In its first major revision since the original release in , ISO was updated and approved as an International Standard in October and published in December The following steps should be followed: 1. Perform a risk assessment to understand, evaluate and document the potential for adverse contamination events. Develop a written monitoring plan. Review and approve the plan.
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In its first major revision since the original release in , ISO was updated and approved as an International Standard in October and published in December The following steps should be followed: 1. Perform a risk assessment to understand, evaluate and document the potential for adverse contamination events. Develop a written monitoring plan. Review and approve the plan. Implement the plan by performing the monitoring.
Analyse, trend where appropriate and report performance. Document and implement actions or corrective actions required. Perform periodic reviews of the monitoring plan. However, these supporting tests, that may influence the environment, the monitoring system or the results obtained, should be considered while defining the monitoring plan.
In-operation monitoring ISO has recognised that in-operation monitoring may not be appropriate for processes that inherently produce particles that are of no threat to the process or product. The standard states that, in these cases, it may be appropriate to rely on periodic at-rest classification, or operational classification of simulated operations as opposed to the monitoring of airborne particles in-operation.
General The name of ISO has been updated to Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. The standard is now solely focused on monitoring. The requirement for valid calibration certificates of test equipment is stated in the updated standard including a reference to ISO relating to the calibration of airborne particle counters.
The inclusion of two informative annexes provide guidance on: Developing the mandated monitoring plan including Risk assessment considerations,.
Iso 14644-2 E
If any of the test results exceeds the limits specified, the installation is not in compliance and appropriate remedial action shall be taken. Following remedial action, requalification shall be undertaken. The significance of a change should be determined by agreement between the customer and the supplier. The significance of an interruption should be determined by agreement between the customer and the supplier. The significance of an effect should be determined by agreement between the customer and the supplier. NOTE Monitoring is normally performed with the installation in the operational state. The plan shall include, as a minimum, predetermined sample locations, minimum volume of air per sample, duration of measurements, number of measurements per sample location as required, time interval between measurements, particle size or sizes to be counted, and count acceptance limits, as well as count alert, action and excursion limits, if appropriate.
Download: ISO 14644-3:2015.pdf
Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particulates. It also specifies requirements for the monitoring of a cleanroom or clean zone installation to provide evidence of its continued compliance with ISO for the designated classification of airborne particulate cleanliness. These test methods are specified in the document for two different types of cleanrooms and clean zones; unidirectional flow and nonunidirectional flow. This document is intended for purchasers , suppliers , and designers of cleanroom installations. This standard addresses requirements that are basic to the operation of all cleanrooms, regardless of the application.
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