BIS Revises Standards for Medical Textiles, Medical Devices and Metals

LegalitySimplified

The Bureau of Indian Standards (BIS) has revised certain standards for Medical Textiles, Medical Devices, Steels, Malleable Iron Shots and Grits and Metallic and Other Inorganic Coatings. These notifications were published on December 6 & 11, 2023.

The revised standards are as follows:

  • Medical Textiles — Cotton Bandage Cloth — Specification (Third Revision)
  • Steels — Determination of the Depth of Decarburization (Third Revision) and
  • Malleable Iron Shots and Grits for Use in Foundries — Specification (First Revision)

All of the above standards stand established on November 21, 2023. However, the previous version of the standard on Steels is withdrawn from February 21, 2024. However, all previous versions of the other abovementioned standards stand withdrawn from May 21, 2024.

Furthermore, BIS has also revised the standard on Medical Devices Part 1 Application of Usability Engineering (IS 17922 (Part 1) : 2023/IEC 62366-1 : 2015 + AMD 1 : 2020). The prior standards stands withdrawn from December 23, 2023.

It has additionally introduced the following new standards:

  • Basic Semen Examination — Specification and Test Methods
  • Medical Devices — Post-Market Surveillance for Manufacturers
  • Metallic and Other Inorganic Coatings — Post-Coating Treatments of Iron or Steel to Reduce the Risk of Hydrogen Embrittlement and
  • Metallic and Other Inorganic Coatings — Pretreatment of Iron or Steel to Reduce the Risk of Hydrogen Embrittlement

All of these standards have been established on November 23, 2023.

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