Pregled nacrta

Odbor: HZN/TO 215 (Zdravstvena informatika)
Ustanova izvornika:
Rok za komentiranje: 2020-11-25
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This Standard:

—    Specifies clinical information models (CIMs) as health and care concepts that can be used to define and to structure information for various purposes in health care, also enabling information reuse.

—    Describes requirements for CIMs content, structure and context and specification of their data elements, data element relationships, meta-data and versioning, and provides guidance and examples.

—    Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems integration in the health domain, and secondary use of data including for public health reporting.

—    Defines a Quality Management System (QMS) for a systematic and effective governance, quality management, and measurement of CIMs through their lifecycle of development, testing, distribution, application and maintenance.

—    Provides principles to be followed in the transformation and application of clinical information models through the wide variation of health information technology.

This Standard excludes:

—    Normative specification of the content or application of any particular clinical information model or clinical information modelling methodology. However, informative examples are presented.

—    Specific applications of clinical information models such as for dynamic modelling of workflow.

—    Specifications for modelling entire domains or aggregates of many CIMs such as complete assessment documents or discharge summaries. It will not specify CIMs compositions.

—    Specification of how to involve specific clinicians, how to carry out governance including information governance, or how to ensure patient safety.

Odbor: HZN/TO 555 (Medicinski proizvodi)
Ustanova izvornika:
Rok za komentiranje: 2020-11-28
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1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT.
1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.

 

Odbor: HZN/TO 8 (Brodogradnja)
Ustanova izvornika:
Rok za komentiranje: 2020-11-28
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This document establishes requirements for design, construction, installation and test of petrol and diesel fuel tanks, for internal combustion engines, that are intended to be permanently installed in small craft.

For installation requirements, ISO 10088:2013 applies.

Odbor: HZN/TO 504 (Korozija i zaštita metala i legura)
Ustanova izvornika:
Rok za komentiranje: 2020-11-29
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This part of ISO 4524 specifies four electrographic tests for assessing the porosity of electrodeposited gold and gold alloy coatings for engineering, and decorative and protective purposes.

Odbor: HZN/TO 172 (Optika i optički instrumenti)
Ustanova izvornika:
Rok za komentiranje: 2020-11-30
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This document applies to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids. This document contains requirements and test methods for optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision devices.

Implanted low vision devices are excluded.

Odbor: HZN/TO 121 (Anestetička i respiracijska oprema)
Ustanova izvornika:
Rok za komentiranje: 2020-11-30
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This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
- intended for use in professional healthcare facilities;
- intended for use by a lay operator or a healthcare professional operator;
- intended for use with patients who can breathe spontaneously;
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and
EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
- not intended for patients who are dependent on artificial ventilation for their life support.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Ventilatory high-flow therapy equipment is typically composed of four parts:
1) gas sources,
- air, and
- if needed, oxygen;
NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air.
2) humidifier;
NOTE 3 When dry gas is utilized, a humidifier is typically needed.
3) breathing tube;
4) a patient interface, which is used to deliver gas to the patient; and
5) a flow controller, which is used to select and deliver the desired flow.
NOTE 4 The flow controller can be at a fixed rate.
NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates).
These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy.
Ventilatory high-flow therapy equipment can be transit-operable.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601 2 12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79;
- ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80;
- sleep apnoea therapy ME equipment, which are given in ISO 80601 2 70;
- continuous positive airway pressure (CPAP) ME equipment;
- high-frequency jet ventilators (HFJVs);
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and
- cuirass or "iron-lung" ventilation equipment.
NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes.
This docum.....

 

Odbor: HZN/TU T1 (Prijevoz, rukovanje materijalima i pakiranje 1)
Ustanova izvornika:
Rok za komentiranje: 2020-11-30
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This document defines the requirements for hexavalent chromium free anodizing of aluminium and aluminium alloys for corrosion protection, bonding and painting.

Hard anodizing and plasma electrolytic anodizing (micro-arc oxidation) are not covered by this document.

The purpose of this document is to give design, quality and manufacturing requirements. It does not give complete in-house process instructions; these are given in the processors detailed process instructions.

Odbor: HZN/TO 86 (Uređaji za hlađenje, klimatizaciju i dizalice topline)
Ustanova izvornika:
Rok za komentiranje: 2020-11-30
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This European Standard covers air conditioners, heat pumps and liquid chilling packages, including comfort and process chillers. It applies to factory made units defined in EN 14511-1, except single duct, double duct, control cabinet and close control units. It also covers direct expansion-to-water(brine) heat pumps (DX-to-water) as defined in EN 15879-1.
This European Standard also covers hybrid heat pumps as defined in this standard.
This European Standard gives the temperatures and part load conditions and the calculation methods for the determination of seasonal energy efficiency SEER and SEERon, seasonal space cooling energy efficiency ηs,c seasonal coefficient of performance SCOP, SCOPon and SCOPnet, and seasonal space heating energy efficiency ηs,h and seasonal energy performance ratio SEPR.
Such calculation methods may be based on calculated or measured values.
In case of measured values, this European Standard covers the test methods for determination of capacities, EER and COP values during active mode at part load conditions. It also covers test methods for electric power consumption during thermostat-off mode, standby mode, off-mode and crankcase heater mode.
NOTE 1 The word "unit" is used instead of the full terms of the products.
NOTE 2 The word "cooling" is used to refer to both space cooling and process cooling.
NOTE 3 The word "heating" is used to refer to space heating.

Odbor: HZN/TU S1 (Zdravlje, okoliš i medicinska oprema 1)
Ustanova izvornika:
Rok za komentiranje: 2020-12-05
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This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants.

NOTE      The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

Odbor: HZN/TO 513 (Mjerne jedinice i mjerila)
Ustanova izvornika:
Rok za komentiranje: 2020-12-05
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This International Standard gives terms, definitions and symbols used in standards in the field of hydrometry.

Odbor: HZN/TO 159 (Ergonomija)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This document can be used to compare the performance of different ensembles as part of any PPE selection process.
This document does not replace the product standards for the certification of individual items of PPE. It specifies the testing of individual items of PPE as an ensemble, so that the interaction between the individual items of PPE can be evaluated and any adverse interactions between the individual items of PPE can be identified.
It specifies requirements for testing by either assessing the performance of a PPE ensemble against a benchmark condition (i.e. benchmark testing) or assessing the performance of two or more PPE ensembles against each other (i.e. comparative testing).
The standard incorporates laboratory as well as field based testing. It can also be used to assess the performance regarding the ergonomics of an ensemble that incorporates an item of PPE that has never before been incorporated into an ensemble.

Odbor: HZN/TO 92 (Zaštita od požara)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This European Standard covers hinged or pivoted doorsets with timber based leaves, timber framed glazed doors and openable timber framed windows. It prescribes the methodology for extending the application of test results obtained from fire resistance test(s) conducted in accordance with EN 1634-1.
Subject to the completion of the appropriate test or tests, the extended application may cover all or some of the following examples:
- integrity (E), integrity/radiation (EW) or integrity/insulation (EI1 or EI2) classification;
- glazed elements including vision panels and framed glazed doorsets, 
- louvres and/or vents;
- side, transom or overpanels;
- items of building hardware;
- decorative finishes;
- intumescent, smoke, draught or acoustic seals;
 alternative supporting construction(s).
The effect on the Classification ‘C’ for the doorsets following an extended application process is not addressed in this European Standard.
Odbor: HZN/TO 21 (Protupožarna i vatrogasna oprema)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This document specifies product characteristics and describes test methods for flexible and rigid connectors intended to be used in gas extinguishing systems (i.e. CO2, Inert Gas or Halocarbon gas) installed in buildings as a part of a complete operating system.
This document is applicable to the following connectors:
- Type 1 and Type 5: used between container valves and the manifold
- Type 3: used in pneumatic pilot lines
- Type 2 and Type 4: used in distribution pipework of fire extinguishing installations downstream of the manifold/selector valve.
Odbor: HZN/TO 539 (Kemijski dezinficijensi i antiseptici)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard.
This European Standard also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
It is intended to:
a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;
b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;
c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.
In the area of human medicine (Working Group 1, i. e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care
— in hospitals, in community medical facilities and dental institutions,
— in clinics of schools, of kindergartens and of nursing homes,
— and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.
In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, pharmaceutical, cosmetic etc. industries.
This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified.
This standard will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards should be used, even if they are not yet mentioned in EN 14885. 
This European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.
Odbor: HZN/TO 515 (Žičare, uspinjače i vučnice)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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- The scope of the standard to be amended is:
This European Standard specifies the safety requirements applicable to carriers for cableway installations designed to carry persons. This part of EN 12929 specifies the safety requirements for the general requirements for cableway installations designed to carry persons. These requirements are applied to the various types of installations and their environment.
This document defines general technical characteristics and prescribes design principles and general safety requirements.
It does not deal with details of operation and maintenance, nor with calculations and detailed requirements for the manufacture of components.
This Part 1 does not deal with special regulations applicable to bi-cable reversible aerial ropeways without carrier truck brakes, which are the subject of Part 2.
It includes requirements relating to the prevention of accidents and the protection of workers.
It does not apply to cableway installations for transportation of goods or to lifts.
Clause 11 describes the minimum requirements to be normatively satisfied for passageways and work areas. National regulations of a building or federal/state nature or which serve to protect particular groups of people remain unaffected.
It may not always be possible for all types of cableway installation to transport all particular groups of people (e.g. persons with restricted mobility). The objective should be, however, for a cableway installation to enable the transportation of the largest possible passenger population.

- The scope of the proposed amendment A1 on this standard is to modify article 10.2 on braking system in order to be in line with the text of the regulation 2016/424/

Odbor: HZN/TO 515 (Žičare, uspinjače i vučnice)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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- The scope of the standard to be amended is:
This European  Standard  specifies  safety  requirements  for  the  mechanical  and  electrical  devices  of  the  drive  
system  and  other  mechanical  devices  for  cableway  installations  designed  to  carry  persons.  This  standard  is  
applicable to the various types of installations and takes into account their environment.
This European  Standard applies  to  the  design,  manufacture,  installation, maintenance  and  operation  of  the  
mechanical and electrical devices of the drive system and other mechanical devices for cableway installations 
designed to carry persons.
It  includes  requirements  concerning  the  prevention  of  accidents  and  the  protection  of  workers  without  
prejudice to the application of national regulations.
National  regulations  regarding building  or  construction or  that  are  designed  to  protect  particular  groups  of  people, remain unaffected. It does not apply to installations for the transportation of goods, or to lifts. 
Clauses 6 to 11 apply to the mechanical and electrical devices of the drive system.
Clauses 12 to 20 apply to other mechanical devices.

- The scope of the proposed amendment A1 on this standard is to modify Article 9.10 on Safety break in order to be in line with the text of the regulation 424/2016

Odbor: HZN/TO 508 (Ambalaža i pakiranje)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This document specifies dimensions of neck finishes for aerosol and spray glass containers, in order to guarantee tight sealing of valves or pumps with ferrules defined by EN 14849.
It applies to glass containers with a nominal diameter of the neck finish around 11 mm, 13 mm, 15 mm, 17 mm, 18 mm and 20 mm for both moulded and tubular glass neck finishes.
NOTE These neck finishes are commonly called FEA 11, 13, 15, 17, 18 and 20.
Odbor: HZN/TO 534 (Spremnici za teret)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This document specifies the quality characteristics of hydrogen fuel dispensed at hydrogen refuelling stations for use in proton exchange membrane (PEM) fuel cell road vehicle systems, and the corresponding quality assurance considerations for ensuring uniformity of the hydrogen fuel.

Odbor: HZN/TO 37 (Terminologija)
Ustanova izvornika:
Rok za komentiranje: 2020-12-07
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This document specifies requirements for typical conference systems, the parts they are composed of, the auxiliary devices necessary for their use (such as microphones, headphones, and sound reinforcement equipment) and the environment in which they are used. These requirements ensure interoperability and optimum performance under conditions of normal operation.
It is applicable to both wired and wireless systems.
The environment and areas where events are held are described in Annex A.
This document facilitates the determination of the quality of conference systems, the comparison of different systems and the assessment of their proper use by listing their characteristics. This document contains the technical backbone of ISO 20108 and ISO 20109.

Odbor: HZN/TO 506 (Materijali, oprema i konstrukcije za naftnu industriju, prirodni plin i geotermalnu vodu)
Ustanova izvornika:
Rok za komentiranje: 2020-12-11
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This document defines requirements for the fabrication, welding, examination and testing of new, metallic piping systems up to 69 000 kPa (ga) maximum, within temperature range limits for the materials meeting the requirements of ASME B31.3, on fixed and floating offshore production facilities and onshore production, processing and liquefaction plants. 
This document is applicable to all pressure retaining components and any non-pressure retaining component, such as a pipe support, welded directly to a pressure retaining component.
This document is not applicable to:
- marine-related piping systems, e.g. ballasting piping systems, systems covered by classification societies;
- non-metallic piping systems.