Bureau of Indian Standards

In pursuance of Sub rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards

Issue Date: 29 January 2025 Published: 31 January 2025

Gazette ID: CG-DL-E-31012025-260619 Download PDF

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Core Purpose

Bureau of Indian Standards notifies the establishment of new Indian Standards and withdrawal of existing standards for various medical and dental instruments and equipment.

Detailed Summary

This notification from the Bureau of Indian Standards (BIS) announces the establishment of new Indian Standards, effective from January 14, 2025, as listed in the schedule. It also specifies the withdrawal of corresponding older Indian Standards, where applicable, effective from July 14, 2025. The standards cover a range of medical and dental instruments, equipment, and related testing methodologies. Key areas include neurosurgical instruments, dental instruments like forceps, cutters, toothbrushes, and equipment for medical suction and dental implant systems. Some standards also address biocompatibility evaluation for healthcare applications and testing methods for materials used in surgery. For some newly established standards, there are no corresponding standards being withdrawn, indicated as 'NA' in the schedule.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-31012025-260619 EXTRAORDINARY PART III-Section 4 PUBLISHED BY AUTHORITY No. 74] NEW DELHI, WEDNESDAY, JANUARY 29, 2025/MAGHA 9, 1946 BUREAU OF INDIAN STANDARDS (Department Of Consumer Affairs) New Delhi, the 17th January, 2025 Ref: HQ-PUB013/1/2020-PUB-BIS (1147).— 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of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column.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.p| No., Year & Title of the Indian | Date of | No., Year & Title of the | Date of | | No. | Standards Established | Establishment | Indian Standards to be | Withdrawal | | | | | Withdrawn, if any | | +=====+=================================================================================+===================+=================================================================================+==================+ | (1) | (2) | (3) | (4) | (5) | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 1 | IS 8175: 2025 | 14 January 2025 | IS 8175: 1994 | 14 July 2025 | | | Neurosurgical Instruments - | | Neurosurgical Instruments - | | | | Forceps, Artery, Straight and | | Forceps, Artery, Straight and | | | | Curved on Flat, Hugh Cairn's | | Curved on Flat, Hugh Cairn's | | | | Pattern - Shape and Dimensions | | Pattern - Shape and | | | | (Second Revision) | | Dimensions | | | | | | (First Revision) | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 2 | IS 8334: 2025 | 14 January 2025 | IS 8334-1977 | 14 July 2025 | | | Rongeur, Cranial, Dahlgren's | | Specification for Rongeur, | | | | Pattern Specification | | Cranial, Dahlgren's Pattern | | | | (First Revision) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 3 | IS 18375 (Part 4): 2025 | 14 January 2025 | NA | NA | | | Medical Suction Equipment | | | | | | Part 4 General Requirements | | | | | | (ISO 10079-4: 2021, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 4 | IS 18766 (Part 1): 2025 | 14 January 2025 | NA | NA | | | Biocompatibility Evaluation of | | | | | | Breathing Gas Pathways in | | | | | | Healthcare Applications | | | | | | Part 1 Evaluation and Testing | | | | | | within a Risk Management | | | | | | Process | | | | | | (ISO 18562-1: 2024, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 5 | IS 18951: 2025 | 14 January 2025 | NA | NA | | | Dentistry - Manual | | | | | | Toothbrushes - General | | | | | | Requirements and Test Methods | | | | | | (ISO 20126: 2022, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 6 | IS 18974: 2025 | 14 January 2025 | NA | NA | | | Cardiovascular Implants and | | | | | | Artificial Organs - Cannulae for | | | | | | Extracorporeal Circulation | | | | | | (ISO 18193: 2021, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 7 | IS 18983: 2025 | 14 January 2025 | NA | NA | | | ISO 19213: 2017 | | | | | | Implants for Surgery - Test | | | | | | Methods of Material for Use as a | | | | | | Cortical Bone Model | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 8 | IS 18987: 2025 | 14 January 2025 | NA | NA | | | ISO 22598: 2020 | | | | | | Dentistry - Colour Tabs for | | | | | | Intraoral Tooth Colour | | | | | | Determination | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 9 | IS 18991: 2025 | 14 January 2025 | NA | NA | | | ISO 10394: 2023 | | | | | | Dentistry - Designation System | | | | | | for Supernumerary Teeth | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 10 | IS 18992: 2025 | 14 January 2025 | NA | NA | | | ISO 24395: 2023 | | | | | | Dentistry Classification of | | | | | | Tooth Restorations Preparation | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 11 | IS 18993: 2025 | 14 January 2025 | NA | NA | | | ISO 22683: 2022 | | | | | | Dentistry - Rotational | | | | | | Adaptability Test Between | | | | | | Implant Body and Implant | | | | | | Abutment in Dental Implant | | | | | | Systems | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 12 | IS 18995 (Part 1): 2025 | 14 January 2025 | NA | NA | | | ISO 7787-1: 2016 | | | | | | Dentistry - Laboratory Cutters | | | | | | Part 1 Steel Laboratory Cutters | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 13 | IS 18995 (Part 2): 2025 | 14 January 2025 | NA | NA | | | ISO 7787-2: 2020 | | | | | | Dentistry - Laboratory Cutters | | | | | | Part 2 Carbide Laboratory | | | | | | Cutters | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 14 | IS 18995 (Part 3): 2025 | 14 January 2025 | NA | NA | | | ISO 7787-3: 2017 | | | | | | Dentistry - Laboratory Cutters | | | | | | Part 3 Carbide Cutters for Milling | | | | | | Machines | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 15 | IS 18996 (Part 2): 2025 | 14 January 2025 | NA | NA | | | Dentistry - Extraction Forceps | | | | | | Part 2 Designation | | | | | | (ISO 9173-2: 2010, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 16 | IS 18996 (Part 3): 2025 | 14 January 2025 | NA | NA | | | Dentistry - Extraction Forceps | | | | | | Part 3 Design | | | | | | (ISO 9173-3: 2014, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 17 | IS 18999 (Part 1): 2025 | 14 January 2025 | NA | NA | | | ISO 4865-1: 2023 | | | | | | Dentistry General | | | | | | Requirements of Hand | | | | | | Instruments | | | | | | Part 1 Non-hinged Hand | | | | | | Instruments | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 18 | IS 19044: 2025 | 14 January 2025 | NA | NA | | | Dentistry - Polymer-Based | | | | | | Composite Machinable Blanks | | | | | | (ISO 5139: 2023, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 19 | IS 19046: 2025 | 14 January 2025 | NA | NA | | | Dentistry - Magnetic | | | | | | Attachments | | | | | | (ISO 13017: 2020, MOD) | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ | 20 | IS 19054: 2025 | 14 January 2025 | NA | NA | | | ISO 23298: 2023 | | | | | | Dentistry - Machining | | | | | | Accuracy of Computer-Aided | | | | | | Milling Machines - Methods of | | | | | | Test | | | | +-----+---------------------------------------------------------------------------------+-------------------+---------------------------------------------------------------------------------+------------------+ CHITRA GUPTA, Scientist G & DDG (Hallmarking & Training) [ADVT.-III/4/Exty./930/2024-25] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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