IS 17716 : 2024 In-vitro Diagnostic (IVD) Device - Blood Gas Analyzers
1 SCOPE
The standard describes the specifications and standard testing procedure for the performance evaluation of blood gas analyzers.
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 standard:
| IS No. | Title |
| IS/ISO 9000 : 2015 | Quality management systems - Fundamentals and vocabulary (fourth revision) |
| 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 15393 (Part 3) : 2003/ISO 5725-3 : 1994 | Accuracy (trueness and precision) of measurement methods and results: Part 3 Intermediate measures of the precision of a standard measurement method |
| IS 17724 | Safety requirements for electrical equipment for measurement, control, and laboratory use: |
| (Part 1) : 2023 | General requirements (IEC 61010-1: 2010 + AMD1 : 2016 + COR1 : 2019, MOD) |
| (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 (IEC 61326-1 : 2020, MOD) |
| (Part 2) : 2023 | Particular requirements for In-vitro diagnostic (IVD) medical equipment |