ISO 16232-3 PDF

ISO Method of extraction of contaminants by agitation. ISO Method of extraction of contaminants by pressure rinsing. Find the most up-to-date version of ISO at Engineering This British Standard was published by BSI. It is the UK implementation of. ISO The UK participation in its preparation was.

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Details of the procedure shall be reported on a suitable data sheet for an example of an extraction procedure data sheet see Annex B. Method of extraction of contaminants by ultrasonic techniques ISORoad vehicles — Cleanliness of components of fluid circuits — Part 5: This requirement may result in the test being carried out in a laboratory or isl workplace.

Take the smart route to manage medical device compliance. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.

If the particles detached during transportation of the test component and particles from the packaging have to be included in the cleanliness test, they shall be collected using the appropriate extraction method e.

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BS-ISOMethod of extraction of contaminants by pressure rinsing_百度文库

If this is the case, it is ensured that all extraction parameters have been properly investigated. A list of organizations represented on this committee can be obtained on request to its secretary.


For example, by performing a cleanliness analysis of a defined volume of liquid after the cleaning procedure of the set-up, it can be determined whether the inspection environment is in suitable conditions and acceptable for carrying out a validation procedure.

Method of extraction of contaminants by pressure rinsing ICS You may find similar items within these categories by selecting from the choices below:.

The suitability of the environment is validated when performing the blank test. This simplified method shall be validated and shall be agreed between parties and included in the inspection document. ISO shall not be held responsible for identifying any or all such patent rights.

Particle sizing and counting by automatic light extinction particle 116232-3 ISO Cleanliness of components of fluid circuits.

When components are heavy or large, they should be manipulated and moved to a suitable position with appropriate supports e. Method of extraction of contaminants by pressure rinsing. Follow the precautions for safe handling and usage as described in the MSDS available from the supplier.

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BS ISO 16232-3:2007

The external surface should be cleaned in a physically different place from where extraction is to be carried out. It is incorporated by Royal Charter. In order to achieve reliable performance of components and systems, control over the amount of particles introduced during the build phase is necessary, and measurement of particulate contaminants is the basis of control.


NOTE The sizes specified in the inspection document for the blank should be as close as possible to the maximum particle size acceptable for the component and chosen to allow counting significant numbers of particles.

NOTE Dismantling or removal of plugs might generate particles to contribute to the original contamination. This position shall enable the extraction liquid to flow easily into a collection equipment or sampling container.

On reconstruction of a All collection equipment shall be cleaned and covered before use in order to limit contamination from the environment. Particle mass determination by gravimetric analysis ISORoad vehicles — Cleanliness of components of fluid circuits — Part 7: The initial blank shall exhibit values stated in 6.

Main sources of blank contamination are: Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. NOTE 3 In some cases for example: Appropriate precautions should be taken to avoid inhalation of fumes from these solvents.