Total Standards : 16
| S.No | IS Number | IS Title | Aspect | Degree of Equivalence (E) |
Date of Pub. (F) |
Document | Action |
|---|---|---|---|---|---|---|---|
| 1 | IS 11789 : 2024 |
Determination of the Maximum Symmetrical Radiation Field of X-Ray Tube Assemblies and X-Ray Source Assemblies for Medical Diagnosis (IEC 60806 : 2022, MOD) (First Revision) | Methods of tests | Modified/Technically Equivalent | 09-04-2024 | ||
| 2 | IS 13450 (Part 1) : 2024 |
Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 3 | 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 (Second Revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 4 | 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 (First Revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 5 | IS 13450 (Part 1/Sec 6) : 2024 |
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 6 Usability (First revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 6 | 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 (First Revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 7 | 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 (First Revision) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 8 | 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 (First Revison) | Others | Modified/Technically Equivalent | 07-05-2024 | ||
| 9 | IS/IEC 61675-1 : 2022 IEC 61675-1:2022 |
Radionuclide Imaging Devices — Characteristics and Test Conditions Part 1 Positron Emission Tomographs (First Revision) | Methods of tests | Identical under single numbering | 04-06-2024 | ||
| 10 | IS/ISO 13450-2-10) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators First revision | Product Specification | Modified/Technically Equivalent | 15-07-2024 | ||
| 11 | IS 13450 (Part 2/Sec 43) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures Second revision | Product Specification | Modified/Technically Equivalent | 09-07-2024 | ||
| 12 | IS 13450 (Part 2/Sec 45) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices Second revision | Product Specification | Modified/Technically Equivalent | 09-07-2024 | ||
| 13 | IS 13450 (Part 2/Sec 54) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 54 X-ray equipment for radiography and radioscopy First revision | Product Specification | Modified/Technically Equivalent | 09-07-2024 | ||
| 14 | IS 13450 (Part 2/Sec 65) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision | Product Specification | Modified/Technically Equivalent | 09-07-2024 | ||
| 15 | IS 13450 (Part 2/Sec 2) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 2 High frequency surgical equipment and high frequency surgical accessories First revision | Product Specification | Modified/Technically Equivalent | 18-07-2024 | ||
| 16 | IS 13450 (Part 2/Sec 3) : 2024 |
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment First revision | Product Specification | Modified/Technically Equivalent | 18-07-2024 |