Palvelualojen työnantajat PALTA

 

 

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 requirements for the optical and geometrical properties of semi-finished blanks.

 

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

 

ISO 10322-1:2016 specifies requirements for the optical and geometrical properties of all semi-finished single-vision and multifocal spectacle lens blanks.

 

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 requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

 

This International Standard specifies the locations of coupling devices for electrical and pneumatic connections between towing and towed commercial road vehicles. It is applicable to heavy vehicles equipped with pneumatic braking systems and 24 V electrical equipment of the following types: drawbar-trailer combinations, centre-axle trailer combinations and multiple-vehicle combinations whose towing vehicles or trailers have rear-mounted couplings or couplings mounted forward and below, and articulated vehicles. This International Standard is not applicable to car carriers, or road vehicles equipped only with fully automatic coupling system (FACS) according to ISO 13044 not mounted on front of the trailer.

 

This document defines an API which standardizes the methods for diagnosing HPCs and legacy ECUs, the retrieval of the diagnostic capabilities, and the discovery of the SOVD methods in an extended vehicle. The SOVD API provides a unified access to classic ECUs and HPCs. The SOVD API provides functions such as: With these features SOVD can cover all areas of the vehicle life cycle which includes in particular Engineering (Development), Manufacturing (Production), After Sales (Maintenance and Repair), Legal and Technical inspections, and Vehicle operation (Use). There are several aspects which are not covered by this document, as they are specific to the implementation of an SOVD server, for example: This document considers the extended vehicle as defined in ISO20077 series. This means that the API or its elements can be inside or outside the physical vehicle.

 

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 examination results into the electronic medical record and other technical and management processes described in ISO 15189. The primary reason for risk management in medical laboratories is to reduce risk of harm to patients and identify opportunities for improved patient care. 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 complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

 

This document specifies a calculation method to determine the thermal transmittance of glass with flat and parallel surfaces. This document applies to uncoated glass (including glass with structured surfaces, e. g. patterned glass), coated glass and materials not transparent in the far infrared which is the case for soda lime glass products, borosilicate glass, glass ceramic, alkaline earth silicate glass and alumino silicate glass. It applies also to multiple glazing comprising such glasses and/or materials. It does not apply to multiple glazing which include in the gas space sheets or foils that are far infrared transparent. The procedure specified in this document determines the U value (thermal transmittance) in the central area of glazing. The edge effects due to the thermal bridge through the spacer of an insulating glass unit or through the window frame are not included. Furthermore, energy transfer due to solar radiation is not taken into account. The effects of Georgian and other bars are excluded from the scope of this document. Also excluded from the calculation methodology are any effects due to gases that absorb infrared radiation in the 5 to 50 µm range. The primary purpose of this document is product comparison, for which a vertical position of the glazing is specified. In addition, U values are calculated using the same procedure for other purposes, in particular for predicting: Reference can be made to [3], [4] and [5] or other European Standards dealing with heat loss calculations for the application of glazing U values determined by this standard. Reference can be made to [6] for detailed calculations of U values of glazing, including shading devices. Vacuum Insulating Glass (VIG) is excluded from the scope of this document. For determination of the U value of VIG, please refer to ISO 10291 or ISO 19916-1. A procedure for the determination of emissivity is given in ISO 20589. The rules have been made as simple as possible consistent with accuracy.

 

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 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.

 

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.

 

This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR). This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases. This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials. The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only. This document does not cover the step in which the user verifies a reagent (analysis method adoption). NOTE Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.

 

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

 

This document specifies requirements and recommendations for the provision of health and social care services for older persons provided by healthcare and social care personnel, irrespective of whether the service is provided in the persons own home or in a care home. The services concerned also include short term care e. g. respite care, enablement, and rehabilitation. Care services are provided in a variety of settings. While this document focuses on services provided in care facilities and care at home, including preventive, responsive, palliative and end of life care, many of the requirements and recommendations can be applied to the provision of care services in any setting. Service provision is based on the individual needs and preferences of the older person to assist self-determination, participation, safety, and security. The document encompasses the holistic needs of older persons receiving care at home and at care homes and the workforce, taking into consideration principles of equity, diversity, and inclusion. This document applies to all providers of care and support to older persons irrespective of size, structure, legal set up, or funding model (i.e., public, private or non-profit). Care homes, also referred to as residential care facilities, assisted living facilities, retirement homes/communities, are settings where the majority of older persons often live with complex care needs. They provide a range of professional health services, lodging, food, and personal care (e.g., assistance with everyday activities) for older persons 24 hours/day, 7 days a week. The document is structured to provide clear requirements and accountabilities to enable the workforce, governing bodies, and other stakeholders to work together toward a common vision for person-centred, high-quality care services for older persons. This document is intended to be used in quality assurance and improvement, follow-up, evaluation, and development of such services and can be used as a basis for procurement, training, supervision, and confirmation of level of achievement. This document does not cover standardization of clinical guidelines, medical devices and building codes (engineering and structural).

 

 

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire. NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C. NOTE 2        Respiratory therapy tubing is covered by ISO 17256. NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document. The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min). NOTE 4        There is rationale for this clause in A.2. The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.