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Revised Standards : MHD 14


S.No. IS Number IS Title Revision Number Category Document Comment
1 IS 12377 : 2016 Classification and matrix for various categories of hospitals (First Revision) 1 Code of Practice  Download
2 IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) 1 System Standard  Buy
3 IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision 1 Product Specification  Download
4 IS/ISO 15189 : 2022 Medical Laboratories Requirements for Quality and Competence Third Revision 3 ------  Buy
5 IS/ISO 15223 : Part 1 : 2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) 2 Code of Practice  Buy
6 IS/ISO/TR 24971 : 2020 Medical Devices Guidance on the Application of ISO 14971 (First Revision) 1 ------  Buy