Helsevesen, teknikk

Komité: CEN/TC 10 (Lifts, escalators and moving walks)
Opprinnelse:
Sluttdato: 25. jan 2018
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1.1 This European Standard deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility: - travelling over a stair or an accessible inclined surface; - intended for use by one person; - whose carriage is directly retained and guided by a guide rail or rails; - supported or sustained by rope (5.4.4), rack and pinion (5.4.5), chain (5.4.6), friction traction drive (5.4.7), and guided rope and ball (5.4.8). 1.2 The standard identifies hazards as listed in Clause 4 which arise during the various phases in the life of such equipment and describes methods for the elimination or reduction of these hazards when used as intended by the manufacturer. 1.3 This European standard does not specify the additional requirements for: - operation in severe conditions (e.g. extreme climates, strong magnetic fields); - operation subject to special rules (e.g. potentially explosive atmospheres); - handling of materials the nature of which could lead to dangerous situations; - use of energy systems other than electricity; - hazards occurring during manufacture; - earthquakes, flooding, fire; - evacuation during a fire; - stairlifts for goods only; - concrete, hardcore, timber or other foundation or building arrangement; - design of anchorage bolts to the supporting structure. NOTE For the actual type of machinery, noise is not considered a significant nor relevant hazard. 1.4 This document is not applicable to power operated stairlifts which are manufactured before the date of publication of this document by CEN.
Komité: CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
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Sluttdato: 25. jan 2018
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This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665 1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
Komité: ISO/TC 84 (Devices for administration of medicinal products and catheters)
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Sluttdato: 25. jan 2018
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Komité: ISO/TC 150 (Implants for surgery)
Opprinnelse:
Sluttdato: 20. feb 2018
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Komité: ISO/TC 173 (Assistive products for persons with disability)
Opprinnelse:
Sluttdato: 22. feb 2018
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Komité: ISO/TC 106/SC 2 (Prosthodontic materials)
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Sluttdato: 28. feb 2018
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Komité: CEN/TC 55 (Dentistry)
Opprinnelse:
Sluttdato: 1. mar 2018
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Komité: ISO/TC 106/SC 4 (Dental instruments)
Opprinnelse:
Sluttdato: 5. mar 2018
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Komité: CEN/TC 140 (In vitro diagnostic medical devices)
Opprinnelse:
Sluttdato: 7. mar 2018
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This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. CcfDNA profiles can change significantly after blood collection from the donor (e.g., release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Therefore, special measures have to be taken to secure good quality blood samples for ccfDNA examination and storage. Different dedicated measures need to be taken for preserving blood genomic DNA, which are not described in this International Standard. Blood genomic DNA is covered in ISO 20185-2, Molecular in vitro diagnostic examinations — specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA. NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes. Pathogen DNA present in blood is not covered by this International Standard. Different dedicated measures need to be taken for preserving DNA in circulating exosomes, which are not described in this International Standard. NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
Komité: ISO/TC 76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use)
Opprinnelse:
Sluttdato: 9. mar 2018
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