Category Archives: ISO

ISO/FDIS 14644-13

Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications

Published by: 2017-03-14 / 2017-03-14 / 42 pages
This Draft Standard addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom, and surfaces of materials in a cleanroom. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.

The efficacy of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644-9:2012 and ISO 14644-10:2013.

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ISO 18562-3:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs)

Published by: 2017-04-01 / 2017-04-01 / 20 pages

ISO 18562-3:2017 specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.

ISO 18562-3:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

ISO 18562-3:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.

ISO 18562-3:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series[1].

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

ISO 18562-3:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.

ISO 18562-3:2017 is intended to be read in conjunction with ISO 18562-1.

NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

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ISO 10203:2017

Iron ores – Determination of calcium – Flame atomic absorption spectrometric method

Published by: 2017-04-01 / 2017-04-01 / 20 pages

ISO 10203:2017 specifies a flame atomic absorption spectrometric method for the determination of the mass fraction of calcium in iron ores.

This method is applicable to mass fractions of calcium between 0,010 % and 8,00 % in natural iron ores, iron ore concentrates, and agglomerates, including sinter products.

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ISO 20137:2017

Leather – Chemical tests – Guidelines for testing critical chemicals in leather

Published by: 2017-03-01 / 2017-03-01 / 18 pages

ISO 20137:2017 gives guidelines to apply the available chemical test methods for leather. This information can be used by those involved in setting specifications for leather, especially for those parameters relating to restricted chemical substances.

Lists of restricted chemicals contain many substances that are not relevant to the leather industry. Those chemical substances that are not mentioned in this document do not need to be determined, thus avoiding unnecessary analytical costs.

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ISO 9298:2017

Rubber compounding ingredients – Zinc oxide – Test methods

Published by: 2017-03-01 / 2017-03-01 / 18 pages

ISO 9298:2017 specifies the methods to be used for the evaluation of zinc oxide for use in the rubber industry.

The analytical methods are applicable to all commercial zinc oxides, for example:

– direct type (American process);

– indirect type (French process);

– other types produced by different chemical methods, i.e. precipitation and calcination.

Zinc oxide can also be coated with organic materials, such as fatty acids, oil, wetting agents, etc., in order to improve the dispersion in rubber.

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ISO 15470:2017

Surface chemical analysis – X-ray photoelectron spectroscopy – Description of selected instrumental performance parameters

Published by: 2017-03-01 / 2017-03-01 / 12 pages

ISO 15470:2017 describes the way in which specific aspects of the performance of an X-ray photoelectron spectrometer are described.

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ISO 20378:2017

Welding consumables – Rods for gas welding of non-alloy and creep-resisting steels – Classification

Published by: 2017-03-01 / 2017-03-01 / 10 pages

ISO 20378:2017 specifies a classification for the designation of rods for gas welding of non-alloy and creep-resisting steels in terms of the chemical composition of the rod.

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ISO 2250:2017

Finishing reamers for Morse and metric tapers, with cylindrical shanks and Morse taper shanks

Published by: 2017-02-01 / 2017-02-01 / 10 pages

ISO 2250:2017 specifies the dimensions of cylindrical shank socket reamers and taper shank socket reamers manufactured to produce self-holding taper sockets for self-holding taper shanks of the following designations, and which are in accordance with ISO 296:

– metric tapers no. 4 and no. 6;

– Morse tapers no. 0 to no. 6 inclusive.

NOTE Unless otherwise stated, these reamers are right-hand cutting.

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ISO/TR 20590:2017

Space systems – Debris mitigation design and operation manual for launch vehicle orbital stages

Published by: 2017-02-01 / 2017-02-01 / 42 pages

ISO/TR 20590:2017 contains non-normative information on the design and operational practices for launch vehicle orbital stages for mitigating space debris.

ISO/TR 20590:2017 can be used to guide engineers in the application of the family of space debris mitigation standards (see 4.2) to reduce the growth of space debris by ensuring that launch vehicle orbital stages are designed, operated, and disposed of in a manner that prevents them from generating debris throughout their orbital lifetime.

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