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

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-13032026-270918 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 174] NEW DELHI, THURSDAY, MARCH 12, 2026/PHALGUNA 21, 1947 BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 6th March, 2026 Ref: HQ-PUB013/1/2020-PUB-BIS (1473).—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of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column.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 | No., Year & Title of the Indian Standards Established | Date of | No., Year & Title of the Indian Standards to be Withdrawn, if any | Date of | | No. | | Establishment | | Withdrawal | +=====+====================================================================================================================================+====================+====================================================================================================================================+===================+ | (1) | (2) | (3) | (4) | (5) | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 1 | IS 1984 (Part 7): 2026 | 06 March 2026 | NA | NA | | | ISO 8362-7: 2006 | | | | | | Injection Containers and | | | | | | Accessories Part 7 Injection Caps | | | | | | Made of Aluminium-Plastics | | | | | | Combinations Without | | | | | | Overlapping Plastics Part | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 2 | IS 18294 (Part 1): 2026 | 06 March 2026 | IS/ISO 11137-1: 2006 | 06 September 2026 | | | ISO 11137-1: 2025 | | Sterilization of Health Care | | | | Sterilization of Health Care | | Products — Radiation | | | | Products — Radiation | | Part 1 Requirements for | | | | Part 1 Requirements for the | | Development, Validation and | | | | Development, Validation and | | Routine Control of a | | | | Routine Control of a Sterilization | | Sterilization Process for Medical | | | | Process for Medical Devices | | Devices | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 3 | IS 18344 (Part 1): 2026 | 06 March 2026 | IS/ISO 15883-1: 2006 | 06 September 2026 | | | ISO 15883-1: 2024 | | Washer-Disinfectors | | | | Washer-Disinfectors | | Part 1 General Requirements, | | | | Part 1 General Requirements, | | Terms and Definitions and Tests | | | | Terms and Definitions and Tests | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 4 | IS 18344 (Part 2): 2026 | 06 March 2026 | IS/ISO 15883-2: 2006 | 06 September 2026 | | | ISO 15883-2: 2024 | | Washer-Disinfectors | | | | Washer-Disinfectors | | Part 2 Requirements and Tests | | | | Part 2 Requirements and Tests for | | for Washer-Disinfectors | | | | Washer-Disinfectors Employing | | Employing Thermal Disinfection | | | | Thermal Disinfection for Critical | | for Surgical Instruments, | | | | and Semi-Critical Medical | | Anaesthetic Equipment, Bowls, | | | | Devices | | Dishes, Receivers, Utensils, | | | | | | Glassware, Etc | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 5 | IS 18344 (Part 3): 2026 | 06 March 2026 | IS/ISO 15883-3: 2006 | 06 September 2026 | | | ISO 15883-3: 2024 | | Washer-Disinfectors | | | | Washer-Disinfectors | | Part 3 Requirements and Tests | | | | Part 3 Requirements and Tests for | | for Washer-Disinfectors | | | | Washer-Disinfectors Employing | | Employing Thermal Disinfection | | | | Thermal Disinfection for Human | | for Human Waste Containers | | | | Waste Containers | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 6 | IS 18474 (Part 4): 2026 | 06 March 2026 | IS/ISO 1135-4: 2015 | 06 September 2026 | | | ISO 1135-4: 2025 | | Transfusion Equipment for | | | | Transfusion Equipment for | | Medical Use | | | | Medical Use | | Part 4 Transfusion Sets for | | | | Part 4 Transfusion Sets for Single | | Single Use, Gravity Feed | | | | Use, Gravity Feed | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 7 | IS 18474 (Part 5): 2026 | 06 March 2026 | IS 18474 (Part 5): 2024 | 06 September 2026 | | | ISO 1135-5: 2025 | | ISO 1135-5: 2015 | | | | Transfusion Equipment for | | Transfusion Equipment for | | | | Medical Use | | Medical Use | | | | Part 5 Transfusion Sets for Single | | Part 5 Transfusion Sets for | | | | Use with Pressure Infusion | | Single Use with Pressure | | | | Apparatus | | Infusion Apparatus | | | | (First Revision) | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 8 | IS 18879 (Part 6): 2026 | 06 March 2026 | IS 18879 (Part 6) : 2024 | 06 September 2026 | | | ISO 8536-6: 2025 | | ISO 8536-6: 2016 | | | | Infusion Equipment for Medical | | Infusion Equipment for Medical | | | | Use | | Use | | | | Part 6 Freeze Drying Closures for | | Part 6 Freeze Drying Closures | | | | Infusion Bottles | | for Infusion Bottles | | | | (First Revision) | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 9 | IS 18879 (Part 13): 2026 | 06 March 2026 | IS 18879 (Part 13): 2024 | 06 September 2026 | | | ISO 8536-13: 2024 | | ISO 8536-13: 2016 | | | | Infusion Equipment for Medical | | Infusion Equipment for Medical | | | | Use Part 13 Graduated Flow | | Use | | | | Regulators for Single Use with | | Part 13 Graduated Flow | | | | Fluid Contact (First Revision) | | Regulators for Single Use with | | | | | | Fluid Contact | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 10 | IS 19282 (Part 4): 2026 | 06 March 2026 | NA | NA | | | ISO 11608-4: 2022 | | | | | | Needle-Based Injection Systems | | | | | | for Medical Use Requirements | | | | | | and Test Methods | | | | | | Part 4 Needle-Based Injection | | | | | | Systems Containing Electronics | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 11 | IS 19329 (Part 7): 2026 | 06 March 2026 | NA | NA | | | ISO 11040-7:2024 | | | | | | Prefilled Syringes | | | | | | Part 7 Packaging Systems for | | | | | | Sterilized Subassembled Syringes | | | | | | Ready for Filling | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 12 | IS 19329 (Part 8): 2026 | 06 March 2026 | NA | NA | | | ISO 11040-8:2016 | | | | | | Prefilled Syringes | | | | | | Part 8 Requirements and Test | | | | | | Methods for Finished Prefilled | | | | | | Syringes | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 13 | IS 19611 (Part 1): 2026 | 06 March 2026 | NA | NA | | | ISO 8871-1:2003 | | | | | | Elastomeric Parts for Parenterals | | | | | | and for Devices for | | | | | | Pharmaceutical Use Part 1 | | | | | | Extractables in Aqueous | | | | | | Autoclavates | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 14 | IS 19611 (Part 3): 2026 | 06 March 2026 | NA | NA | | | ISO 8871-3: 2003 | | | | | | +AMD 1: 2018 | | | | | | Elastomeric Parts for Parenterals | | | | | | and for Devices for | | | | | | Pharmaceutical Use Part 3 | | | | | | Determination of Released- | | | | | | Particle Count | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ | 15 | IS 19611 (Part 4): 2026 | 06 March 2026 | NA | NA | | | ISO 8871-4: 2006 | | | | | | Elastomeric Parts for Parenterals | | | | | | and for Devices for | | | | | | Pharmaceutical Use Part 4 | | | | | | Biological Requirements and Test | | | | | | Methods | | | | +-----+------------------------------------------------------------------------------------------------------------------------------------+--------------------+------------------------------------------------------------------------------------------------------------------------------------+-------------------+ CHITRA GUPTA, Scientist G & DDG (Hallmarking and Training) [ADVT.-III/4/Exty./750/2025-26] 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. GORAKHA NATH YADAVA Digitally signed by GORAKHA NATH YADAVA Date: 2026.03.13 15:00:06 +05'30'