 22237-2:2024 Information technology — Data centre facilities and  infrastructures — Part 2:  Building construction.

 

Alkuperäisen standardin soveltamisala on:

 

This document specifies requirements and recommendations for the construction of buildings and other  structures which provide accommodation for data centres based on the criteria and classification for  “physical security” within ISO/IEC 22237-1 in support of availability.
This document specifies requirements and recommendations for the following:
a) location and site selection (taking in to account natural environment and adjacencies);
b) protection from environmental risks;
c) site configuration;
d) building construction;
e) building configuration;
f) provision of access;
g) physical intrusion protection;
h) physical fire protection;
i) protection against damage from water;
j) quality construction measures.

 

Safety and electromagnetic compatibility (EMC) requirements are outside the scope of this document and  are covered by other standards and regulations. However, information given in this document can be of 
assistance in meeting these standards and regulations.

 

This document specifies a calculation method for the application of a static load test to the structural attachment of marine evacuation systems to ships.

 

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 specifies terms, general models, related parameters and various requirements of oblivious transfer.

 

This document specifies methods of measuring the effectiveness of inlet only, outlet only, and inlet/outlet anti-drain valves when fitted to a full-flow lubricating oil filter of the “spin-on” or “easy change” type, for internal combustion engines.

 

ISO 12625-8:2010 specifies a basket-immersion test method for the determination of water-absorption time and water-absorption capacity of tissue paper and tissue products. It is expressly stated that the detection of impurities and contraries in tissue paper and tissue products be applied according to ISO 15755. For the determination of moisture content in tissue paper and tissue products, ISO 287 is applicable.