Helping you understand the quality of LGC-produced reference materials

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