IS 17720 : 2023 In-vitro Diagnostic (IVD) Medical Device - Automated Blood Culture and Microbial Detection System
1 SCOPE
This standard covers the requirements of device used for diagnosing bloodstream infections (BSIs) by detecting the growth of microorganisms in the blood culture.
2 REFERENCES
The standard 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 the standard are encouraged to investigate the possibility of applying the most recent edition of these standards:
| IS No. | Title |
| IS 17724 | Safety requirements for electrical equipment for measurement, control, and laboratory use: |
| (Part 1) : 2023 | General requirements |
| (Part 3) : 2023 | Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes |
| (Part 4) : 2023 | Particular requirements for In-vitro diagnostic IVD medical equipment |
| 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 |
| IS/ISO 15190 : 2003 | Medical Laboratories - Requirements for Safety |
| IS/ISO 23640 : 2011 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents |