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IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-2015
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 ProceduresAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/ECBibliography
Pertains to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents.
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