BIS issued the date of establishment of the In-Vitro Diagnostic (IVD) Device

Jan 04, 2024 | by TeamLease RegTech Legal Research Team

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Commercial ComplianceThe Bureau of Indian Standards (BIS) on January 02, 2024, issued the date of establishment of the In-Vitro Diagnostic (IVD) Device.

The following Indian Standards were established on December 28, 2023:

• IS 17717 (Part 1): 2023 In-Vitro Diagnostic (IVD) Device — Automated Clinical Chemistry Analyzer Part 1 Wet Chemistry Analyzer

• IS 17717 (Part 2): 2023 In-Vitro Diagnostic (IVD) Device — Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer

• 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)

• IS 18518: 2023 Bullet Resistant Security Glass — Quality and Performance Requirements

[Notification No. HQ-PUB013/1/2020-PUB-BIS (763)]


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