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ISO/TC 69/SC 4/WG 11

  • prEN ISO 10848-3 rev

    01-09-2014
    00126129

    Acoustics - Laboratory measurement of the flanking transmission of airborne and impact sound between adjoining rooms - Part 3: Application to light elements when the junction has a substantial influence

    Oprindelse:
    CEN
    Status
    Forslag om nyt arbejdsemne vedtaget
  • prEN ISO 10848-4 rev

    01-09-2014
    00126130

    Acoustics - Laboratory measurement of the flanking transmission of airborne and impact sound between adjoining rooms - Part 4: Application to junctions with at least one heavy element

    Oprindelse:
    CEN
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  • prEN ISO 10893-6 rev

    18-09-2015
    EC110231

    Non-destructive testing of steel tubes -- Part 6: Radiographic testing of the weld seam of welded steel tubes for the detection of imperfections

    Oprindelse:
    CEN
    Status
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  • prEN ISO 10893-7 rev

    18-09-2015
    EC110232

    Non-destructive testing of steel tubes -- Part 7: Digital radiographic testing of the weld seam of welded steel tubes for the detection of imperfections

    Oprindelse:
    CEN
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  • prEN ISO 10993-1 rev

    27-05-2015
    00206070

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    Oprindelse:
    CEN
    Status
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  • prEN ISO 10993-10 rev

    09-05-2018
    00206086

    Biological evaluation of medical devices – Part 10: Tests for skin sensitization

    Oprindelse:
    CEN
    Emner
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  • prEN ISO 10993-15 rev

    27-05-2015
    00206072

    Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

    Oprindelse:
    CEN
    Status
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  • prEN ISO 10993-16 rev

    27-05-2015
    00206073

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

    Oprindelse:
    CEN
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  • prEN ISO 10993-18 rev

    27-05-2015
    00206074

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials

    Oprindelse:
    CEN
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  • ISO/NP TS 10993-19

    09-12-2014
    064751

    Biological evaluation of medical devices-- Part 19: Physico-chemical, morphological and topographical characterization of materials

    Oprindelse:
    ISO
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  • ISO/NP TS 10993-20

    09-12-2014
    068938

    Biological evaluation of medical devices-- Part 20: Principles and methods for immunotoxicology testing of medical devices

    Oprindelse:
    ISO
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  • prEN ISO 10993-5 rev

    10-09-2013
    00206067

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

    Oprindelse:
    CEN
    Emner
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  • prEN ISO 10993-7 rev

    06-08-2013
    00206066

    Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

    Oprindelse:
    CEN
    Emner
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  • prEN ISO 10993-9 rev

    27-05-2015
    00206071

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

    Oprindelse:
    CEN
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  • prEN ISO 11058 rev

    12-02-2016
    00189256

    Geotextiles and geotextile-related products - Determination of water permeability characteristics normal to the plane, without load

    Oprindelse:
    CEN
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  • prEN ISO 11073-00103

    20-05-2015
    00251314

    Health informatics -- Personal health device communication -- Part 00103: Overview

    Oprindelse:
    CEN
    Status
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    Beskrivelse
    Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.
  • prEN ISO 11073-10404 rev

    24-05-2014
    00251299

    Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter

    Oprindelse:
    CEN
    Emner
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  • FprEN ISO 11073-10417 rev

    28-01-2016
    00251328

    Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter

    Oprindelse:
    CEN
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  • prEN ISO 11073-10441

    20-05-2015
    00251311

    Health informatics -- Personal health device communication -- Part 10441: Device specialization -- Cardiovascular fitness and activity monitor

    Oprindelse:
    CEN
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    Beskrivelse
    Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal cardiovascular fitness and activity monitoring devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices. In this context, cardiovascular fitness and activity monitor devices are being used broadly to cover cardiovascular fitness and activity monitor devices that measure physical actions and the body’s various physiological responses to that activity.
  • prEN ISO 11073-10442

    20-05-2015
    00251315

    Health informatics -- Personal health device communication -- Part 10442: Device specialization -- Strength fitness equipment

    Oprindelse:
    CEN
    Status
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    Beskrivelse
    Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between personal strength fitness devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth strength fitness devices. In this context, strength fitness devices are being used broadly to cover strength fitness devices that measure musculo-skeletal strength-conditioning activities.
  • prEN ISO 11073-10471 rev

    24-05-2014
    00251300

    Health informatics - Personal health device communication - Part 10471: Device specialization - Independant living activity hub

    Oprindelse:
    CEN
    Emner
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  • prEN ISO 11073-20201

    23-09-2005
    00251205

    Archetype Knowledge Framework

    Oprindelse:
    CEN
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    Beskrivelse
    The prEN13606-1 Reference Model standardizes the communication of EHR instance data,permitting EHRs to be exchanged. Due to naming and meaning attributes in the ReferenceModel these EHR_EXTRACTS will be syntactically interoperable (i.e their structure andprovenance can be understood) and semantically interpretable (i.e. the semantics is explicitand can be analyzed) but not semantically interoperable (i.e. 13606 alone does not guaranteethat different EHR systems and vendors will construct equivalent EXTRACTS, and use therecord hierarchy and terminology in consistent ways). Ensuring EHR data quality and dataconsistency are beyond its scope.The prEN13606-2 Archetype Interchange Specification standardizes the communication ofarchetypes – permitting archetypes to be exchanged between registries and EHR systems,but does not define how archetypes can be designed optimally for each clinical area, orconsistently across authoring teams.However, in order to be able to process and analyse health records inside any one systemthat originate from heterogeneous record sources, we need rich semantic interoperability. Weneed consistent and rigourous archetypes that standardise the clinical content of EHREntries, for use by clinical applications, within messages, for decision support, public healthand research.The following ingredients are still required in order for semantic interoperability to beachieved:1) an archetype ontology to map individual archetypes to a generic knowledge framework – toenable their use alongside other knowledge resources;2) Domain Base Concept Models (DBCMs), enabling sharable archetypes to be written;These models are needed to underpin the development of optimal and consistent archetypes.The openEHR Entry specialisations are well-tailored examples of this, but a variety of CENstandards (CONTSYS, HISA and GPICs) and EHR system models should be investigated foruse.3) rules about binding co-ordinated terminology values to archetype nodes
  • prEN ISO 11117

    13-10-2015
    00023194

    Gas cylinders - Valve protection caps and valve guards - Design, construction and tests

    Oprindelse:
    CEN
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  • prEN ISO 11121

    09-12-2015
    00329019

    Recreational diving services - Requirements for introductory training programmes to scuba diving

    Oprindelse:
    CEN
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    Beskrivelse
    This International Standard specifies minimum requirements for training organizations that offer introductory scuba experience training programmes to individuals without prior diver training. This International Standard applies to programmes that include participants being taken into an open water environment. It does not apply to programmes that are exclusively conducted in a confined water environment (e.g. swimming pools). This International Standard also specifies the conditions under which this service is to be provided, which supplement the general requirements for recreational diving services specified in ISO 24803.
  • prEN ISO 11124-1 rev

    24-05-2014
    00139521

    Preparation of steel substrates before application of paints and related products - Specifications for metallic blast-cleaning abrasives - Part 1: General introduction and classification

    Oprindelse:
    CEN
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