The Bureau of Indian Standards (BIS) on May 07, 2024, issued the Date of Establishment and Withdrawal of Indian Standard Particulars related to Medical Electrical Equipment.
The following Indian Standards were Established on April 22, 2024, namely:
• 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)
• 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).
• 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)
The following Indian Standards were Withdrawn on May 22, 2024, namely:
• 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).
• 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
• 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
[Notification No HQ-PUB013/1/2020-PUB-BIS (862)]
