IS 17719 : 2023 In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument
1 SCOPE
This standard provides basic requirements and standard test procedures for the performance testing of In-Vitro Diagnostics (IVD) instruments - Automated slide staining instrument.
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 editions 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/ISO 15223-1 : 2016 | Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 1 General requirements (second revision) |
| IS/IEC 61010-1 : 2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use: Part 1 General requirements |
| IS/ISO 62304 : 2015 | Medical device software - Software life cycle processes |
| IS/IEC 62366-1 : 2015 | Medical devices: Part 1 Application of usability engineering to medical devices |