Ämnesområden

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

This document defines basic terms, symbols, and units of measurement for the field of laser technology in order to unify the terminology and to arrive at clear definitions and reproducible tests of beam parameters and laser-oriented product properties. NOTE The laser hierarchical vocabulary laid down in this document differs from that given in IEC 60825?1. ISO and IEC have discussed this difference and agree that it reflects the different purposes for which the two standards serve. For more details, see informative Annex A.

ISO 12052:2017, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information. ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying: - for network communications, a set of protocols to be followed by devices claiming conformance to this document; - the syntax and semantics of Commands and associated information which can be exchanged using these protocols; - for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media; - information that is to be supplied with an implementation for which conformance to this document is claimed. ISO 12052:2017 does not specify: - the implementation details of any features of the DICOM standard on a device claiming conformance; - the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document; - a testing/validation procedure to assess an implementation's conformance to this document. ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field. ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments. ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator's stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

This document specifies a method for the determination of arsenic content in crude oil using atomic fluorescence spectrometry. Microwave digestion is used for pre-treatment of the oil sample into an inorganic solution.

This document provides a self-assessment of an organization’s human-centred design principles, processes, and activities throughout the life cycle of computer-based interactive systems, It also provides an overview of information given in the ISO 9241-200 series. It is intended to be used as an introduction and self-assessment guide to human-centred design (HCD). Its target audience are personnel responsible for and managing design processes, and it is concerned with ways in which both hardware and software components of interactive systems can enhance human–system interaction. It includes a self-assessment that allows organizations to understand and assess their level of awareness and practices with respect to the human-centred design approach and best practices for organizations and project teams within that organization. This document does not provide detailed coverage of the methods and techniques required for human-centred design, nor does it address health or safety aspects in detail. Although it addresses the planning and management of human-centred design, it does not address all aspects of project management. Detailed human factors/ergonomics, usability and accessibility issues are dealt with more fully in a number of standards including other parts of ISO 9241and ISO 6385, which sets out the broad principles of ergonomics.

ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

ISO/IEC 17024:2012 contains principles and requirements for a body certifying persons against specific requirements, and includes the development and maintenance of a certification scheme for persons.

 I detta dokument anges krav för typer av blåst glas utifrån glasets tjocklek.

This document specifies the definitions and requirements for solid-wall pipes with or without internal skin and smooth internal and external surfaces extruded from the same compound throughout the wall, fittings and the system of polyethylene (PE) piping systems to be intended for use in non-pressure underground drains and sewers for foul wastewater.

NOTE 1 Products complying with this document can also be used in non-pressure underground drains and sewers for surface water.

This document is applicable to:

a) non-pressure drains and sewers, which are intended to be used buried underground outside the building structure; reflected in the marking of products by “U”;

b) non-pressure drains and sewers, which are intended to be used buried underground both outside (application area code “U”) and within the building structure, reflected in the marking of products by “UD”.

This document specifies test methods referred to in this document and test parameters.

This document is applicable to pipes and fittings with or without an integral socket.

This document covers a range of pipe and fitting sizes, stiffness classes, tolerance classes and gives recommendations concerning colours.

NOTE 2 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

In conjunction with CEN/TS 12666-2 [1] it is applicable to PE pipes and fittings, their joints and to joints with components of other plastics and non-plastics materials intended to be used for buried piping systems for non-pressure drains an sewers.

The fittings can be manufactured by injection moulding or can be fabricated from pipes and/or mouldings.

This document is applicable to PE pipes and fittings for the following types of joints:

— elastomeric ring seal joints;

— butt fused joints;

— electrofusion joints;

— mechanical joints.

NOTE 3 Pipes, fittings and other components conforming to any of the plastics product standards listed in the Annex D (informative) can be used with pipes and fittings conforming to this document, provided they conform to the requirements for joint dimensions given in Clause 7 and to the requirements of Clause 7 and Table 13.

This document specifies a method for the enumeration of culturable microorganisms in water by counting the colonies on a low-nutrient agar culture medium after incubation at 22 °C for 7 d. The method is intended to measure the operational efficiency of the treatment process of public drinking water supplies, including the water in distribution systems and containers. The method is particularly suitable to monitor water for human consumption which is low in nutrients and is distributed in temperatures below 20 °C. The method can be applied to all types of water, including pool and spa waters. NOTE 1 The low-nutrient agar in use in this document usually gives higher colony counts from water samples than nutrient-rich formulations of culture media typically used for enumeration of culturable microorganisms. NOTE 2 The method is also applicable for waters of very low nutrient content such as de-ionised, distilled or reverse osmosis waters. NOTE 3 This document describes the use of R2A medium. There are other formulations available, e.g. R3A medium that might be suitable for certain applications but go beyond the scope of this document.

This European Standard specifies the requirements for the digital automatic coupler (DAC) for freight compliant with the Technical Specification relating to the subsystem ‘rolling stock — freight wagons’ of the rail system in the European Union Commission Regulation (EU) No 321/2013 of 13 March 2013 and repealing Decision 2006/861/EC and EU regulation 2019/776. Commission Regulation (EU) No 1302/2014 of 18 November 2014 concerning a technical specification for interoperability relating to the ‘rolling stock — locomotives and passenger rolling stock’. This standard specifies the minimum interface requirements to allow automatic coupling (mechanical and pneumatic) of two digital automatic couplers. The standard further specifies the mechanical interfaces needed for the interoperability of electrical couplers. It does not cover the electrical contacts needed. The standard covers the requirements for DACs integrated into locomotives. Coupler-to-coupler interfaces for the Hybrid coupler solutions will be covered in this standard. All non-mechanical interfaces such as the digital and electrical requirements needed for the DAC are defined in the scope of CENELEC/TC9X/WG 15-10.

This document specifies the requirements for declaration and verification of vibration emission values of continuous, frequency-weighted and repeated shock vibrations. It applies to hand-arm and whole-body vibration values achieved by measurements according to type-B and type-C standards. It - gives guidance on the declaration of vibration emission values, - describes vibration and product information to be given in the instruction for use supplied with the machinery, - specifies the method for verifying the declared vibration emission values stated in the instruction for use of the machinery.

This document describes a method of determining the hole expansion ratio in metallic sheets and strips with a thickness range of 1,2 mm to 6,0 mm inclusive and a width of at least 90 mm. NOTE This test is normally applicable to sheet metal and is used to assess the suitability of the product for forming flanges.

This document deals with whole body vibration as a significant hazard. It also specifies the methods for determining the vibration emission transmitted to the whole body of drivers standing and/or seated on freely moveable GSE, when driving for purposes of type evaluation, declaration and methods of verifying vibration emission. The test results are not applicable to the determination of whole body vibration exposure of persons.

ISO 10896-2:2016 specifies general safety requirements for slewing rough-terrain variable-reach trucks (hereafter known as "trucks"), consisting of a lower chassis with a slewing upper structure equipped with a telescopic lifting means (pivoted boom), on which a load handling device (e.g., carriage and fork arms) is typically fitted. Fork arms and other integrated attachments are considered to be parts of the truck. Other standards, in addition to the relevant provisions of this part of ISO 10896, can apply to the attachments. ISO 10896-2:2016 is not applicable to the following: a) rough terrain variable-reach trucks covered by ISO 10896‑1 (non-slewing); b) industrial variable-reach trucks covered by ISO 3691‑2; c) mobile cranes; d) machines designed primarily for earth-moving, such as loaders, even if their buckets are replaced by fork arms (see ISO 20474); e) trucks designed primarily with variable-length load suspension elements (e.g. chain, ropes) from which the load may swing freely in all directions; NOTE Additional requirements for trucks intended for freely swinging load applications, their lifting devices and attachments, and personnel/work platform applications on trucks, are being developed by ISO/TC 110/SC4. f) trucks designed primarily for container handling. The significant hazards covered by this part of ISO 10896 are listed in Annex A. This part of ISO 10896 does not address hazards that can occur - during manufacture, - when handling suspended loads, which may swing freely, - when lifting personnel, - when using trucks on public roads, - when operating in potentially explosive atmospheres, or - with a battery, LPG or hybrid as the primary power source.

This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging. This document applies to operating lights, irrespective of the technology of the light source. This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.

This document describes a systematic approach to assess potential occupational risks related to the dermal exposure to chemical agents at the workplace. This approach provides guidance to identify hazards, exposure routes, exposed body parts and potential consequences of exposure with respect to skin uptake and local skin effects, using qualitative and quantitative approaches. NOTE There is a relation between skin contamination and inadvertent ingestion. This document is aimed at occupational hygienists, researchers and other safety professionals to assist recognition of potential dermal exposure and its potential consequences.

This document describes the conditioning procedures for test specimens which will be tested according to the European standards for reaction to fire. The rules for the selection of substrates for construction products when carrying out reaction to fire tests are also detailed in this document. This document does not contain requirements for - the pre-drying of test specimens for the non-combustibility test according EN ISO 1182; - methods of cleaning (e.g. washing) and other methods for the assessment of durability aspects, which are dealt with in the relevant product standards.

This document specifies definitions, principles of construction (but not dimensions) and design, requirements on performance and operation as well as methods for testing the performance of adjustable chemical dosing systems for conditioning water intended for human consumption inside buildings (see [1]) which are permanently connected to the mains supply.