Palvelualojen työnantajat PALTA

 

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).

 

 

ISO 18739:2016 specifies terms, synonyms for terms and definitions used in the process chain for CAD/CAM systems in dentistry.

 

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.

 

This document specifies dimensions required for the installation and integration of the high pressure fuel pump in gasoline (GDI) engines. The location of the fuel connections and the dimensions of the pump outside shape are not defined since they vary according to the manufacturer of the pump and to the application.

 

 

This document specifies methods of determining the luminous and solar characteristics of glazing in buildings. These characteristics can serve as a basis for lighting, heating and cooling calculations of rooms and permit comparison between different types of glazing. This document applies both to conventional glazing and to absorbing or reflecting solar-control glazing, used as vertical or horizontal glazed apertures. The appropriate formulae for single, double and triple glazing are given. A matrix method is provided as an alternative calculation method. This document introduces a method to determine the luminous and solar properties of Building-Integrated Photovoltaic (BIPV) glazing. This document is accordingly applicable to all transparent materials except those which show significant transmission in the wavelength region 5 µm to 50 µm of ambient temperature radiation, such as certain plastic materials. Materials with light-scattering properties for incident radiation are dealt with as conventional transparent materials subject to certain conditions (see 5.3). Angular light and solar properties of glass in building are excluded from this document. However, research work in this area is summarised in[1],[2] and[3]. Guidance on the measurement of luminous and spectral properties of glass can be found in[4]. Vacuum Insulating Glass (VIG) is excluded from the scope of this document. For determination of the g value of VIG, please refer to ISO 19916-1.

 

ISO 8980-4:2006 specifies optical and non optical requirements, including durability, and test methods for anti-reflective coatings on spectacle lenses. ISO 8980-4:2006 does not deal with the following topics: transmittance and absorbtance; the colour of the reflected light.

 

This part of ISO 3630 specifies requirements and test methods for the accuracy of electronic apex locators that are used to determine the apical foramen (‘apex’ in this document) location during endodontic treatment. Integrated types of electronic apex locators are excluded from this standard.

 

 

This document provides guidance and considerations for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows: This document does not apply to the details for providing pandemic response medical tests such as the specimen collection protocols in the specimen collection units or screening stations (e.g., Walk-through or Drive-through), experiment procedures, and quality management systems of medical laboratories. Also, this document omits the pandemic responses related to the medical treatment of infected patients in the care units (e.g., emergency unit, in-patient unit) and transferring of confirmed patients in the healthcare organization during a pandemic.

 

This part of ISO 8980 specifies optional requirements and test methods for anti-reflective and hydrophobic coating properties on spectacle lenses. This part of ISO 8980 does not deal with the following topics: