Zdraví, životní prostředí a zdravotní zařízení

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 2.12.2019
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ISO 18190:2016 Clause 1 is replaced by the following

This document specifies essential performance and safety requirements for cuff pressure indicator devices used to indicate the intracuff pressure of airway devices. Such devices are primarily designed to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This standard is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device may also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 3.12.2019
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This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

EXAMPLES          Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.

NOTE 1       The Luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.

This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are specified in other documents:

—    haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);

—    haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);

—    infusion system closure piercing connectors (ISO 8536‑4).

NOTE 2       Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

NOTE 3       ISO 80369‑1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369‑1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this part of ISO 80369.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 3.12.2019
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This document specifies procedures to determine the impact sound insulation using sound pressure measurements with an impact source operating on a floor or stairs in a building. These procedures are intended for room volumes in the range from 10 m3 to 250 m3 in the frequency range from 50 Hz to 5 000 Hz. The test results can be used to quantify, assess and compare the impact sound insulation in unfurnished or furnished rooms where the sound field can approximate to a diffuse field.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 7.12.2019
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ISO 10848 (all parts) specifies laboratory and field measurement methods to characterize the flanking transmission of one or several building components.

This part of ISO 10848 specifies measurement methods to be performed in the laboratory to characterize the acoustic radiation of a building element when it is directly excited by an airborne or structure-borne source. It is applicable to single-leaf and double-leaf elements (see ISO 12354-1:2017 Annex F, F2). The measured quantity can be used as input data for prediction methods, such as ISO 12354-1 and ISO 12354-2, to compare products, or to express a requirement.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 85 (Eye protective equipment)
Původce: CEN
K připomínkám do: 16.12.2019
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Amendment

Oblast zaměření: Kvalita půdy
Komise : CEN/TC 444 (Test methods for environmental characterization of solid matrices)
Původce: CEN
K připomínkám do: 20.12.2019
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This document specifies two methods for digestion of soil, treated biowaste, sludge and waste by the use of aqua regia as digestion solution.

Digestion with aqua regia will not necessarily accomplish total decomposition of the sample. The extracted analyte concentrations may not necessarily reflect the total content in the sample but represent the aqua regia soluble metals under the condition of this test procedure. It is generally agreed that for environmental analysis purposes, the results are fit for the intended purpose to protect the environment.

This document is applicable for the following elements:

Aluminium (Al), antimony (Sb), arsenic (As), barium (Ba), beryllium (Be), boron (B), cadmium (Cd), calcium (Ca), chromium (Cr), cobalt (Co), copper (Cu), iron (Fe), lead (Pb), magnesium (Mg), manganese (Mn), mercury (Hg), molybdenum (Mo), nickel (Ni), phosphorus (P), potassium (K), selenium (Se), silver (Ag), sodium (Na), strontium (Sr), sulfur (S), tellurium (Te), thallium (Tl), tin (Sn), titanium (Ti), , vanadium (V), and zinc (Zn),.

This document can also be applied for the digestion of other elements, provided the user has verified the applicability.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 243 (Cleanroom technology)
Původce: CEN
K připomínkám do: 21.12.2019
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This part of the ISO 14644 standards gives guidance on the interpretation and application of the results of the measurement of Particle Deposition Rate (PDR) on one, or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some guidance on how to influence the PDR and reduce the risk of particle contamination on vulnerable surfaces.

This standard gives information on how a cleanroom user can use the PDR measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the PDR.

Note to entry: An alternative to the PDR is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The POR can be used in an analogous way to the PDR and the required POR for a specified surface can be calculated and the risk from deposited particles reduced.

This standard does not:

•      provide a method to classify a cleanroom with respect to PDR or POR,

•      directly consider the deposition of microbe-carrying particles (MCPs), although MCPs can be treated as particles,

•      give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 23.12.2019
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Amendment

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 23.12.2019
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Amendment

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 426 (Domestic appliances used for water treatment not connected to water supply)
Původce: CEN
K připomínkám do: 30.12.2019
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Amendment