Certification - meaning

Paragraph 1 certification means a certification that a generic applicant seeks FDA approval of its ANDA for a relevant NDA for which no patent information has been filed in the Orange Book. 

Paragraph fV certification means a certification that a patent listed in the Orange Book is invalid or will not be infringed by the generic drug for which the ANDA applicant seeks approval. 

The local PIC procedures require at least two visits to the field, a minimum consultation period of 60 days and the provision of animals for rituals, especially when the site of collection is within indigenous territories. The 60-day consultation period to secure the PIC certificate means that obtaining a collection permit takes at least five months, which delays the IACBGR approval process even further. 

Certification means to formally demonstrate system acceptability to obtain authorization to use the system operationally. In terms of software reliability, it means to evaluate whether the reliability requirement is met or not. 

A certificate is a visible form of attestation through an independent and impartial third party. Certification means that a product or service conforms to certain technical rules contained in standards or regulations. 

Following extensive testing and evaluation, the biocide additive has been approved for food contact by the US organization NSF International. The certification means that the additive meets the requirements of ANSI/NSF Standard 51, covering safety of plastics materials and components developed for contact with food in the USA. The NSF mark can now be featured on products containing the ingredient and in promotional literature and will also encourage manufacturers of food equipment, who already hold NSF approval, to use the additive in their products. 

Respirators are certified by NIOSH. Conditions of certification means limitations of use stated by NIOSH that accompany the certification. Parts from other manufacturers or models cannot be substituted. 

The combination of hardware and software certification means that the end user can obtain a fully certified product for the logic solver section of the SIS. This does not of course relieve the end user of any obligations as far as the quality of his software application/configuration... 

Certification Certification means the legal recognition by the certification authority that a product, service, organisation or person complies with the applicable requirements. Such certification comprises the activity of technically checking the product, service, organisation or person and the formal recognition of compliance with the applicable requirements by issue of a certificate, licence, approval or other documents as required by national laws and procedures. In particular, certification of a product involves ... 

Provides for the control of fire safety m all designated occupied premises, by ensuring that adequate general fire precautions are taken and appropriate means of escape and related precautions are present. Specifies the requirements for a fire certificate for various premises. 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

The Health and Safety at Work Act 1974 gives the relevant fire authority the power to designate a place of work as premises requiring a fire certificate. This certificate will indicate the measures to be taken with respect to means of escape in the event of a fire when the structural design of... 

Other authors used a simple 2 standard deviation criteria or an outlier test (F-test) to check for significant differences between within-bottle and between-bottle results (Martin-Esteban et al. 1997 Quevauviller et al. 1995). The degree of homogeneity of elements and compounds in the materials tested in these studies does not seem to be adequately described and, hence, the asigned uncertainties in the mean values may represent only the bias between the analytical methods used in the certification. 

Particularly for direct microanalytical techniques using <10 mg of sample for analysis, it is highly desirable to obtain quantitative information on element- and compound-specific homogeneity in the certificates for validation and quality control of measurements. As the mean concentration in a CRM is clearly material-related, the standard deviation of this mean value should represent the element s distribution in this matrix rather than differences in the analytical procedures used. 

As the uncertainty of the mean is now related to the mass used for analysis and it is based on a careful evaluation of the element distribution in the material, this approach could help to evaluate further the total uncertainty budget for various analytical techniques as is required in accreditation and certification campaigns. 

The Standards, Measurements and Testing Programme of the European Commission launched a few years ago a project dealing with the development and, ultimately, the production of air filters realistically exposed to welding dust occurring during stainless steel welding (Christensen et al. 1999). This project resulted in the production and certification of a batch of 1100 filters for the Cr (VI) content (40.16 0.60 pg/g dust) (CRM 545). In addition, the total leachable Cr content ( 39.37 1.30 pg/g dust) was certified as a means to check for total Cr recovery. 

The third invention reported by the authors [19] was related to sulfur oxidation, but the invention was not patented. It was only registered with the Statutory Invention Registration (SIR). What this means is that, it is not a utility patent as the rest of the documents considered in this Chapter, rather a SIR registered document containing the specification and drawings of a provisional application filed for a patent, which has not been subjected to examination yet. It is issued by the PTO, if the applicant, among other requirements, waives the right to receive a patent on the invention within such period as may be prescribed by the Commissioner. The invention such as this, on which a statutory invention certificate is published, is not a patented invention for most purposes. 

Local certification has a number of advantages, not least that it is one way to reduce costs to producers in developing countries via locally determined fees reflecting local incomes (Barrett et al., 2001). To be accepted by the European Union (EU), local certification bodies are required to demonstrate that their standards of organic production and inspection are equivalent to EU regulations. The standards need not necessarily be identical, however, and as such this means more locally appropriate standards can be set in place. For example, local certification bodies may well allow the use of such natural pesticides that would not normally be allowed under EU Standards (Myers, 2000). 

Type B obtained by means other than statistical analysis of results (e.g. data from calibration certificates, manufacturers specifications, modelling, etc.). 

Lee and Chau [66] have discussed the development and certification of a sediment reference material for total polychlorobiphenyls. Alford Stevens et al. [49] in an inter-laboratory study on the determination of polychlorobiphenyls in environmentally contaminated sediments showed the mean relative standard deviation of measured polychlorobiphenyl concentrations was 34%, despite efforts to eliminate procedural variations. Eganhouse and Gosset [67] have discussed the sources and magnitude of bias associated with the determination of polychlorobiphenyls in environmental sediments. Heilman [30] studied the adsorption and desorption of polychlorobiphenyl on sediments. 

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