Zdraví, životní prostředí a zdravotní zařízení

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 26.09.2020
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This document gives requirements and recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.

NOTE       International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Komise : CEN/TC 293 (Assistive products and accessibility)
Původce: CEN
K připomínkám do: 29.09.2020
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This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg, including:

—    stand-up manual wheelchairs, and

—    manual wheelchairs for showering and/or toileting.

This document does not apply to custom-made manual wheelchairs or manual wheelchairs intended for use in sports.

This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 24.10.2020
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This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.

Examples of such specimens are, but not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, sperm, sputum, urine, tissue samples.

Specimens and types of devices specifically excluded include specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.

NOTE       Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.

This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 160 (Protection against falls from height including working belts)
Původce: CEN
K připomínkám do: 26.10.2020
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This document applies to rope adjustment devices intended for use in rope access systems. It specifies the requirements, test methods, marking and manufacturer’s instructions and information.

Komise : CEN/TC 293 (Assistive products and accessibility)
Původce: CEN
K připomínkám do: 3.11.2020
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This document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not greater than 300 kg, including:

—    electrically powered scooters with three or more wheels,

—    manual wheelchairs with an add-on drive system,

—    handrim-activated power-assisted wheelchairs,

—    electrically powered stand-up wheelchairs,

—    balancing wheelchairs,

—    wheelchairs with a pivot drive wheel unit, and

—    assistant-guided wheelchairs.

This document does not apply to custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.

This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 164 (Water supply)
Původce: CEN
K připomínkám do: 3.11.2020
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This document describes a test method for laboratory evaluation of possible adverse effects of water treatment membrane elements and modules on drinking water quality.

In principle it is applicable to microfiltration, ultrafiltration, nanofiltration, reverse osmosis and electrodialysis modules for use in the treatment of public water supplies and of water inside buildings.

NOTE          Such devices can vary considerably in design and operation and hence some modification of the procedures can be required.

Evaluation of the efficiency of the membrane filter in removing contaminants from the treated water is not included.