Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 23.02.2020
Zobraz více Zobraz méně
 

This part of ISO 717:

a)    defines single-number quantities for impact sound insulation in buildings and of floors;

b)    gives rules for determining these quantities from the results of measurements carried out in one-third-octave bands in accordance with ISO 10140-3 and ISO 16283-2, and in octave bands in accordance with that option in ISO 16283-2 for field measurements only;

c)    defines single-number quantities for the impact sound reduction of floor coverings and floating floors calculated from the results of measurements carried out in accordance with ISO 10140-3;

d)    specifies a procedure for evaluating the weighted reduction in impact sound pressure level by floor coverings on lightweight floors.

The single-number quantities in accordance with this part of ISO 717 are intended for rating impact sound insulation and for simplifying the formulation of acoustical requirements in building codes. An additional single-number evaluation in steps of 0,1 dB is indicated for the expression of uncertainty (except for spectrum adaptation terms).The required numerical values of the single-number quantities are specified according to varying needs.

The rating of results from measurements carried out over an enlarged frequency range is described in Annex A.

A method for obtaining single-number quantities for bare heavy floors according to their performance in combination with floor coverings is described in Annex B.

Examples of the calculation of a single-number quantity is given in Annex C.

A method for rating heavy/soft impact sound insulation performance of building and building materials by A-weighted maximum impact sound pressure level is given in Annex D.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 27.02.2020
Zobraz více Zobraz méně
 

This document specifies general requirements for medical suction equipment that are common to all parts of the 10079 series.

The ISO 10079 series does not apply to the following:

a)    end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;

b)    syringes;

c)    dental suction equipment;

d)    anaesthetic gas scavenging systems;

e)    laboratory suction;

f)     autotransfusion systems;

g)    mucus extractors including neonatal mucus extractors;

h)    suction equipment where the collection container is downstream of the vacuum pump;

i)     ventouse (obstetric) equipment;

j)     suction equipment marked for endoscopic use only

k)    plume evacuation systems.

Komise : CEN/TC 293 (Assistive products and accessibility)
Původce: CEN
K připomínkám do: 29.02.2020
Zobraz více Zobraz méně
 

This document provides a classification and defines terms for absorbent incontinence products.

The document builds on ISO 9999, Assistive products for persons with disability — Classification and terminology, sub-class 09 30 – Absorbing products to contain urine and faeces. This document also provides preferred terms, additional terms and example pictures.

Oblast zaměření: Kvalita půdy
Komise : CEN/TC 444 (Test methods for environmental characterization of solid matrices)
Původce: CEN
K připomínkám do: 1.03.2020
Zobraz více Zobraz méně
 

This document specifies an instrumental method for the routine determination of pH within the range pH 2 to pH 12 using a glass electrode in a 1:5 (volume fraction) suspension of soil, sludge and treated biowaste in water (pH in H2O), in 1 mol/l potassium chloride solution (pH in KCl) or in 0,01 mol/l calcium chloride solution (pH in CaCl2).

This document is applicable to all types of air-dried soil and treated biowaste samples.

NOTE       For example pretreated in accordance with ISO 11464 or EN 16179 or EN 15002.

Oblast zaměření: Environmentální management
Komise : CEN/SS S26 (Environmental management)
Původce: CEN
K připomínkám do: 1.03.2020
Zobraz více Zobraz méně
 

1.1. This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.

1.2. Bodies operating according to this document can provide validation/verification as first party, second party as well as third party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.

1.3. This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.

1.4. This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.

1.5. This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.

NOTE       This document contains generic requirements and is neutral with regard to the validation/ verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.

 

1.6  This document specifies principles and requirements for bodies performing validation and verification of environmental information.

1.7  Any programme requirements related to bodies are additional to the requirements of this document.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 2.03.2020
Zobraz více Zobraz méně
 

This International Standard specifies an alternating airflow method for the determination of the airflow resistance [1], [2] of porous materials for acoustical applications.

Determination of the airflow resistance based on static flow is described in ISO 9053‑1.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 9.03.2020
Zobraz více Zobraz méně
 

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.

Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors, and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.

NOTE       Particular requirements for specific types of portable dental equipment for use in non- permanent healthcare environments will be specified in subsequent parts of this document.

This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that may be installed in a dental mobile medical facility (e.g., vehicular or containerized mobile dental clinic) are not considered in this document.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 9.03.2020
Zobraz více Zobraz méně
 

This document specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.

NOTE       In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 10.03.2020
Zobraz více Zobraz méně
 

Replacement:

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:

intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE 1    For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.

NOTE 2    For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 3    A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as an ventilator intended for the emergency medical services environment.

intended to be operated by a healthcare professional operator;

intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and

capable of providing more than 150 inflations/min.

There are three principal designations of HFV:

high frequency percussive ventilation (HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min); 

high frequency jet ventilation (HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min); and

high frequency oscillatory ventilation (HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase). 

Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.

* A high-frequency ventilator is not considered to utilize physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.

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 7.2.13 and 8.4.1 of IEC 60601-1:2005.

NOTE 4    Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.

This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.

This document does not specify the requirements for:

< >

< > or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [3] [1];

< > or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84, the future replacement for ISO 10651-3 [4];

< > or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72 [5];

< > or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7], the replacements for ISO 10651-6 [8];

sleep apnoea breathing therapy ME equipment, which are given in ISO 80601-2-70 [9];

< > positive airway pressure (CPAP) ME equipment;

oxygen therapy constant flow ME equipment; and

cuirass or “iron-lung” ventilation equipment.

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

 

[1]   Figures in square brackets refer to the Bibliography.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 16.03.2020
Zobraz více Zobraz méně
 

This document specifies general performance requirements for procedures for the determination of the concentration of chemical agents in workplace atmospheres as required by the Chemical Agents Directive 98/24/EC [5]. These requirements apply to all steps of measuring procedures regardless of the physical form of the chemical agent (gas, vapour, airborne particles), measuring procedures with separate sampling and analytical methods, and direct-reading devices.

This document specifies requirements that are fulfilled by measuring procedures when tested under prescribed laboratory conditions due to a wide range of environmental conditions encountered in practice.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 159 (Hearing protectors)
Původce: CEN
K připomínkám do: 16.03.2020
Zobraz více Zobraz méně
 

This document gives guidance on the appropriate selection of fit testing methods and measurement, and provides practical guidance on fit testing methods, their uses and limitations.

This document does not specify the technical requirements for manufacturing fit testing equipment.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 21.03.2020
Zobraz více Zobraz méně
 

This document specifies a method for the measurement of 14C activity concentration in all types of water samples by liquid scintillation counting either directly on the test sample or following a chemical separation.

The method is applicable to test samples of supply/drinking water, rainwater, surface and ground water, marine water, as well as cooling water, industrial water, domestic, and industrial wastewater.

The detection limit depends on the sample volume, the instrument used, the sample counting time, the background count rate, the detection efficiency and the chemical recovery. The method described in this document, using currently available liquid scintillation counters and suitable technical conditions has a detection limit as low as 1 Bq l−1, which is lower than the WHO criteria for safe consumption of drinking water (100 Bq·l-1). 14C activity concentrations can be measured up to 106 Bq l-1 without any sample dilution.

It is the user’s responsibility to ensure the validity of this test method for the water samples tested.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 21.03.2020
Zobraz více Zobraz méně
 

This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.

This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 30.03.2020
Zobraz více Zobraz méně
 

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.

NOTE       The functional requirements in this document also apply to inline check valves.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 7.04.2020
Zobraz více Zobraz méně
 

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity of the data. This document is for those who commission, design and perform testing or evaluate the data to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.

This document makes recommendations and offers guidance intended to facilitate further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 8.04.2020
Zobraz více Zobraz méně
 

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

—    details of in vivo sensitization test procedures;

—    key factors for the interpretation of the results.

NOTE       Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.