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Helping you understand the quality of LGC-produced reference materials


You might find reference material nomenclature is confusing.  Different manufacturers use similar terms for products that are of differing quality levels.

It is important to us that you understand the quality of LGC’s manufactured products to ensure you source the correct product for your application.

To help, we have summarised the differing types of reference materials produced by LGC.  We have divided them into two broad categories. The first covers ISO/IEC 17025:2005 and ISO15189:2012 applications.  The second covering the specific terminology used in the pharmaceutical manufacturing industry which is driven by the specific uses and regulations within this sector, will be added in the next few weeks.

This information is for your guidance only.  Contact us if you are unsure about the specific product you need for your application, and our reference material experts will be help you make the correct choice.

Reference materials for ISO/IEC 17025:2005  and  ISO15189:2012 applications

Type of reference material

Technical description

Intended use

Primary standard

  • Independently verified standard
  • Sufficiently well characterised
  • Not dependent on traceability

 

  • Forms the basis of a measurement system

Certified reference material (CRM)

  • Characterised by a metrologically valid procedure
  • One or more specified properties certified
  • Accompanied by a certificate that provides the value of the specified property
  • Includes associated uncertainty and statement of metrological traceability
  • Initial calibration and validation of analytical methodologies
  • Occasional monitoring of analytical performance

ISO Guide 34 Reference material

  • Sufficiently homogeneous and stable with respect to one or more specified properties
  • Established to be fit for its intended use in a measurement process
  • Accompanied by a detailed certificate of analysis
  • The development and validation of new analytical methodologies
  • Verification of existing processes
  • Routine use as calibration or control materials

Research chemical

  • Certificate of analysis provides some basic analytical details
  • Identification of target analyte
  • Measurement of analyte where no other reference materials are available

Second source standard

  • Sufficiently homogeneous and stable with respect to one or more specified properties
  • Established to be fit for its intended use in a measurement process
  • Accompanied by a detailed certificate of analysis
  • Routine use as calibration or control materials
  • Used in conjunction with and ISO Guide 34 Reference Material

CE marked products

  • Conformity marking for products sold within the European Economic area
  • Self certified by the manufacturer
  • Not necessarily associated with any specific external quality system requirements
  • Primarily used for reference material used to satisfy the requirements of the In vitro diagnostic (IVD) directive

 

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