Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 243 (Cleanroom technology)
Původce: CEN
K připomínkám do: 24.06.2018
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This part of ISO 14644 gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. The standard provides guidance for the design, construction, commissioning and operation of cleanrooms. It covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications. It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies.

Komise : CEN/TC 79 (Respiratory protective devices)
Původce: CEN
K připomínkám do: 25.06.2018
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This document is applicable to respiratory protective devices except diving apparatus.

NOTE          Definitions for diving apparatus are given in EN 250.

This document defines commonly used terms and definitions and specifies units of measurement to achieve a uniform interpretation and to prevent ambiguous use. It indicates graphical symbols that may be required to be placed on respiratory protective devices (RPD) or parts of RPD or instruction manuals in order to instruct the person(s) using the RPD as to its operation.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 25.06.2018
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This International Standard specifies performance requirements and test methods under prescribed laboratory conditions for the evaluation of pumped samplers used in conjunction with an air sampling pump and of procedures using these samplers for the determination of gases and vapours in workplace atmospheres.

NOTE          For the sampling of semi-volatile compounds which can appear as a mixture of vapours and airborne particles in workplace atmospheres see EN 13936.

This International Standard is applicable to pumped samplers and measuring procedures using these samplers in which sampling and analysis are carried out in separate stages.

This International Standard is not applicable to:

pumped samplers which are used for the direct determination of concentrations, for example, length-of-stain detector tubes;

samplers which rely on sorption into a liquid, and subsequent analysis of the solution (bubblers).

Oblast zaměření: Chirurgické implantáty
Komise : CEN/CLC/JTC 16 (CEN/CENELEC Joint Working Group on Active Implantable Medical Devices)
Původce: CEN
K připomínkám do: 27.06.2018
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This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia.

The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.

This document was designed for tachyarrhythmia pulse generators used with either endocardial or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.

This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).

The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.

Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.

NOTE 1   The device that is commonly referred to as an active implantable medical device might in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2   The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.

NOTE 3   In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

NOTE 4   Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this document.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/CLC/JTC 16 (CEN/CENELEC Joint Working Group on Active Implantable Medical Devices)
Původce: CEN
K připomínkám do: 27.06.2018
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This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.

The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.

This document was designed for Bradyarrhythmia pulse generators used with endocardial or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of  manufacturers incorporating these technologies.

This document is also applicable to some non-implantable parts and accessories of the devices (see NOTE 1).

The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.

Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6.

NOTE 1       The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2       In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 1.07.2018
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This European Standard specifies a test method and the minimum requirements for bactericidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products 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. The following areas are at least included:

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.

EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

NOTE 1       The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2       This method corresponds to a phase 2 step 1 test.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 2.07.2018
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This document specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products 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. The following areas are at least included:

a)     processing, distribution and retailing of:

1)    food of animal origin:

2)    food of vegetable origin:

—    milk and milk products;

—    beverages;

—    meat and meat products;

—    fruits, vegetables and derivatives (including sugar, distillery ...);

—    fish, seafood, and related products;

—    flour, milling and baking;

—    eggs and egg products;

—    animal feeds;

—    animal feeds;

—    etc.

—    etc.

 

b)    institutional and domestic areas:

—    catering establishments;

—    public areas;

—    public transports;

—    schools;

—    nurseries;

—    shops;

—    sports rooms;

—    waste containers (bins ...);

—    hotels;

—    dwellings;

—    clinically non-sensitive areas of hospitals;

—    offices;

—    etc.

c)     other industrial areas:

—    packaging material;

—    biotechnology (yeast, proteins, enzymes, ...);

—    pharmaceutical;

—    cosmetics and toiletries;

—    textiles;

—    space industry, computer industry;

—    etc.

EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

NOTE 1       The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2       This method corresponds to a phase 2 step 1 test.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 9.07.2018
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Modification

 

This document (EN 13697:2015/prA1:2018) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.

This document is submitted to the CEN Enquiry.

Option 1

Data from the latest EN 13697 are still valid with the exception of:

—           Pseudomonas aeruginosa and Candida albicans under clean conditions

or

Option 2

Data from the latest EN 13697 are still valid

(to be discussed during CEN Enquiry).

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 10.07.2018
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This document specifies general requirements for eye and face protectors. These protectors are intended to provide protection for the eyes and faces of persons against common occupational hazards such as impacts from flying particles and fragments, optical radiation, dusts, splashing materials, molten metals, heat, flame, hot solids, harmful gases, vapours and aerosols.

Additional requirements for eye and face protectors used during welding and related techniques and for mesh protectors are given in ISO 16321-2 and ISO 16321-3.

This document applies to all afocal (plano) and prescription lens protectors and components.

This document also applies to those products of eye and face protection used for occupational-type tasks but not performed as part of an occupation, e.g. "do-it-yourself".

This document does not apply to:

—    Protectors specifically intended for protection against sunlight for which  ISO 12312 series applies;

—    protectors for medically prescribed applications (not occupational); e.g. eye protection for severe dry eye, tints prescribed for medical conditions;

—    protectors intended to control exposure of the eyes of patients during diagnosis or treatment (e.g. ISO/DTR 22463);

—    protectors for use during medical or e.g. aesthetic applications, e.g. intense light sources (ILS) for which ISO 12609 series applies;

—    protectors specifically intended for sports for which ISO 18527 series applies;

—    laser protectors for which ISO 19818 applies;

—    face protectors intended for live-working to protect against short-circuit electric arcs for which IEC 62819 applies;

—    protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 10.07.2018
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This document specifies additional material, design, performance and marking requirements for eye and face protectors designed to provide protection for the eyes and faces of persons against occupational hazards during welding and related techniques, such as optical radiation, impacts from flying particles and fragments, and hot solids. The other applicable requirements for welding protectors are given in ISO 16321‑1.

This document also applies to those products of eye and face protection used for occupational-type tasks but not performed as part of an occupation, e.g. "do-it-yourself".

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 10.07.2018
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This document specifies the reference test methods for determining the physical and mechanical properties of protectors.

This document does not apply to any eye and face protection requirements standards for which other test methods are specified.

Other test methods may be used if shown to be equivalent.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 10.07.2018
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This document specifies the reference test methods for determining the spherical, cylindrical, and prismatic refractive properties of unmounted and mounted plano lenses (non-corrective lenses) for eye and face protectors.

This document does not apply to any eye and face protection requirement standards for which other test methods are specified.

Other test methods may be used if shown to be equivalent.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce:
K připomínkám do: 10.07.2018
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This document specifies additional material, design, performance and marking requirements for mesh protectors designed to provide protection for the eyes and faces of persons against mechanical hazards such as impacts from flying particles and fragments.

The other applicable requirements for mesh protectors and the frames/mountings to which they are intended to be fitted are given in ISO 16321‑1.

This document is not applicable to protectors for use against liquid splash (including molten metal), hot solid risks, electrical hazards, infrared and ultraviolet radiation. For protection against these hazards suitable additional or alternative protectors according ISO 16321‑1 will be needed.

This document does not apply to mesh protectors used in sports such as fencing.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 10.07.2018
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This document specifies dimensions and tolerances of the headforms used for the testing of eye and face protectors.

Additional information are given for:

—    Anthropometric measurement methods;

—    Anthropometric data for head and face dimensions;

—    Human test panels.

Komise : CEN/TC 293 (Assistive products for persons with disability)
Původce: CEN
K připomínkám do: 13.07.2018
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This document applies to the safety of APTI, which make claims to redistribute the load of the full body, remain in situ during periods of lying, and to prevent and/or treat pressure injuries.

This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system.

This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.

This document does not apply to lying support surfaces used in combination with incubators.

This document will address the combination of a full body support surface and an adjustable mattress support platform. Safety and performance test methods to ensure protection against injuries to the user are the aspects that this document will cover.

This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2016:

04 33 06 Assistive products for tissue integrity (APTI) when lying down:

—    Mattresses and mattress overlays for pressure injury prevention;

—    Mattress coverings for pressure injury prevention mattresses.

12 31 03 Assistive products for sliding and turning:

Devices for changing position or direction of a person using sliding or turning techniques. Only included are the following products intended to be used in a lying position and remain in situ as part of the lying support surface:

—    Sliding products that glide one way and lock the other way;

—    Sheets and underlays in flexible materials with low friction;

—    Fabric sold by the metre, cut as required for repositioning use;

—    Powered turning product;

This excludes sliding boards.

09 07 06 Positioning pillows, positioning cushions and positioning systems e.g:

—    Leg positioners;

—    Arm positioners;

—    Multipurpose body positioners.

18 12 15 Bedding:

—    Draw sheets

NOTE          Through the use of this document, clinicians and manufacturers should consider the impact of other items (including additional APTI) used in conjunction with an APTI on tissue integrity and safety.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 15.07.2018
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This document applies to all eye protectors intended for eye protection against hazards during the sports of Squash, Racquetball and Squash 57 and sports with similar hazards and no greater risks. It applies to eye protectors that incorporate prescription lenses, but not to eye protectors designed for use over spectacles. It deals with materials, construction, optical properties and testing.

Requirements for the labelling and marking of eye protectors and for information to be supplied by the manufacturer are also specified. Information on the selection and use of eye protectors for Squash, Racquetball and Squash 57 is given in Annex A.

This document does not apply to:

a.      sports eye protectors designed for use over prescription spectacles;

b.     eye protectors for occupational applications;

c.      eye protectors without lenses;

d.     eye protectors for sports where the hazards are unrelated to the hazards in or involve greater risks than Squash, Racquetball and Squash 57.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: Generic
K připomínkám do: 15.07.2018
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This document applies to all afocal (plano power) goggles, intended for eye protection against hazards including ultraviolet and visible solar radiation, rain, snow and wind, during downhill skiing, snowboarding and other similar activities. It deals with materials, construction, optical properties and testing.

Requirements for the labelling and marking of goggles and for information to be supplied by the manufacturer are also specified. Information on the Selection and use of downhill skiing and snowboarding goggles is given in Annex A.

This document does not apply to:

a)     eye protectors for protection when operating or travelling on a motorized vehicle;

b)    eye protectors for protection against artificial optical radiation, such as those used in solaria;

c)     eye protectors for direct observation of the sun;

d)    eye protectors intended for sports with unrelated hazards and risks.

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 204 (Sterilization of medical devices)
Původce: CEN
K připomínkám do: 29.07.2018
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This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

1.2     This document is not applicable to:

a)     sterility testing for routine release of product that has been subjected to a sterilization process,

b)    performing a test for sterility (see 3.12), and

NOTE 1       The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.

c)     culturing of biological indicators or inoculated products.

NOTE 2       Guidance on culturing biological indicators is included in ISO 11138-7[5].

Oblast zaměření: Odpady
Komise : ÚNMZ
Původce: Generic
K připomínkám do: 31.07.2018
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Tato norma platí pro výrobu, zkoušení, dodávání a používání kompostů vyráběných pomocí žížal odlišnou technologií než průmyslové komposty a používaných jako organické hnojivo.

Oblast zaměření: Environmentální management
Komise : CEN/SS S26 (Environmental management)
Původce: CEN
K připomínkám do: 3.08.2018
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This document describes principles, requirements and guidelines for adaptation to climate change. This includes the integration of adaptation within or across organizations, understanding impacts and uncertainties and how these can be used to inform decisions.

This document is applicable to any organization, regardless of size, type and nature e.g. local, regional, international, business units, conglomerates, industrial sectors, natural resource management units.

This document can support the development of sector-, aspect- or element-specific climate change adaptation standards.