IS 17721 : 2024 In-Vitro Diagnostic (IVD) Devices - Electrolyte Analyzer

1 SCOPE

This standard provides basic requirements and standard test procedures for performance testing of in-vitro diagnostic (IVD) medical device - electrolyte analyzer that measures sodium, potassium, chloride, lithium, ph, bicarbonate and ionized calcium in whole blood, serum, plasma, urine, dialysate or other biological fluids, using ion selective electrode technology.

2 REFERENCES

The standards listed in Annex A contain provisions which, through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent edition of these standard.