Containment minimum performance standard

Briem et al. [33] also describe the use of a liquid handler to perform the sample preparation steps in an automated manner. The sample preparation consisted in taking a 25 pL aliquot of the plasma sample and adding 150 pL of acetonitrile (ACN) containing the internal standard (IS) and then following typical protein precipitation (PPT) procedure steps. The authors noted that the 1 6 ratio of plasma to ACN worked well for the liquid handler and exceeded the 1 3 criterion reported by Poison et al. [34] as the minimum ratio of plasma to ACN needed to remove at least 96% of the proteins from the plasma sample. The authors also noted that use of EDTA (instead of heparin) as the anticoagulant helped to avoid clots in plasma as has been reported previously by other authors [35-37], The authors also stated that the robotic method... 

What furnace engineers most need is a closed-form solution of the problem, theoretically sound in structure and therefore containing a minimum number of parameters and no empirical constants and, preferably, physically visuaHzable. They can then (1) correlate data on existing furnaces, (2) develop a performance equation for standard design, or (3) estimate performance of a new furnace type on which no data are available. 

Subcontractor development should not be limited to the assessment for compliance to ISO/TS 16949 as indicated in Note 1. The standard contains the minimum requirements and, with the requirement for continuous improvement, it may be necessary to work with some of your subcontractors in order to develop their capability to improve process capability and delivery schedules or reduce avoidable costs. You can t develop all your subcontractors and hence Note 2 of the standard indicates that you should prioritize subcontractors for development based upon performance and importance of product or service supplied. 

Analyses are performed to determine the identity and quality of a reaction component. Simple tests are preferred as identity tests, such as pH measurement, titration, suitable comparison of IR spectra to standard spectra, boiling point, refractive index, and others. The quality of components can be assessed by many methods and compared to a standard. Often a standard is set to require that material be no less than a minimum purity, such as 96%. Specifications may also be set to require that a component contain no more than a given level of a specific impurity. By correlating the processing characteristics with product yield and quality, data can be gathered to establish suitable specifications for all components of a process. 

Product safety certification agencies use various types of safety standards to evaluate engineering products. These standards are documents that clearly define the products minimum construction and performance requirements with respect to safety. All types of electrically operated medical equipment/ devices used in the United States are evaluated according to standard UL 2601-1 (lEC 60601-1) [14-17]. The UL 2601-1 safety standard contains the full text of lEC 60601-1 in addition to the US. deviations [14]. The US. deviations contain items such as the following [14] ... 

Performance using a particular method for CDU determinations is assumed to be equivalent to the performance reported by the research laboratories in which the method was developed. Pruszkowska et al. (1983) report a detection limit of 0.04 pg/l CDU, with a CV of <4% between 0-5 pg/l. The CDC reports a minimum CDU detection limit of 0.07 pg/l using a modified method based on Pruszkowska et al. (1983). No CV is stated in this protocol the protocol contains only rejection criteria for internal QC parameters used during accuracy determinations with known standards (Attachment 8 of exhibit 106 of OSHA docket H057A). Stoeppler and Brandt (1980) report a CDU detection limit of 0.2 pg/l for their methodology. 

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