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Core Purpose

Notification by the Bureau of Indian Standards establishing five new Indian Standards for surgical implants under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018.

Detailed Summary

The Bureau of Indian Standards (Department of Consumer Affairs), vide reference HQ-PUB013/1/2020-PUB-BIS (910) dated 13th June 2024, notifies under sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018, the establishment, effective 11th June 2024, of five Indian Standards: IS 12375 (Part 12):2024 'Implants for Surgery - Partial and Total Hip Joint Prostheses, Part 12 Deformation Test Method for Acetabular Shells' (based on ISO 7206-12:2016, MOD); IS 12375 (Part 13):2024 'Implants for Surgery - Partial and Total Hip Joint Prostheses, Part 13 Determination of Resistance to Torque of Head Fixation of Stemmed Femoral Components' (ISO 7206-13:2016, MOD); IS 18074 (Part 3):2024 'Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene, Part 3 Accelerated Ageing Methods' (ISO 5834-3:2019, MOD); IS 18074 (Part 5):2024 'Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene, Part 5 Morphology Assessment Method' (ISO 5834-5:2019); and IS 18592 (Part 2):2024 'Non-Active Surgical Implants - Implant Coating, Part 2 Reference Standards Related to Coatings' (ISO/TR 17327-2:2021); none of the entries lists any prior standard being withdrawn, and the notification is signed by P. Rajesh, Scientist G & DDG (ITS, PRT & TNM), under reference ADVT.-III/4/Exty./212/2024-25.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-27062024-254991 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 443] NEW DELHI, WEDNESDAY, JUNE 26, 2024/ASHADHA 5, 1946 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 13th June, 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (910).—In pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Indian standards, particulars of which are given in the second column of the schedule hereto annexed have been established on the date indicated against it in third column. The particulars of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column. SCHEDULE +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | Sl.No.| No., Year & Title of the Indian Standards Established | Date of Establishment | No., Year & Title of the Indian Standards to be | Date of Withdrawal | | | | | Withdrawn, if any | | +=======+==================================================================================================================+========================+====================================================+=====================+ | (1) | (2) | (3) | (4) | (5) | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | 1 | IS 12375 (Part 12): 2024 | 11 June 2024 | NA | NA | | | Implants for Surgery - Partial | | | | | | and Total Hip Joint Prostheses | | | | | | Part 12 Deformation Test Method | | | | | | for Acetabular Shells | | | | | | (ISO 7206-12 : 2016, MOD) | | | | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | 2 | IS 12375 (Part 13): 2024 | 11 June 2024 | NA | NA | | | Implants for Surgery - Partial | | | | | | and Total Hip Joint Prostheses | | | | | | Part 13 Determination of | | | | | | Resistance to Torque of Head | | | | | | Fixation of Stemmed Femoral | | | | | | Components | | | | | | (ISO 7206-13 : 2016, MOD) | | | | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | 3 | IS 18074 (Part 3): 2024 | 11 June 2024 | NA | NA | | | Implants for Surgery — Ultra- | | | | | | High-Molecular-Weight | | | | | | Polyethylene | | | | | | Part 3 Accelerated Ageing | | | | | | Methods | | | | | | (ISO 5834-3: 2019, MOD) | | | | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | 4 | IS 18074 (Part 5) : 2024 | 11 June 2024 | NA | NA | | | ISO 5834-5:2019 | | | | | | Implants for Surgery — Ultra- | | | | | | High-Molecular-Weight | | | | | | Polyethylene | | | | | | Part 5 Morphology Assessment | | | | | | Method | | | | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ | 5 | IS 18592 (Part 2): 2024 | 11 June 2024 | NA | NA | | | ISO/TR 17327-2: 2021 | | | | | | Non-Active Surgical Implants — | | | | | | Implant Coating | | | | | | Part 2 Reference Standards | | | | | | Related to Coatings | | | | +-------+------------------------------------------------------------------------------------------------------------------+------------------------+----------------------------------------------------+---------------------+ P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./212/2024-25]

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