| 1 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 18 (2014) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment |
- |
900000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT
and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
30000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against
hazardous outputs) |
- |
40000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
40000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
50000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
50000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
90000 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
80000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 2 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 84 (2023) |
Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment |
- |
975000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME equipment) |
- |
30000 |
|
- |
| 201.6(Classification of ME equipment and ME systems) |
- |
10000 |
|
- |
| 201.7(ME equipment identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical hazards from ME equipment) |
- |
40000 |
|
- |
| 201.9(Protection against mechanical hazards of ME equipment and ME systems) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation hazards) |
- |
30000 |
|
- |
| 201.11(201.11 Protection against excessive temperatures and other hazards) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
30000 |
|
- |
| 201.13(Hazardous situations and fault conditions for ME equipment) |
- |
28000 |
|
- |
| 201.14(Programmable electrical medical systems (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME equipment) |
- |
30000 |
|
- |
| 201.16(ME systems) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
350000 |
|
- |
| 201.101(Gas connections) |
- |
10000 |
|
- |
| 201.102(Requirements for the VBS and accessories) |
- |
10000 |
|
- |
| 201.103(Spontaneous breathing during loss of power supply) |
- |
10000 |
|
- |
| 201.104(Indication of duration of operation) |
- |
10000 |
|
- |
| 201.105(Functional connection) |
- |
10000 |
|
- |
| 201.106(Connection to a distributed alarm system) |
- |
10000 |
|
- |
| 201.107(Timed ventilatory pause) |
- |
10000 |
|
- |
| 202(Electromagnetic disturbances — Requirements and tests) |
- |
75000 |
|
- |
| 206(Usability) |
- |
60000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
150000 |
|
- |
| 212(Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment) |
- |
30000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 3 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 31 (2021) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 31 External Cardiac Pacemakers with Internal Power Source First Revision |
- |
950000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8.5.5(DEFIBRILLATION-PROOF APPLIED PARTS) |
- |
80000 |
|
- |
| 201.8.7.3(Allowable values) |
- |
10000 |
|
- |
| 201.8.7.4(Measurements) |
- |
10000 |
|
- |
| 201.8.101(High-frequency surgical ME EQUIPMENT protection) |
- |
50000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMEN) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
300000 |
|
- |
| 202(ELECTROMAGNETIC DISTURBANCES – Requirements and tests) |
- |
300000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 4 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 39 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment |
- |
975000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
35000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
100000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
300000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
| 208(General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS) |
- |
100000 |
|
- |
| 211(Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT) |
- |
100000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 5 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 16 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment |
- |
950000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
0 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
0 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
0 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
0 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT
and ME SYSTEMS) |
- |
0 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
0 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
0 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against
hazardous outputs) |
- |
0 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
0 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
0 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
0 |
|
- |
| 201.16(ME SYSTEMS) |
- |
0 |
|
- |
| 201.17(ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
0 |
|
- |
| 208(General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
) |
- |
0 |
|
- |
| 209(Requirements for environmentally conscious design) |
- |
0 |
|
- |
| 210(Requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS) |
- |
0 |
|
- |
| 211(Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT) |
- |
0 |
|
- |
|
05 Apr, 2027 |
-
- |
| 6 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| 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 |
- |
950000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(ELECTROMAGNETIC DISTURBANCES – Requirements and tests) |
- |
350000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
100000 |
|
- |
| Annex BB(ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT) |
- |
350000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 7 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : PART 2 : SEC 4 (2018) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision) |
- |
875000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification Of ME equipment and ME systems) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
50000 |
|
- |
| 201.9(Protection against MECAHNICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
30000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
30000 |
|
- |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
350000 |
|
- |
| 202(Electromagnetic compatibility-Requirement and tests) |
- |
350000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 8 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 21 (2023) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision |
- |
720000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 9 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 46 (2020) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables |
- |
580000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing OPERATING TABLES) |
- |
30000 |
|
- |
| 201.6(Classification of OPERATING TABLES and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(OPERATING TABLES identification, marking and document) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from OPERATING TABLES) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of OPERATING TABLES and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for OPERATING TABLES) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of OPERATING TABLES) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of OPERATING TABLES and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
| 203(Radiation protection in diagnostic X-ray equipment) |
- |
50000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 10 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 41 (2020) |
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis |
- |
340000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT Identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 11 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 34 (2019) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment |
- |
580000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6.2(Protection against electric shock) |
- |
10000 |
|
- |
| 201.6.6(Mode of operation) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
150000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS) |
- |
100000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 12 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 27 (2018) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment |
- |
340000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(Me Systems) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
150000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems) |
- |
100000 |
|
- |
| 202.6(ELECTROMAGNETIC COMPATIBILITY) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 13 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 52 (2020) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds |
- |
580000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
30000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 14 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 20 (2023) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 20 Infant Transport Incubators First Revision |
- |
800000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
| 212(* Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS intended for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT) |
- |
80000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 15 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 19 (2023) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision |
- |
720000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
35000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 16 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 50 (2022) |
Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment |
- |
900000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and document) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
35000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
25000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
25000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
10000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
150000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 17 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 25 (2018) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs |
- |
774500 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(Power and Current) |
- |
10000 |
|
- |
| 201.5(Temperature, Humidity, Dimensions, Force) |
- |
10000 |
|
- |
| 201.7.4.101(Qualitative) |
- |
0 |
|
- |
| 201.8(Current, Voltage, Energy, Dimensions, Impedance) |
- |
25000 |
|
- |
| 201.8.5.5.1(Voltage, Time) |
- |
0 |
|
- |
| 201.8.5.5.2(Energy) |
- |
0 |
|
- |
| 201.9(Mechanical dimensions, strength , torque, force) |
- |
20000 |
|
- |
| 201.11(Temperature) |
- |
15000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.12.1.101.1(Automated measurements on ECGS) |
- |
0 |
|
- |
| 201.12.1.101.2(Requirements for amplitude measurements) |
- |
0 |
|
- |
| 201.12.1.101.3(Requirements for interval measurements) |
- |
0 |
|
- |
| 201.12.1.101.3.2() |
- |
0 |
|
- |
| 201.12.4(Protection against hazardous output) |
- |
25000 |
|
- |
| 201.12.4.101(Indication of inoperable ELECTROCARDIOGRAPH) |
- |
0 |
|
- |
| 201.12.4.102(ECG signals) |
- |
0 |
|
- |
| 201.12.4.102.1(ECG signals) |
- |
0 |
|
- |
| 201.12.4.102.2(Minimum required configuration) |
- |
0 |
|
- |
| 201.12.4.102.3(ECG signals) |
- |
0 |
|
- |
| 201.12.4.102.3.1(General) |
- |
0 |
|
- |
| 201.12.4.102.3.2(Goldberger and Wilson LEADS) |
- |
0 |
|
- |
| 201.12.4.102.4(Recovery time) |
- |
0 |
|
- |
| 201.12.4.103(Input impedance) |
- |
0 |
|
- |
| 201.12.4.104(Required GAINS) |
- |
0 |
|
- |
| 201.12.4.105.2(Overload tolerance) |
- |
0 |
|
- |
| 201.12.4.105.3(FILTERS (including line frequency interference FILTERS)) |
- |
0 |
|
- |
| 201.12.4.106.1(Noise level) |
- |
0 |
|
- |
| 201.12.4.106.2(CHANNEL crosstalk) |
- |
0 |
|
- |
| 201.12.4.107.1.1.1(High Frequency Response) |
- |
0 |
|
- |
| 201.12.4.107.1.1.2(Low frequency (impulse) response) |
- |
0 |
|
- |
| 201.12.4.107.1.2(Test with calibration ECG) |
- |
0 |
|
- |
| 201.12.4.107.2(Linearity and Dynamic range) |
- |
0 |
|
- |
| 201.12.4.107.3(Sampling and amplitude quantisation during data acquisition) |
- |
0 |
|
- |
| 201.12.4.108(Printing, electronic storage and transmission) |
- |
0 |
|
- |
| 201.12.4.108.1(Record identification) |
- |
0 |
|
- |
| 201.12.4.108.2(PATIENT identification) |
- |
0 |
|
- |
| 201.12.4.108.3.1(Time and event markers) |
- |
0 |
|
- |
| 201.12.4.108.3.2(Recording speed) |
- |
0 |
|
- |
| 201.12.4.108.3.3(Time and amplitude ruling) |
- |
0 |
|
- |
| 201.12.4.109(Use with cardiac pacemakers) |
- |
0 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
25000 |
|
- |
| 201.15(Mechanical strength, Temperature, current) |
- |
25000 |
|
- |
| 15.3(Force, Dimensions, Temperature) |
- |
0 |
|
- |
| 201.16(Leakage currents , dielectirc strength) |
- |
25000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
15000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
15000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147000 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
147500 |
|
- |
| 201.12.1.101.3.1(* Requirements for absolute interval and wave duration measurements) |
- |
0 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
0 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
15000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
0 |
|
- |
| 202.6.1(EMISSIONS) |
- |
25000 |
|
- |
| 202.6.2.2(ELECTROSTATIC DISCHARGE (ESD)) |
- |
25000 |
|
- |
| 202.6.2.3(Radiated RF electromagnetic fields) |
- |
25000 |
|
- |
| 202.6.2.4(Electrical fast transients and bursts) |
- |
25000 |
|
- |
| 202.6.2.6(Conducted disturbances, induced by RF fields) |
- |
25000 |
|
- |
| 202.6.2.101(Electrosurgery interference) |
- |
0 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
147000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147500 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
20000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
20000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
5000 |
|
- |
| 201.4(General requirements) |
- |
0 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
0 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
0 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
20000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
20000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
0 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 10.11.2025 |
| 18 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 13 (2024) |
Medical Electrical Equipment: Part 2 Particular Requirements for the Basic Safety and Essential Performance: Sec 13 Anaesthetic Workstation (First Revision) |
- |
295000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
147500 |
|
- |
| 202(Electromagnetic disturbances — Requirements and tests) |
- |
147500 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 26.11.2025
Exclusion: only for 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) and 202 (Electromagnetic compatibility – Requirements and tests) |
| 19 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 37 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment |
- |
315000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.17(ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) |
- |
157500 |
|
- |
| 202.6(ELECTROMAGNETIC COMPATIBILITY – Requirements and test) |
- |
157500 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 26.11.2025
Only for 201.17 (ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) and 202.6 (ELECTROMAGNETIC COMPATIBILITY – Requirements and test) |
| 20 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| 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 |
- |
295000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| Cl-201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147500 |
|
- |
| Cl-202(Electromagnetic disturbances – Requirements and tests) |
- |
147500 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 07.11.2025
only for 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) and 202 (Electromagnetic compatibility – Requirements and tests) |
| 21 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 12 (2023) |
Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators (First Revision) |
- |
295000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
147500 |
|
- |
| 202(Electromagnetic disturbances — Requirements and tests) |
- |
147500 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 07.11.2025
only for 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) and 202 (Electromagnetic compatibility – Requirements and tests) |
| 22 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 16 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment |
- |
315000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.17(ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) |
- |
157000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
157000 |
|
- |
| 201.17(ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) |
- |
157000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
157000 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 07.11.2025
only for 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) and 202 (Electromagnetic compatibility – Requirements and tests) |
| 23 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : PART 2 : SEC 24 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision) |
- |
295000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147500 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
147500 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147500 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
147500 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
147500 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
147500 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f 06-11-2025, only for 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) and 202 (Electromagnetic compatibility – Requirements and tests) |
| 24 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 12 (2023) |
Medical Electrical Equipment Part 2 Particular requirements for basic safety and essential performance Section 12 Critical care ventilators (First Revision) |
- |
975000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME equipment) |
- |
30000 |
|
- |
| 201.6(Classification of ME equipment and ME systems) |
- |
10000 |
|
- |
| 201.7(ME equipment identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical hazards from ME equipment) |
- |
40000 |
|
- |
| 201.9(Protection against mechanical hazards of ME equipment and ME systems) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation hazards) |
- |
30000 |
|
- |
| 201.11(Protection against excessive temperatures and other hazards) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
30000 |
|
- |
| 201.13(Hazardous situations and fault conditions for ME equipment) |
- |
28000 |
|
- |
| 201.14(Programmable electrical medical systems (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME equipment) |
- |
30000 |
|
- |
| 201.16(ME systems) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
350000 |
|
- |
| 201.101(Gas connections) |
- |
15000 |
|
- |
| 201.102(Requirements for the VBS and accessories) |
- |
10000 |
|
- |
| 201.103(Spontaneous breathing during loss of power supply) |
- |
10000 |
|
- |
| 201.104(Indication of duration of operation) |
- |
10000 |
|
- |
| 201.105(Functional connection) |
- |
10000 |
|
- |
| 201.106(Display loops) |
- |
10000 |
|
- |
| 201.107(Timed ventilatory pause) |
- |
10000 |
|
- |
| 202(Electromagnetic disturbances — Requirements and tests) |
- |
350000 |
|
- |
| 206(Usability) |
- |
60000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 25 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 13 (2024) |
Medical Electrical Equipment: Part 2 Particular Requirements for the Basic Safety and Essential Performance: Sec 13 Anaesthetic Workstation (First Revision) |
- |
950000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing ME equipment) |
- |
30000 |
|
- |
| 201.6(Classification of ME equipment or ME systems) |
- |
10000 |
|
- |
| 201.7(ME equipment identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical hazards from ME equipment) |
- |
40000 |
|
- |
| 201.9(Protection against mechanical hazards of ME equipment and ME systems) |
- |
25000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation hazards) |
- |
35000 |
|
- |
| 201.11(Protection against excessive temperatures and other hazards) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
30000 |
|
- |
| 201.13(Hazardous situations and fault conditions) |
- |
28000 |
|
- |
| 201.14(Programmable electrical medical systems (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME equipment) |
- |
30000 |
|
- |
| 201.16(ME systems) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
350000 |
|
- |
| 201.101(Additional requirements for anaesthetic gas delivery systems) |
- |
15000 |
|
- |
| 201.102(Additional requirements for an anaesthetic breathing system) |
- |
10000 |
|
- |
| 201.103(Additional requirements for an AGSS) |
- |
10000 |
|
- |
| 201.104(Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems) |
- |
10000 |
|
- |
| 201.105(Additional requirements for an anaesthetic ventilator) |
- |
10000 |
|
- |
| 201.106(Display of pressure-volume loops) |
- |
10000 |
|
- |
| 201.107(Clinical evaluation) |
- |
10000 |
|
- |
| 202(Electromagnetic disturbances — Requirements and tests) |
- |
350000 |
|
- |
| 206(Usability) |
- |
60000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
150000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 26 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 2 : Sec 37 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment |
- |
950000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
0 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
0 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
0 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
0 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
0 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
0 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
0 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
0 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
0 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
0 |
|
- |
| 201.16(ME SYSTEMS) |
- |
0 |
|
- |
| 201.17(ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 202.6(ELECTROMAGNETIC COMPATIBILITY – Requirements and test) |
- |
0 |
|
- |
|
05 Apr, 2027 |
-
- |
| 27 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : PART 2 : SEC 24 (2019) |
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision) |
- |
875000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
25000 |
|
- |
| 201.5(General requirements for testing of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEM) |
- |
10000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
10000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
25000 |
|
- |
| 201.1(Protection against unwanted and excessive radiation HAZARDS) |
- |
25000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
35000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
35000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
30000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
25000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
30000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
20000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
350000 |
|
- |
| 202(Electromagnetic compatibility – Requirements and tests) |
- |
350000 |
|
- |
| 206(Usability) |
- |
100000 |
|
- |
| 208(General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems) |
- |
100000 |
|
- |
|
05 Apr, 2027 |
-
- |
| 28 |
Conformity Testing Labs Pvt. Ltd. Unit 2 (A33)
| 8139626
| IS 13450 : Part 1 : SEC 2 (2018) |
Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) |
- |
395000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 4.1(RISK MANAGEMENT PROCESS for ME EQUIPMENT and ME SYSTEMS) |
- |
10000 |
|
- |
| 4.2(Non-ME EQUIPMENT used in an ME SYSTEM) |
- |
10000 |
|
- |
| 4.3(General test conditions) |
- |
10000 |
|
- |
| 5(ME EQUIPMENT and ME SYSTEMS identification, marking and documents) |
- |
10000 |
|
- |
| 6(Documentation of the tests) |
- |
10000 |
|
- |
| 7.1(Protection of radio services and other equipment) |
- |
10000 |
|
- |
| 7.2(Protection of the PUBLIC MAINS NETWORK) |
- |
10000 |
|
- |
| 8.1(General) |
- |
10000 |
|
- |
| 8.2(PATIENT physiological simulation) |
- |
10000 |
|
- |
| 8.3(Termination of PATIENT-COUPLED parts) |
- |
10000 |
|
- |
| 8.4(HAND-HELD ME EQUIPMENT and parts intended to be HAND-HELD) |
- |
10000 |
|
- |
| 8.5(Subsystems) |
- |
10000 |
|
- |
| 8.6(PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS) |
- |
10000 |
|
- |
| 8.7(Operating modes) |
- |
10000 |
|
- |
| 8.8(Non-ME EQUIPMENT) |
- |
10000 |
|
- |
| 8.9(IMMUNITY TEST LEVELS) |
- |
10000 |
|
- |
| 8.10(IMMUNITY to proximity fields from RF wireless communications equipment) |
- |
10000 |
|
- |
| 9(Test report) |
- |
10000 |
|
- |
| Table 4(ELECTROSTATIC DISCHARGE) |
- |
50000 |
|
- |
| Table 4(RATED power frequency magnetic fields d)e)) |
- |
60000 |
|
- |
| Table 5(Electrical fast transients / bursts) |
- |
50000 |
|
- |
| Table 5(Surges line-to-line) |
- |
70000 |
|
- |
| Table 5(Surges line-to-ground) |
- |
70000 |
|
- |
| Table 5(Conducted disturbances induced by RF fields) |
- |
100000 |
|
- |
| Table 5(Voltage dips) |
- |
40000 |
|
- |
| Table 6(Electrical fast transients / bursts) |
- |
50000 |
|
- |
| Table 6(Surges line-to-line) |
- |
70000 |
|
- |
| Table 6(Surges line-to-ground) |
- |
70000 |
|
- |
| Table 6(Conducted disturbances induced by RF fields) |
- |
100000 |
|
- |
| Table 7(ELECTROSTATIC DISCHARGE) |
- |
50000 |
|
- |
| Table 7(Conducted disturbances induced by RF fields) |
- |
100000 |
|
- |
| Table 8(ELECTROSTATIC DISCHARGE) |
- |
50000 |
|
- |
| Table 8(Electrical fast transients / bursts) |
- |
50000 |
|
- |
| Table 8(Surges line-to-ground) |
- |
70000 |
|
- |
| Table 8(Conducted disturbances induced by RF fields) |
- |
100000 |
|
- |
| Table 5(Voltage interruptions) |
- |
40000 |
|
- |
|
05 Apr, 2027 |
-
Included w.e.f. 14.10.2025
Exclusion: "Table 4 (Radiated RF EM fields)
Table 4 (Proximity fields from RF wireless communications equipment)
Table 6 (Electrical transient conduction along supply lines)" |
| 29 |
Astute Labs Pvt Ltd, Pune
| 7174321
| IS 13450 : Part 2 : Sec 21 (2023) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision |
- |
700000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
50000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
50000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
50000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
50000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
60000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
60000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
50000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
50000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
80000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
50000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
50000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
50000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
50000 |
|
- |
|
05 Nov, 2026 |
-
"1 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) Electromagnetic compatibility of ME EQUIPMENTand ME SYSTEMS We don't have all EMI/EMCtesting facility
2 202 (Electromagnetic disturbances – Requirements and tests) Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS We don't have all EMI/EMCtesting facility" |
| 30 |
AA Electro Magnetic Laboratory Pvt Ltd, Gurugram
| 8165826
| IS 13450 : Part 2 : Sec 21 (2023) |
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision |
- |
1400000 View breakup
-
| Clause No. |
Exclusion |
Testing Charges (Excl. Of Taxes) |
Effective Date |
Remark |
| 201.4(General requirements) |
- |
32000 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
40000 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
33000 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
15000 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
100000 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
45000 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
32000 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
45000 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
17000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
20000 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
22000 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
24000 |
|
- |
| 201.16(ME SYSTEMS) |
- |
30000 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
450000 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
495000 |
|
- |
| 201.4(General requirements) |
- |
0 |
|
- |
| 201.5(General requirements for testing ME EQUIPMENT) |
- |
0 |
|
- |
| 201.6(Classification of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.7(ME EQUIPMENT identification, marking and documents) |
- |
0 |
|
- |
| 201.8(Protection against electrical HAZARDS from ME EQUIPMENT) |
- |
0 |
|
- |
| 201.9(Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 201.10(Protection against unwanted and excessive radiation HAZARDS) |
- |
0 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
0 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
0 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT) |
- |
0 |
|
- |
| 201.14(PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)) |
- |
0 |
|
- |
| 201.15(Construction of ME EQUIPMENT) |
- |
0 |
|
- |
| 201.16(ME SYSTEMS) |
- |
0 |
|
- |
| 201.17(Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS) |
- |
0 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
0 |
|
- |
|
24 Sep, 2026 |
-
Included w.e.f.10.09.2025 |
