BIS IS/ISO 13485 : 2016
Current
Current
The latest, up-to-date edition.
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (First Revision)
Published date
01-01-2016
Publisher
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| Committee |
MHD 14
|
| DevelopmentNote |
Supersedes BIS IS 15579. (08/2010) 2003 Edition is still active. (10/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Bureau of Indian Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| IS 17714 : 2023 | In-Vitro Diagnostic IVD Devices - Automated Elisa Processor |
| IS 17717 : Part 2 : 2023 | In-Vitro Diagnostic (IVD) Device-Automated Clinical Chemistry Analyzer - Part 2 Dry Chemistry Analyzer |
| IS 17715 : 2023 | In-vitro Diagnostics (IVD) Device - ELISA Plate Washer |
Summarise
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