Hälso- och sjukvård

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 3 mar 2018
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This European Standard specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.

These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices.

This European Standard specifies minimum requirements

• for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;

• for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;

• for the test equipment and test procedures used to verify the sterilizer performance specified by this European Standard.

This European Standard does not specify requirements for equipment intended to process liquids, biological waste or human tissues.

This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.

This European Standard does not specify requirements and tests for decontamination systems for use in rooms, enclosures or environmental spaces.

NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.

NOTE 2 Environmental aspects of this standard are addressed in Annex H.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 4 mar 2018
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This International Standard defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry. It is noted that the challenge in the creation of cross referenceable datasets lies with the definition and consistent application of a basic dataset and this standard may provide the initial list for tracking, however, in order support for instance retrieval analysis, a more extensive dataset may be required.

This International Standard is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

This International Standard is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.

It is not the intent of this International Standard to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

NOTE Users of this International Standard are reminded to apply appropriate national standards or regulations concerning data protection and handling.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 13 mar 2018
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This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 19 mar 2018
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This document recommends the handling, storage, processing and documentation 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 document covers specimens collected in venous whole blood collection tubes.

This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Different dedicated measures need to be taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2, Molecular in vitro diagnostic examinations — specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA.

Different dedicated measures need to be taken for preserving DNA in circulating exosomes, which are not described in this document.

NOTE 1 CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes[8][9].

DNA in pathogens present in blood is not covered by this document.

NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 7 apr 2018
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This document defines terms applicable to intraocular lenses and to the methods used to evaluate them.

Kommittébeteckning: SIS/TK 504 (e-Tillgänglighet)
Källa: CEN
Svarsdatum: den 1 maj 2018
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The present document specifies the functional accessibility requirements applicable to ICT products and services, together with a description of the test procedures and evaluation methodology for each accessibility requirement in a form that is suitable for use in public procurement within Europe. The present document might be useful for other purposes such as procurement in the private sector.

The relationship between the present document and the essential requirements of Directive 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies [i.28] is given in Annex A.

The present document contains the necessary functional requirements and provides a reference document such that if procedures are followed by different actors, the results of testing are similar and the interpretation of those results is clear. The test descriptions and evaluation methodology included in the present document are elaborated to a level of detail compliant with ISO/IEC 17007:2009 [i.14], so that conformance testing can give conclusive results.

All clauses except those in clause 12, related to documentation and support services, are self-scoping. This means they are introduced with the phrase 'Where ICT <pre-condition>'. Compliance is achieved either when the pre-condition is true and the corresponding test (in Annex C) is passed, or when the pre-condition is false (i.e. the pre-condition is not met or not valid).

NOTE 1: Compliance issues are covered in normative clause C.1.

The inherent nature of certain situations makes it impossible to make reliable and definitive statements that accessibility requirements have been met. In those situations therefore, the requirements in the present document are not applicable:

• when the product is in a failure, repair or maintenance state where the ordinary set of input or output functions are not available;

• during those parts of start-up, shutdown, and other state transitions that can be completed without user interaction.

NOTE 2: Even in the above situations, it