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

CG-DL-E-08052024-254104 EXTRAORDINARY PART III—Section 4 No. 321] NEW DELHI, TUESDAY, MAY 07, 2024/VISAKHA 17, 1946 2933 GI/2024 (1) BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, 25th April, 2024 Ref:) Ref: HQ-PUB013/1/2020-PUB-BIS (862).— 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of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column.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& Title of the Indian Standards Established | Date of Establishment | No. , Year & Title of the Indian Standards to be Withdrawn, if any | Date of Withdrawal | |---|---|---|---|---| | (1) | (2) | (3) | (4) | (5) | | 1 | IS 13450 (Part 1) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance (IEC 60601-1 : 2020, MOD) (Third Revision) | 22 April 2024 | IS 13450 (Part 1) : 2018 IEC 60601-1 : 2012) (Ed 3.1) Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance (Second Revision) | 22 May 2024 | | 2 | IS 13450 (Part 1/Sec 2) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 2 Electromagnetic Disturbances — Requirements and Tests (IEC 60601-1-2 : 2020, MOD) (Second Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 2) : 2018 IEC 60601-1-2 : 2014 Medical Electrical Equipment Part 1 General Requirements for the Basic Safety and Essential Performance Section 2 Collateral standard: Electromagnetic disturbances — Requirements and tests (First Revision) | 22 May 2024 | | 3 | IS 13450 (Part 1/Sec 3) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 3 Radiation Protection in Diagnostic X-Ray Equipment (IEC 60601-1-3 : 2021, MOD) (First Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 3) : 2014 IEC 60601-1-3 : 2008 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 3 Collateral standard: Radiation Protection in Diagnostic X-Ray equipment | 22 May 2024 | | 4 | IS 13450 (Part 1/Sec 6) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Usability (IEC 60601-1-6 : 2020, MOD) (First Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 6) : 2020 IEC 60601-1-6 : 2013 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability | 22 May 2024 | | 5 | IS 13450 (Part 1/Sec 8) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 8 General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (IEC 60601-1-8 : 2020, MOD) (First Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 8) : 2019 IEC 60601-1-8 : 2012 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 8 Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems | 22 May 2024 | | 6 | IS 13450 (Part 1/Sec 10) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Requirements for the Development of Physiologic Closed- Loop Controllers (IEC 60601-1-10 : 2020, MOD) (First Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 10) : 2019 IEC 60601-1-10 : 2013 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral Standard: Requirements for the Development of Physiologic Closed-Loop Controllers | 22 May 2024 | |---|---|---|---|---| | 7 | IS 13450 (Part 1/Sec 11) : 2024 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (IEC 60601-1-11 : 2020, MOD) (First Revision) | 22 April 2024 | IS 13450 (Part 1/Sec 11) : 2020 IEC 60601-1-11 : 2015 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 11 Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | 22 May 2024 | | 8 | IS 18609 : 2024 ISO 20399 : 2022 Biotechnology — Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products | 22 April 2024 | IS 17647 (Part 1) : 2021 ISO/TS 20399-1 : 2018 Biotechnology — Ancillary Materials Present During the Production of Cellular Therapeutic Products Part 1 General Requirements IS 17647 (Part 2) : 2021 ISO/TS 20399-2 : 2018 Biotechnology — Ancillary Materials Present During the Production of Cellular Therapeutic Products Part 2 Best Practice Guidance for Ancillary Material Suppliers IS 17647 (Part 3) : 2021 ISO/TS 20399-3 : 2018 Biotechnology — Ancillary Materials Present During the Production of Cellular Therapeutic Products Part 3 Best Practice Guidance for Ancillary Material Users | 22 May 2024 | [ADVT.-III/4/Exty./090/2024-25] and Published by the Controller of Publications, Delhi-110054. MANOJ KUMAR VERMA MANOJ KUMAR VERMA Date: 2024.05.08 19:12:37 +05'30'