Notified bodies defined

The FDA s access to documentation supporting the QAP and reports must be defined in an SOR All corrective actions are open for inspection under the International Standards Organization (ISO) certification. The ISO notified body is not concerned with regulatory follow-up, as is required by the FDA. 

Besides the certificate of conformity, there is a rather less common way of certification the control certificate. This relates to apparatus not complying with Harmonized European Norms (HN). It is the decision of a notified body to ensure the equivalent level of safety with respect to well-defined types of protection according to the HN. The notified body informs all other notified bodies after an appropriate safety assessment. If there is no contradiction within a 4-month period, the notified body issues the control certificate. 

The European bodies (especially in Germany) issue certified approvals and marks according to clearly defined standards, which are definitive statements on their assessment results. The European approval term means that the equipment bearing an approval mark has been successfully tested and passed, but more important, approvals are perceived by users and customers as a guarantee that the equipment is safe for use (see Notified Bodies and Certification in Chapter 4). 

Photoelectric safety devices are safety components , as defined in the Supply of Machinery Safety Regulations 1992. A notified body, who will use BS EN 61496 as the baseline standard, must therefore check their conformity with the Regulations. The standard lays down general requirements for electrosensitive protective equipment, in Part 1, with Part 2 specifying particular requirements for photoelectric systems. For example, the standard specifies two types of device according to their fault tolerance. Type 2 and Type 4 ... 

According to GE and Penn State, an additional component of the sample collection is associated with the temperature of the human body generating a human convection plume [32,34], The plume is said to promote a natural upward convection of air along the entire body at a rate of 0.3-0.5 m/s, with a volumetric flow equal to the fan flow of 501/s. With this portal design, when a pure explosive vapor is released in the portal sampling space 25% of the vapor is captured and detected [32], After the person has been screened, the operator is notified through audile and/or visual indicators on an interface computer screen on the exit side of the portal. If the person is cleared, the door swings open to allow exit. A complete cycle for this portal, defined from the time the person stops inside the portal to a notification to the operator, is 15-20s. 

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