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ISO/TC 69/SC 4/WG 11

  • prEN ISO 20126

    29-09-2017
    00055450

    Dentistry – Manual toothbrushes – General requirements and test methods

    Oprindelse:
    CEN
    International kategori
    Status
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  • EN ISO 20126:2012/prA1

    05-11-2013
    00055369

    Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012)

    Oprindelse:
    CEN
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  • prEN ISO 20166-1

    18-11-2015
    00140111

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA

    Oprindelse:
    CEN
    Status
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    This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities. The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the examination test results. RNA profiles in tissues can change drastically during collection and change differently in different tissue donors' / patients' tissues. Therefore, it is essential to take special measures to minimize the described RNA profile changes and modifications within the tissue for subsequent examination. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20166-2

    18-11-2015
    00140108

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins

    Oprindelse:
    CEN
    Status
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    This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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. This document is not applicable for protein examination by immunohistochemistry. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20166-3

    18-11-2015
    00140109

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA

    Oprindelse:
    CEN
    Status
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    This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities. DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles. These modifications of the DNA molecules can impact the validity and reliability of the examination test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA examination. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20170

    17-02-2015
    00290212

    Geometrical product specification (GPS) -- Decomposition of geometrical characteristics for manufacturing control

    Oprindelse:
    CEN
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    This Standard describes principles and tools to control a manufacturing process in accordance with a GPS specification. It establishes that the result of a GPS specification, consisting of one value, is not sufficient to control a manufacturing process. For this purpose it is necessary to use a set of one or more complementary, independent characteristics that correlate to the manufacturing process parameters. This Standard describes the concept of decomposition of the macro-geometrical part of the GPS specification. It does not cover the micro-geometry, i.e. surface texture. The objective of the decomposition presented in this standard is to define correction values for manufacturing control or to perform a statistical analysis of the process.
  • prCEN ISO/TR 20172 rev

    06-03-2018
    00121794

    Welding – Grouping systems for materials – European materials

    Oprindelse:
    CEN
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  • prCEN ISO/TR 20173 rev

    27-05-2015
    00121717

    Welding - Grouping systems for materials - American materials

    Oprindelse:
    CEN
    Status
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  • prEN ISO 20184-1

    18-11-2015
    00140112

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA

    Oprindelse:
    CEN
    Status
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    This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities. RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA examination. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20184-2

    18-11-2015
    00140113

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget
    Beskrivelse
    This International Standard recommends the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of extracted proteins during the pre-examination phase before a molecular assay is performed. 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 organisations performing biomedical research, biobanks, and regulatory authorities. Protein profiles and protein-protein interactions in tissues can change drastically before tissue collection (e.g., due to warm ischemia) and after tissue collection (e.g., due to cold ischemia). The changes are caused by e.g., gene induction, gene down regulation, protein degradation. Protein species amounts can change differently in different donors’ / patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environmental conditions after the tissue removal from the body. Therefore, it is essential to take special measures to minimize the described protein profile changes and modifications within the tissue for subsequent examination. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable to protein examination by immunohistochemistry. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20186-1

    18-11-2015
    00140105

    Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for blood – Part 1: Isolated cellular RNA

    Oprindelse:
    CEN
    Status
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    This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA 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. Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage. Different dedicated measures need to be taken for stabilising blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this International Standard. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this International Standard. RNA in pathogens present in blood is not covered by this International Standard. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20186-2

    18-11-2015
    00140107

    Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for blood – Part 2: Isolated genomic DNA correct

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget
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    This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis 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 (e.g., medical laboratories. It is also intended to be used by, laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizsations performing biomedical research, biobanks, and regulatory authorities). Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysisexamination. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures have to be taken for preserving blood cell free circulating DNA, which are not described in this International Standard. Circulating cell free DNA in blood is covered in ISO 20091-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizsing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this International Standard. Pathogen DNA present in blood is not covered by this International Standard. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
  • prEN ISO 20186-3

    18-11-2015
    00140106

    Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget
    Beskrivelse
    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.
  • prEN ISO 20227

    24-03-2015
    00230335

    Water quality - Determination of the growth inhibition effects of waste waters, natural waters and chemicals on the duckweed Spirodela polyrhiza - Method using a stock culture independent microbiotest

    Oprindelse:
    CEN
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    This International Standard specifies a method for the determination of the inhibition of the growth of the first fronds of Spirodela polyrhiza germinated from dormant turions, by substances and mixtures contained in water or waste water, including treated municipal waste water and industrial effluents. The test is also applicable to pure chemicals and in particular plant protection products and pesticides.
  • prEN ISO 20238

    18-05-2015
    00188094

    Conveyor belts - Drum friction testing

    Oprindelse:
    CEN
    Status
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    This European Standard describes a method of test to determine the propensity of a conveyor belt to generate heat flame or glow when held stationary under a given tension, in surface contact around a rotating driven steel drum. Means of varying the belt tension are described. NOTE – For certain belt types, due to their construction, it may not be possible to conduct this test due to the inability of the belt to comply with the requirements of 6.2.3.
  • prEN ISO 20257-1

    26-01-2016
    00282026

    Installation and equipment for liquefied natural gas -- Design of offshore installations -Part 1: General requirements for floating LNG installations

    Oprindelse:
    CEN
    Status
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    The objective of ISO 20257-1 is to provide functional guidelines and recommend practices for the design of floating liquefied natural gas (LNG) installations in order to have a safe and environmentally acceptable design and operation of floating LNG installations. ISO 20257 gives functional guidelines for the design and operation of all floating LNG installations including those for the liquefaction, storage, vaporisation, transfer and handling of LNG.
  • prEN ISO 20274

    02-09-2015
    00262301

    Vitreous and porcelain enamels — Preparation of enamelled samples and determination of thermal expansion coefficient

    Oprindelse:
    CEN
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    This standard specifies the procedures for the preparation of enamel samples for measurement of the thermal dilatation and calculation of the thermal expansion coefficient.
  • prEN ISO 20361

    15-01-2016
    00197092

    Liquid pumps and pump units - Noise test code - Grades 2 and 3 of accuracy

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget
  • prEN ISO 20380

    20-01-2015
    00136372

    Public swimming pools - Computer vision systems for the detection of drowning accidents in swimming pools - Safety requirements and test methods

    Oprindelse:
    CEN
    Status
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    This European standard should describe the general safety requirements and test methods for computer vision systems used to detect drowning accidents in swimming pools. This standard would not apply to the systems used in domestic swimming pools and pools with a surface area of less than 150 m2.
  • ISO/NP TR 20413

    14-10-2015
    067934

    Fire safety engineering -- Survey of performance-based safety design practices in different countries

    Oprindelse:
    ISO
    Status
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  • prCEN ISO/TR 20416

    07-11-2017
    JT003052

    Medical devices – Post-market surveillance for manufacturers

    Oprindelse:
    Emner
    Status
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    The proposed Technical Report is to provide a common understanding of post-market surveillance, or PMS facilitating international cooperation in this area. The Technical Report is intended for use by manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices. The proposed Technical Report aims to describe a comprehensive data collection process and activities that allow characterization of the behavior of the devices as used in practice, and identify necessary and/or possible actions. PMS information may include material that requires reporting to Regulatory Authorities. The proposed Technical Report will not provide information for such reporting, nor for achieving compliance with any other (PMS) requirement by Regulatory Authorities. Market surveillance by national authorities, as well as actions legally required to be performed by manufacturers as part of PMS or vigilance are outside the scope of the proposed Technical Report. The document is not intended to replace or change national or regional legislation on PMS.
  • prEN ISO 20430

    02-12-2014
    00145076

    Plastics and rubber machines - Injection moulding machines - Safety requirements

    Oprindelse:
    CEN
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    This standard specifies the essential safety requirements for the design, construction and use of injection moulding machines for the processing of plastics and/or rubber.
  • prCEN ISO/TS 20440

    01-07-2015
    00251317

    Health informatics -- Identification of medicinal products -- Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

    Oprindelse:
    CEN
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  • prCEN ISO/TS 20443

    01-07-2015
    00251318

    Health informatics — Identification of Medicinal Products -- Implementation Guide for ISO 11615 Data elements and structures for the unique identification and exchange of regulated medicinal product information

    Oprindelse:
    CEN
    Status
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  • prCEN ISO/TS 20451

    01-07-2015
    00251319

    Health informatics -- Identification of medicinal products -- implementation guide for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget