IS 17717 : Part 2 : 2023 In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer - Part 2 Dry Chemistry Analyzer
1 SCOPE
This part of Indian standard provides basic requirements and standard test procedures for performance testing of In-Vitro diagnostic (IVD) instruments - Automated clinical chemistry Analyzers also known as Biochemistry Analyzers including random access, high throughput fully automated clinical chemistry analysers for dry chemistry analyzer only.
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/IEC 61010-1 : 2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| IS/ISO 13485 : 2016 | Medical Devices - Quality management systems - Requirements for regulatory purposes (first revision) |
| IS/ISO 14971 : 2007 | Medical devices - Application of risk management to medical devices |
| IS 17724 (Part 4) : 2023 | Safety requirements for electrical equipment for measurement, control, and laboratory use: Part 4 Particular requirements for invitro diagnostic (IVD) medical equipment |
| IS 17784 (Part 2) : 2023 | Electrical equipment for measurement, control and laboratory use - EMC requirements: Part 2 Particular requirements for in-vitro diagnostic (IVD) medical equipment |