Hlavní oblasti

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Původce: CEN
K připomínkám do: 28.11.2020
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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.

Oblast zaměření: Kovové koroze
Komise : CEN/TC 262 (Metallic and other inorganic coatings, including for corrosion protection and corrosion testing of metals and alloys)
Původce: CEN
K připomínkám do: 29.11.2020
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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.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 30.11.2020
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Replacement:

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.219, hereafter also referred to as ME equipment, in combination with its accessories:

—    intended for use with patients who can breathe spontaneously; and

—    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.

EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit 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.

Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.

NOTE 1       In the home healthcare environment, the supply mains is often not reliable.

Respiratory 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 respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.

EXAMPLE 2         Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE 2       Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.

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[15];

—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[16];

—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[19][1];

—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[18];

—    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[19];

—    ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[20];

—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16];

—    continuous positive airway pressure (CPAP) ME equipment;

—    high-frequency jet ventilators (HFJVs)[30], which are given in ISO 80601‑2‑87[20];

—    gas mixers for medical use, which are given in ISO 11195[11];

—    high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[20]; and

—    cuirass or “iron-lung” ventilation equipment.

NOTE 3       Respiratory 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 document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents.

 

[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Oblast zaměření: Optika
Komise : CEN/TC 170 (Ophthalmic optics)
Původce: CEN
K připomínkám do: 30.11.2020
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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.

Oblast zaměření: Letectví a kosmonautika
Komise : ASD-STAN (Aerospace)
Původce: CEN
K připomínkám do: 30.11.2020
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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.

Oblast zaměření: Tepelná čerpadla
Komise : CEN/TC 113 (Heat pumps and air conditioning units)
Původce: CEN
K připomínkám do: 30.11.2020
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This document 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 exchange-to-water(brine) heat pumps (DX-to-water(brine)) as defined in EN 15879‑1.

This document also covers hybrid units as defined in this standard.

This document 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 can be based on calculated or measured values.

In case of measured values, this document 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 power input 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 “heating” is used to refer to space heating.

Oblast zaměření: Vláknová optika
Komise : IEC/SC 86A (Fibres and cables)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This test is intended to evaluate the impact of a lightning strike on an OPGW, OPPC or OPAC.

Oblast zaměření: Vláknová optika
Komise : IEC/SC 86A (Fibres and cables)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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The short-circuit test is intended to assess the performance of the OPGW (optical ground wire) or OPPC (optical phase conductor) under typical short-circuit, or the impact on the performance of OPAC (optical attached cable) under short-circuit current on the messenger wire.

Oblast zaměření: Vláknová optika
Komise : IEC/SC 86A (Fibres and cables)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This part of IEC 60794 applies to optical fibre cables for use with telecommunication equipment and devices employing similar techniques, as well as hybrid telecommunication cables having a combination of both optical fibres and electrical conductors.

The object of this standard is to define test procedures to be used in establishing uniform requirements for the material compatibility performance of cables, cable components, and cable subassemblies.

Compatibility of materials within a cable has the potential to involve a range of material pairs.  However, experience has shown that the most pertinent evaluations are of the cable filling and flooding materials interactions with other materials in the cable.

Throughout the standard the wording “optical cable” may also include optical fibre units, microduct fibre units, etc.

See IEC 60794-1-2 for general requirements and definitions and reference guide to test methods of all types.

Oblast zaměření: Navigační přístroje
Komise : IEC/TC 80 (Maritime navigation and radiocommunication equipment and systems)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This part of the standard specifies an S-100 compliant product specification for route plan intended for exchange of information. It specifies the content, structure, and metadata needed for creating fully S-100 compliant route plan information and its portrayal within an S-100-based application. The IHO manages all numbers for S-100 compliant product specifications and has assigned S-421 for this route plan IEC standard.

This document specifies only a data format for the route plan exchange. This document does not specify a data format of vessel monitoring and logging information. This information can be provided by other mechanisms or be specified in other standards.

The format of the route plan exchange includes some limited vessel static information. When more static information is required, it can be obtained by other methods such as AIS.

Komise : IEC/SC 62D (Electromedical equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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Replacement:

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.219, hereafter also referred to as ME equipment, in combination with its accessories:

—    intended for use with patients who can breathe spontaneously; and

—    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.

EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit 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.

Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.

NOTE 1       In the home healthcare environment, the supply mains is often not reliable.

Respiratory 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 respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.

EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE 2       Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.

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[15];

—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[16];

—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[19][1];

—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[18];

—    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[19];

—    ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[20];

—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16];

—    continuous positive airway pressure (CPAP) ME equipment;

—    high-frequency jet ventilators (HFJVs)[30], which are given in ISO 80601‑2‑87[20];

—    gas mixers for medical use, which are given in ISO 11195[11];

—    high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[20]; and

—    cuirass or “iron-lung” ventilation equipment.

NOTE 3       Respiratory 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 document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents.

 

[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Oblast zaměření: Dálkově řízené systémy
Komise : IEC/TC 57 (Power systems management and associated information exchange)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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The IEC 61970-401 document describes how the IEC 61970-450 to -499, IEC TS 61970-600 and IEC 61970-600 profile standards as well as any other CIM based profile specifications are structured and created. Profile documents describe a subset of the canonical CIM dedicated to a specific data exchange, the canonical CIM is described in the IEC 61970-300 series documents as well as the IEC 61968-11.

Rules for creation of canonical CIM is outside the scope of this document.

The IEC 61970-401 document specifies the structure of a profile specification and the rules for creating the subsets from the canonical CIM. The guiding principle for the profiling method is that the information described by a profile is a true subset of the canonical CIM and retain class, role and attribute names from the canonical CIM. The data types in CIM are described by classes stereotyped Primitive or CIMDatatype that is a composition of three attributes value, unit and multiplier. The main objective being that different datasets (see section 3) exchanged using different profiles based on canonical CIM solely rely on the definitions and basic principles of the canonical CIM which is a key to make interoperability efforts feasible. This also enables different profiles to relate data between them by using the canonical CIM as a hub and supports a reader of a data set or a message to easily find descriptions of elements in both the profile and the canonical CIM. The support for relating data in different data sets or messages described by different profiles is required when data is divided across different data sets governed by different profiles. Such use cases are defined for network models where the network description is separated from the operational conditions of the network (seen as an input) and the results.

There are several languages that can describe profiles, e.g. UML (serialized as XMI), RDFS, Ecore or OWL. UML includes a graphical language that is implemented by UML editors. OWL does not have a graphical language, but several editors exist that support the display and editing of OWL data. The language in which a profile is described is outside the scope of this specification as well as how profiles are presented and edited in user interfaces. Relevant specifications are referenced in section 2.

A profile in UML is described by classes, attributes, associations and roles, the common way to describe information in UML. The UML language also include the concept of stereotypes and tagged values that enables custom extensions of the UML language. Hence profiling with UML means copying and updating classes, attributes, associations and stereotypes from the canonical CIM. A profile in OWL is described by classes and properties. There are two types of OWL properties matching with UML attributes and UML roles. Profiling in OWL means creating OWL classes and properties by selecting UML classes, attributes, and roles from canonical CIM the same way as it is done for profiling with UML. This specification standardizes the operations used to create the profile elements from the canonical CIM. As canonical CIM is described in UML the operations are described in the terms of UML classes, attributes and roles. There is a mapping between UML and OWL so either language can be used to describe the created profiles.

This specification support profiles describing data exchanged with CIMXML files according to IEC 61970-552. But other formats are also supported if the exchanged data comply with profiles created according to this document.

Tools that process data described by profiles created according to this document will need a machine-readable version of the profiles, also called syntactical profile. IEC 61970-501 is an RDFS based serialization intended for this. Hence profiling tools shall support the generation of profiles in the IEC 61970-501 serialisation format. Any tool, regardless if it is based on UML or OWL, will have to serialize profiles into a syntactical profile that can be saved to a file for persistency. As IEC 61970-501 does not contain all information needed by profiling tools it cannot be used to serialize profiles for persistency nor support profiling tool interoperability. Tool interoperability and serialisation formats are outside the scope of this specification. Figure 1 below gives an overview of the IEC 61970 standards in the context of profiling.

Figure 1 Relations between standards and profiling

The canonical CIM is showed at the top in Figure 1, e.g. IEC 61970-301. Based on the canonical CIM and a context for the usage a contextual profile is created. This document specifies the rules for creation of contextual profiles. A serialisation of the contextual profile is a syntactic profile. The serialisation format for contextual profiles in IEC 61970 is described in IEC 61970-501 which is not in the scope for this document. IEC 61970-501 is not the only syntactical profile, a UML based tool may save the profile in the XMI format, a tool based on Eclipse Modelling Framework (EMF) may save a profile in Ecore and an OWL based tool may use RDF/XM. All these syntactical profiles describe the same contextual profile but in different ways. To enable interoperability between syntactical profiles on different formats it is important that the semantics from the contextual profile is the same.

Datasets on CIMXML format are serialized according to IEC 61970-552 and the data in a CIMXML file is described by a profile. The contextual and syntactic profile are the same with the difference that the syntactic profile is machine readable and can be used in validation of CIMXML files. IEC 61970-552 is not in scope of this document.

Oblast zaměření: Hliníkové elektrické vodiče
Komise : IEC/SC 46F (RF and microwave passive components)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This specification defines general requirements and test methods for waveguide to coaxial adapters. It includes terms and definitions, design and construction, ratings and characteristics, climatic categories, IEC type designation, requirements and test methods, quality assessment, marking, and etc.

It provides the basis for establishing the sectional specifications for various waveguide to coaxial adapters.

This part applies to waveguide to coaxial adapters (short name adapter).

For the purpose of this specification, according to ends, adapters are classified as the following:

Class Ⅰ:Waveguide to coaxial connector adapter, waveguide at one end, and coaxial connector at the other end;

Class Ⅱ:Waveguide to coaxial cable adapter, waveguide at one end,and coaxial cable at the other end;

Class Ⅲ:Waveguide to coaxial cabled connector adapter, waveguide at one end,and coaxial cabled connector at the other end.

According to whether the inner conductor probe of coaxial end is connected with the inner wall of waveguide cavity or not, adapters are classified as the following:

Connected adapter: Inner conductor probe of coaxial end is connected with inner wall of waveguide cavity;

Disconnected adapter: inner conductor probe of coaxial end is disconnected with inner wall of waveguide cavity.

Oblast zaměření: Kondenzátory a rezistory
Komise : IEC/TC 40 (Capacitors and resistors for electronic equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This standard applies to fixed inductors designed for electromagnetic interference suppression, which will be connected to an AC mains or other supply with a nominal voltage not exceeding 1000 V AC r.m.s or 1500 V DC with a nominal frequency not exceeding 400 Hz.

This International Standard is restricted to fixed inductors for which safety tests are appropriate. This implies that inductors specified according to this specification will either be connected to mains supplies, when compliance with the mandatory tests of Annex A is necessary, or used in other circuit positions where the equipment specification prescribes that some or all of these safety tests are required.

The object of this standard is to prescribe standard requirements for safety tests, preferred ratings and characteristics, to select from IEC 60938-1 the appropriate methods of test and to give general performance requirements for suppression inductors. Test severities and performance requirements prescribed in detail specifications referring to this sectional specification shall be of equal or higher performance level. In addition, the minimum requirements for safety tests specified herein always apply.

Oblast zaměření: Primární baterie
Komise : IEC/TC 35 (Primary cells and batteries)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 1.12.2020
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This part of IEC 60086 specifies tests and requirements for primary batteries with aqueous electrolyte to ensure their safe operation under intended use and reasonably foreseeable misuse.

Oblast zaměření: Měřidla
Komise : CEN/TC 318 (Hydrometry)
Původce: CEN
K připomínkám do: 5.12.2020
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This International Standard gives terms, definitions and symbols used in standards in the field of hydrometry.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 5.12.2020
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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.

Komise : CEN/TC 89 (Thermal performance of buildings and building components)
Původce: CEN
K připomínkám do: 7.12.2020
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This International Standard specifies two alternative methods for determining hygroscopic sorption properties of porous building materials and products:

a)    using desiccators and weighing cups (desiccator method);

b)    using a climatic chamber (climatic chamber method).

The desiccator method is the reference method.

This International Standard does not specify the method for sampling.

The methods specified in this International Standard can be used to determine the moisture content of a sample in equilibrium with air at a specific temperature and humidity.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 7.12.2020
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This document 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 document.

This document 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, dental institutions and medical laboratories for analyses and research,

—    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 and veterinary laboratories for analyses and research. 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, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.

This document is also applicable to active substances and products under development for which no area of application has yet been specified.

This document 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 document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

Oblast zaměření: Obaly
Komise : CEN/TC 261 (Packaging)
Původce: CEN
K připomínkám do: 7.12.2020
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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.