IS 17717 : Part 2 : 2023
Current
Current
The latest, up-to-date edition.
In-Vitro Diagnostic (IVD) Device-Automated Clinical Chemistry Analyzer - Part 2 Dry Chemistry Analyzer
Published date
01-01-2023
Publisher
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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.
| Committee |
MHD 19
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| DocumentType |
Standard
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| ProductNote |
This standard also refers to IS/IEC 61010-1 : 2010
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| PublisherName |
Bureau of Indian Standards
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| Status |
Current
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| BIS IS/ISO 13485 : 2016 | Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (First Revision)<br> |
| IS/ISO 14971 : 2019 | Medical devices - Application of risk management to medical devices First Revision |
| IS 17724 : Part 1 : 2023 | Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1 General Requirements (IEC 61010-1: 2010 + AMD1:2016 + COR1:2019, MOD) |
| 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 (IEC 61326-2-6 : 2020, MOD) |
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