BIS notified regarding establishment of the amendment to IS Sterilization of Health Care Products

Jun 03, 2024 | by TeamLease RegTech Legal Research Team

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Commercial ComplianceThe Bureau of Indian Standards (BIS) on May 30, 2024, issued a notification regarding the amendment to Indian Standard (IS) Sterilization of Health Care Products — Radiation Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

The amendment of the following IS has been Established on May 21, 2024, namely: -

• IS/ISO 11137-1 : 2006 Sterilization of Health Care Products — Radiation Part 1 Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices – Amendment No. 2 May 2024

The IS shall stay in force without the amendment till June 20, 2024.

[Notification No. HQ-PUB015/1/2020-PUB-BIS (896)]


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