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Bis Standards Index

This page provides links and references to Bureau of Indian Standards (BIS) specifications and requirements applicable to medical devices, along with CDSCO adoption notices.

Official sources: CDSCO; SUGAM portal; Bureau of Indian Standards; IMDRF

BIS Standards Index Overview

BIS Standards Index Overview

What are BIS Standards? The Bureau of Indian Standards (BIS) develops and publishes Indian Standards that are referenced in the Medical Devices Rules 2017. Many medical devices must comply with applicable BIS standards as part of their manufacturing and quality requirements.

How to use this index:

  1. Identify your device type or intended use
  2. Cross-reference applicable BIS standards
  3. Obtain full standard document from BIS (may require purchase)
  4. Ensure manufacturing processes and testing align with standard requirements
  5. Document compliance during regulatory submissions

Key BIS standards for medical devices:

  • IS 13601 – Blood bank equipment
  • IS 8846 – Medical gas cylinders
  • IS 14969 – Sterilization of medical devices
  • (Additional standards organized by device category)

Official resources: CDSCO; Bureau of Indian Standards; IMDRF