IS 17713 : 2023 In-Vitro Diagnostic (IVD) Device - ELISA Plate Reader
1 SCOPE
This standard specifies the general requirements and the performance test procedure for the in-vitro diagnostic (IVD) instrument - ELISA plate reader also known as microplate reader or photometer. This is used to detect biological, chemical or physical event of sample in microtiter plates.
2 REFERENCES
The standards given below 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 standards.
IS No. Title
IS/ISO 13485 : 2016 Medical devices - Quality management systems - Requirements for regulatory purposes (first revision)
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices (first revision)
IS 17724 Safety requirements for electrical equipment for measurement, control, and laboratory use:
(Part 1) : 2023 General requirements
(Part 4) : 2023 Particular requirements for In-vitro diagnostic IVD medical equipment
IS 17784 Electrical equipment for measurement, control and laboratory use - EMC requirements
(Part 1) : 2023 General requirements
(Part 2) : 2023 Particular requirements for In-vitro diagnostic (IVD) medical equipment