Esileht»Infoteenus

11 TERVISEHOOLDUS

Tagasi peagrupi juurde

Uued standardid


EVS-EN ISO 15747:2019
Hind 11,67 EUR
Identne ISO 15747:2018; EN ISO 15747:2019
Veenisisesteks süstideks mõeldud plastanumad
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

EVS-EN 17161:2019
Hind 18,00 EUR
Identne EN 17161:2019
Design for All - Accessibility following a Design for All approach in products, goods and services - Extending the range of users
This document specifies requirements that enable an organization to design, develop and provide products, goods and services so that they can be accessed, understood and used by the widest range of users, including persons with disabilities. This document specifies requirements and recommendations that enables an organization to extend their range of users by identifying diverse needs, characteristics, capabilities, and preferences, by directly or indirectly involving users, and by using knowledge about accessibility in its procedures and processes. This document specifies requirements that can enable an organization to meet applicable statutory and regulatory requirements as related to the accessibility of its products, goods and services. The requirements set out in this document are generic and are intended to be applicable to all relevant parts of all organisations, regardless of type, size or products, goods and services provided. This document promotes accessibility following a Design for All approach in mainstream products goods and services and interoperability of these with assistive technologies. This document does not provide technical design specifications and does not imply uniformity in design or functionality of products, goods and services.

EVS-EN IEC 62464-1:2019
Hind 22,15 EUR
Identne IEC 62464-1:2018; EN IEC 62464-1:2019
Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
This part of IEC 62464 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for - quality assessment in the ACCEPTANCE TEST, and - quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address - image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated, - image quality affected by MR-compatibility issues, - special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and - TYPE TESTS. The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images. The measurement procedures specified in this document are directed to - MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document, - test houses, who can confirm performance of MR EQUIPMENT using methods described in this document, - regulatory authorities, who can reference this document, and - RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document. The essential image quality parameters and measurement methodologies defined in this document are - SIGNAL TO NOISE RATIO, - UNIFORMITY, - SLICE THICKNESS in 2-D scanning, - 2-D GEOMETRIC DISTORTION, - SPATIAL RESOLUTION, and - GHOSTING ARTEFACTS. Each of these procedures can be performed standalone or in combination with any of the other procedures. This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT. NOTE None of the methods found in this document have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.

EVS-EN ISO 7886-4:2019
Hind 9,49 EUR
Identne ISO 7886-4:2018; EN ISO 7886-4:2019
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)
This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

ISO 20498-1:2019
Hind 51,61 EUR
Traditional Chinese medicine -- Computerized tongue image analysis system -- Part 1: General requirements
This document specifies general requirements for a computerized tongue image analysis system (CTIS). This document is limited to the safety aspects and technical requirements for a CTIS, excluding the diagnosis or interpretation of tongue images.

ISO 24508:2019
Hind 78,30 EUR
Ergonomics -- Accessible design -- Guidelines for designing tactile symbols and characters
This document provides design guidelines and requirements for tactile symbols and characters used for information and marking for people who need non-visual or non-auditory information. It is applicable to products, facilities and equipment in housing and transportation, services and packaging, where tactile symbols and characters may be used. This document specifies the physical characteristics of tactile symbols and characters for ease of legibility by touch taking into account human abilities of tactile sense and their aging effect. It does not specify semantic characteristics of tactile symbols and characters. This document is applicable to tactile symbols and characters of convex-type touched by fingers. It is not applicable to specifically coded tactile symbols or characters such as those of Braille, nor to those with vibratory or temporal changes.

ISO 21300:2019
Hind 51,61 EUR
Traditional Chinese medicine -- Guidelines and specification for Chinese materia medica
This document specifies the general requirements for Chinese materia medica specification. This specification is relevant for dividing Chinese materia medica into categories. It provides guidelines for writing the specifications of individual Chinese materia medica.

ISO 22212:2019
Hind 78,30 EUR
Traditional Chinese medicine -- Gastrodia elata tuber
This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

Asendatud või tühistatud standardid


EVS-EN 62464-1:2007
Identne IEC 62464-1:2007; EN 62464-1:2007
Magnetic resonance equipment for medical imaging -- Part 1: Determination of essential image quality parameters
This international standard specifies measurement procedures for the determination of many essential medical MR EQUIPMENT image quality parameters. Measurement procedures as addressed in this standard are suitable for: - quality assessment in the ACCEPTANCE TEST; - quality assurance in the CONSTANCY TEST. In addition, the measurement procedures specified in this standard may also be useful for type tests, although that is not an objective of this standard.
Keel: Inglise

EVS-EN ISO 7886-4:2009
Identne ISO 7886-4:2006; EN ISO 7886-4:2009
Steriilsed nahaalusteks süsteteks ettenähtud ühekordselt kasutatavad süstlad. Osa 4: Korduskasutuse välistatusega süstlad
This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
Keel: Inglise

EVS-EN ISO 15747:2011
Identne ISO 15747:2010; EN ISO 15747:2011
Veenisisesteks süstideks mõeldud plastanumad (ISO 15747:2010)
This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
Keel: Inglise

Kavandite arvamusküsitlus


EN ISO 8596:2018/prA1
Identne ISO 8596:2017/DAmd 1; EN ISO 8596:2018/prA1
Tähtaeg 15.05.2019
Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation - Amendment 1 (ISO 8596:2017/Damd1:2019)
Amendment for EN ISO 8596:2018
Keel: Inglise

EN ISO 24157:2008/prA1
Identne ISO 24157:2008/DAmd 1; EN ISO 24157:2008/prA1
Tähtaeg 15.05.2019
Ophthalmic optics and instruments - Reporting aberrations of the human eye - Amendment 1 (ISO 24157:2008/DAmd 1:2019)
Amendment for EN ISO 24157:2008
Keel: Inglise

prEN ISO 1942
Identne prEN ISO 1942; ISO/DIS 1942:2019
Tähtaeg 15.05.2019
Dentistry - Vocabulary (ISO/DIS 1942:2019)
This document provides a selective vocabulary of terminological concepts used for the development of dental product standards in the interest of facilitating the standard development process and comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in the field of standardization.
Keel: Inglise