Pregled nacrta

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.

This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which may substitute, or complement services defined in ISO 21388, and it defines services which shall be provided in the facilities of the HAP. Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this standard without further notice. Furthermore, it is tried to keep the structure if ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. 
Other assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related will also be outside of the scope.

This European Standard specifies the laboratory method for measuring the sound absorption performance of road traffic noise reducing devices in reverberant conditions. It covers the assessment of the intrinsic sound absorption performance of devices that can reasonably be assembled inside the testing facility described in EN ISO 354.
This method is not intended for the determination of the intrinsic characteristics of sound absorption of noise reducing devices to be installed on roads in non-reverberant conditions.
The test method in EN ISO 354 referred to in this European Standard excludes devices that act as weakly damped resonators. Some devices will depart significantly from these requirements and in these cases, care is needed in interpreting the results.

This document specifies the laboratory method for measuring the airborne sound insulation performance of road traffic noise reducing devices in reverberant conditions. It covers the assessment of the intrinsic performance of barriers that can reasonably be assembled inside the testing facility described in EN ISO 10140-2 and EN ISO 10140-4.
This method is not intended for the determination of the intrinsic characteristics of airborne sound insulation of noise reducing devices to be installed on roads in non-reverberant conditions.

This part of prEN 1793 gives a normalized traffic noise spectrum for the evaluation and assessment of the acoustic performance of devices designed to reduce traffic noise near roads.

This European Standard describes a test method for measuring a quantity representative of the intrinsic characteristics of sound reflection from road noise reducing devices: the reflection index.
The test method is intended for the following applications:
- determination of the intrinsic characteristics of sound reflection of noise reducing devices to be installed along roads, to be measured either on typical installations alongside roads or on a relevant sample section;
- determination of the in situ intrinsic characteristics of sound reflection of noise reducing devices in actual use;
- comparison of design specifications with actual performance data after the completion of the construction work;
- verification of the long-term performance of noise reducing devices (with a repeated application of the method).
The test method is not intended for the following applications:
- determination of the intrinsic characteristics of sound reflection of noise reducing devices to be installed in reverberant conditions, e.g. inside tunnels or deep trenches.
Results are expressed as a function of frequency, in one-third octave bands between 100 Hz and 5 kHz. If it is not possible to get valid measurements results over the whole frequency range indicated, the results shall be given in a restricted frequency range and the reasons of the restriction(s) shall be clearly reported.

This document specifies the requirements for testing, drying, purging, cool-down and decommissioning of refrigerated liquefied gas storage tanks.
This document deals with the design and manufacture of site built, vertical, cylindrical, flat-bottomed tank systems for the storage of refrigerated, liquefied gases with operating temperatures between 0 °C and -196°C.

This document defines the specific test procedures for different type of SGDs: metallic, textile fabric, non-metallic net and hybrid.

This document specifies the control of the production (either self monitoring or by a third-party), which is a common part for every manufacturer of every kind of supplementary grip device (SGD).

ISO 4628-3:2016 specifies a method for assessing the degree of rusting of coatings by comparison with pictorial standards.
The pictorial standards provided in this part of ISO 4628 show coated steel surfaces which have deteriorated to different degrees by a combination of rust broken through the coating and visible underrust.
NOTE 1 The pictorial standards have been selected from the "European rust scale" published by the European Confederation of Paint, Printing Ink and Artists' Colours Manufacturers' Associations (CEPE), Brussels. The correlation between the ISO scale and the "European rust scale" is given in Annex B, Table B.1.
NOTE 2 The correlation between the ISO scale and the rating system of ASTM D 610 is given in Annex B, Table B.2.
NOTE 3 The rust formation on uncoated steel surfaces is designated in accordance with ISO 8501‑1 (rust grades A, B, C, and D).
ISO 4628‑1 defines the system used for designating the quantity and size of defects and the intensity of changes in appearance of coatings and outlines the general principles of the system. This system is intended to be used, in particular, for defects caused by ageing and weathering, and for uniform changes such as colour changes, for example yellowing.

This document specifies a method for the determination of total organic carbon (TOC), dissolved organic carbon (DOC), total bound nitrogen (TNb) and dissolved bound nitrogen (DNb) in the form of free ammonia, ammonium, nitrite, nitrate and organic compounds capable of conversion to nitrogen oxides under the conditions described. The procedure is carried out instrumentally.
NOTE       Generally the method can be applied for the determination of total carbon (TC) and total inorganic carbon (TIC), see Annex A.
The method is applicable to water samples (e.g. drinking water, raw water, ground water, surface water, sea water, waste water, leachates).
The method allows a determination of TOC and DOC ≥ 1 mg/l and TNb and DNb ≥ 1 mg/l. The upper working range is restricted by instrument-dependent conditions (e.g. injection volume). Higher concentrations can be determined after appropriate dilution of the sample.
For samples containing volatile organic compounds (e.g. industrial waste water), the difference method is used, see Annex A.
Cyanide, cyanate and particles of elemental carbon (soot), when present in the sample, can be determined together with the organic carbon.
The method is not appropriate for the determination of volatile, or purgeable, organic carbon under the conditions described by this method.
Dissolved nitrogen gas (N2) is not determined.

This document defines terms relating to corrosion that are widely used in modern science and technology. In addition, some definitions are supplemented with short explanations.
NOTE 1 Throughout the document, IUPAC rules for electrode potential signs are applied. The term "metal" is also used to include alloys and other metallic materials.
NOTE 2 Terms and definitions related to the inorganic surface treatment of metals are given in ISO 2080.

This document addresses the following:

a)    the confidentiality of personal information for the customer and the laboratory;

b)    the laboratory safety requirements;

c)    the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from CBMN assay yields and the detection limit;

d)    the performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring;

e)    the scoring criteria;

f)     the conversion of micronucleus frequency in BNCs into an estimate of absorbed dose;

g)    the reporting of results;

h)    quality assurance and quality control;

i)     informative annexes containing sample instructions for customers, sample questionnaire, a microscope scoring data sheet, and a sample report.

ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8362-2:2015 are intended for single use only.

This document specifies the gas chromatographic (GC) method for the determination of saturated, olefinic and aromatic hydrocarbons in automotive motor gasoline and ethanol (E85) automotive fuel. Additionally, the benzene and toluene content, oxygenated compounds and the total oxygen content can be determined.
NOTE 1   For the purposes of this document, the terms % (m/m) and % (V/V) are used to represent respectively the mass fraction, w, and the volume fraction, φ.
This document defines two procedures, A and B.
Procedure A is applicable to automotive motor gasoline with total aromatics of 19,32 % (V/V) up to 46,29 % (V/V); total olefins from 0,40 % (V/V) up to 26,85 % (V/V); oxygenates from 0,61 % (V/V) up to 9,85 % (V/V); oxygen content from 1,50 % (m/m) to 12,32 % (m/m); benzene content from 0,38 % (V/V) up to 1,98 % (V/V) and toluene content from 5,85 % (V/V) up to 31,65 % (V/V).
The method has also been tested for individual oxygenates. A precision has been determined for a total volume of methanol from 1,05 % (V/V) up to 16,96 % (V/V); a total volume of ethanol from 0,50 % (V/V) up to 17,86 % (V/V); a total volume of MTBE from 0,99 % (V/V) up to 15,70 % (V/V), a total volume of ETBE from 0,99 % (V/V) up to 15,49 % (V/V), a total volume of TAME from 0,99 % (V/V) up to 5,92 % (V/V), and a total volume of TAEE from 0,98 % (V/V) up to 15,59 % (V/V).
Although this test method can be used to determine higher-olefin contents of up to 50 % (V/V), the precision for olefins was tested only in the range from 0,40 % (V/V) to 26,85 % (V/V).
Although specifically developed for the analysis of automotive motor gasoline that contains oxygenates, this test method can also be applied to other hydrocarbon streams having similar boiling ranges, such as naphthas and reformates.
NOTE 2   For Procedure A, applicability of this document has also been verified for the determination of n-propanol, acetone, and di-isopropyl ether (DIPE). However, no precision data have been determined for these compounds.
Procedure B describes the analysis of oxygenated groups (ethanol, methanol, ethers, C3 – C5 alcohols) in ethanol (E85) automotive fuel containing ethanol between 50 % (V/V) and 85 % (V/V). The gasoline is diluted with an oxygenate-free component to lower the ethanol content to a value below 20 % (V/V) before the analysis by GC.
The sample can be fully analysed including hydrocarbons. Precision data for the diluted sample are only available for the oxygenated groups.
NOTE 3   For Procedure B, the precision can be used for an ethanol fraction from about 50 % up to 85 % (V/V). For the ether fraction, the precision as specified in Table 6 can be used for samples containing at least 11 % (V/V) of ethers. For the higher alcohol fraction, too few data were obtained to derive a full precision statement and the data presented in Table 6 are therefore only indicative.
NOTE 4   An overlap between C9 and C10 aromatics can occur. However, the total is accurate. Isopropyl benzene is resolved from the C8 aromatics and is included with the other C9 aromatics.