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  • ISO/NP 8536-12

    26-01-2016
    070731

    Infusion equipment for medical use-- Part 12: Check valves

    Oprindelse:
    ISO
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    Forslag om nyt arbejdsemne vedtaget
  • ISO/NP 11595

    22-08-2007
    11595

    Health informatics - Pharmacovigilance - Controlled vocabularies for laboratory test units for the reporting of laboratory results

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  • ISO/NP 13018

    24-07-2012
    13018

    Implants for surgery - Evaluation of in vivo bone formation in porous materials

    Oprindelse:
    ISO
    Emner
    Status
    Project to be redefined
  • ISO/NP 13019

    24-07-2012
    13019

    Implants for surgery - Quantification of sulphated glycosaminoglycans (sGAG) for evaluation of chondrogenesis

    Oprindelse:
    ISO
    Emner
    Status
    Project to be redefined
  • ISO/NP 13670

    31-03-2009
    13670

    Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-Tricalcium phosphate bone substitutes

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  • ISO/NP 14708-4

    30-09-2011
    14708-4

    Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps

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  • ISO/NP 14708-4

    27-03-2017
    073537

    Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps

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    ISO
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  • ISO/NP 15901-2

    18-12-2017
    067586

    Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption -- Part 2: Analysis of nanopores by gas adsorption

    Oprindelse:
    ISO
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  • ISO/NP TR 16947

    04-04-2011
    16947

    Guidance on the application of ISO 14971

    Oprindelse:
    ISO
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    Komite
  • ISO/NP 17587

    08-07-2011
    17587

    In vitro diagnostics - Nucleic acid-based in vitro diagnostics for detection and identification of microbial pathogens - General requirements and definitions

    Oprindelse:
    ISO
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Komite
  • ISO/NP 17665-1

    16-02-2016
    070864

    Sterilization of health care products -- Moist heat-- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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  • ISO/NP 22413

    14-12-2009
    22413

    Transfer sets for pharmaceutical preparations - Requirements and test methods

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  • ISO/NP 22413

    26-01-2016
    070728

    Transfer sets for pharmaceutical preparations -- Requirements and test methods

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    ISO
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  • IEC/NP 60601-1-8

    29-10-2010
    60601-1-8

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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  • No reference

    26-08-2005
    00102073

    Steam sterilizers - General requirements

    Oprindelse:
    CEN
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    Beskrivelse
    Performance requirements and test methods for moist heat sterilizers intended to process medical devices, laboratory equipment and medical waste.
  • No reference

    27-01-2006
    00163073

    Sanitary appliances - Baths made from impact modified extruded acrylic sheets - Requirements and test methods

    Oprindelse:
    CEN
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    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European standard specifies the requirements for baths for domestic purposes made from impact modified extruded acrylic sheet conforming with EN 13558 with the aim of ensuring that the product, when installed in accordance with the manufacturer’s instructions, will provide satisfactory performance in use.
  • No reference

    27-01-2006
    00216049

    Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for non-porous surfaces in the medical area - Test method and requirements (phase 2, step 2)

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This European Standard applies to products that are used in the medical area for disinfecting surfaces. NOTE – This method corresponds to a phase 2, step 2 test.
  • No reference

    15-02-2007
    00216054

    Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or – in the case of ready to use products – with water. This European Standard is applicable to products for use in the veterinary area – i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. NOTE 1 – The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used. NOTE 2 – This method corresponds to a phase 2 step 2 test.
  • No reference

    15-02-2007
    00216055

    Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or – in the case of ready to use products – with water. This European Standard is applicable to products for use in the veterinary area – i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. NOTE 1 – The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used. NOTE 2 – This method corresponds to a phase 2 step 2 test.
  • No reference

    18-12-2009
    00216069

    Chemical disinfectants and antiseptics - Medical instrument disinfectants - Sporicidal activity - Test method and requirements (phase 2/step 2)

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
  • No reference

    18-12-2009
    00216071

    Chemical disinfectants and antiseptics - Quantitative suspension test for the valuation of sporicidal activity of chemical disinfectants and antiseptics used in the veterinary field - Test method and requirements (phase 2/step 1)

    Oprindelse:
    CEN
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  • No reference

    20-01-2012
    00216081

    Methods of airborne disinfection of surfaces - Determination of bactericidal, fungicidal, yeasticidal and sporicidal activity

    Oprindelse:
    CEN
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    Status
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    Beskrivelse
    The method described herein is designed to determine the disinfectant activity of processes used in hospital, medical, pharmaceutical and cosmetics, veterinary, industrial and food processing areas. The product trialled is designed to be diffused as gaseous molecules or solid or liquid-form dispersants. NOTE Concerning automatic disinfectant processes: the limits to use, especially in terms of ability to diffuse throughout the room (min and max effective volumes), shall be specified and stated in the test report; certain automatic disinfection processes are only suitable for use in large-volume spaces well in excess of 150 m3. Under these conditions, the systems cannot be tested in indoor spaces less than 150 m3 due to the high power of the jet spray; ""additional experimental conditions"" (see 5.5.1.1.f) should therefore be used and the tests should only be performed in test rooms with volumes different to the obligatory conditions.
  • No reference

    20-01-2012
    00216082

    Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants used in food, industrial, domestic, and institutional areas- Test method and requirements (phase 2, step 2)

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for virucidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water and that are used in medical area for non-porous hard surfaces. The field of application of this European Standard applies a type of virus which can be transmitted to the consumer via food in areas where food ready for consumption is prepared, stored, handled and distributed. Such situation may occur in: - catering facilities, kitchens in restaurants and hotels or similar places. Using this European Standard, it is possible to determine the virucidal activity of the undiluted product. As three concentrations have to be tested, in the active to non active range, dilution of the product is required and, therefore, the product shall form a homogeneous stable preparation in hard water. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used. NOTE 2 This method corresponds to a phase 2/step 2 test (see annex X).
  • No reference

    20-01-2012
    00216083

    Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of sporicidal activity against anaerobic spores in the food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 2).

    Oprindelse:
    CEN
    Emner
    Status
    Forslag om nyt arbejdsemne under udarbejdelse
    Beskrivelse
    This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water – or water for ready-to-use products – and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. This European Standard applies at least to the following : a) processing, distribution and retailing of : 1) food of animal origin : _ milk and milk products ; _ meat and meat products ; _ fish, seafood, and related products ; _ eggs and egg products ; _ animal feeds ; _ etc. ; 2) food of vegetable origin : _ beverages ; _ fruits, vegetables and derivatives (including sugar, distillery, etc.) ; _ flour, milling and baking ; _ animal feeds ; _ etc. ; b) institutional and domestic areas : _ catering establishments ; _ public areas ; _ public transports ; _ schools ; _ nurseries ; _ shops ; _ sports rooms ; _ waste containers (bins, etc.) ; _ hotels ; _ dwellings ; _ clinically non sensitive areas of hospitals ; _ offices ; _ etc. ; c) other industrial areas : _ packaging material ; _ biotechnology (yeast, proteins, enzymes, etc.) ; _ pharmaceutical ; _ cosmetics and toiletries ; _ textiles ; _ space industry, computer industry ; _ etc.
  • No reference

    08-12-2014
    00216088

    Chemical disinfectants and antiseptics - Virucidal Hygienic handrub - Test method and requirements (phase 2/step 2)

    Oprindelse:
    CEN
    Emner
    Status
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    Beskrivelse
    This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: – in hospitals, in community medical facilities and in dental institutions; – in clinics of schools, of kindergardens and of nursing homes. and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations. NOTE 2 This method corresponds to a phase 2, step 2 test.

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