BIS - LIMS (Laboratory Information Management System)

TUV Rheinland (India) Pvt. Ltd., Visakhapatnam

Survey No. 480/2, AMTZ Campus, Nadupuru Village, Pedagantyada Mandal, Pragadi Maidan,, visakhapatnam, Visakhapatanam, Andhra Pradesh, 530031

9620288835 Nagendra.Hebbar@ind.tuv.com

Scope List

Reset

6 Results

S.No.

Indian Standard No.

Product

Grade / Type / Size / Designation etc.

Testing Charges (Excl. Of Taxes)

Validity Date

Remark

IS/ISO 80601 : Part 2 : Sec 61 (2017)

Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

531000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
201.4(Power and Current)	-	20000	10% Discount for BIS samples
201.5(Temperature, Humidity, Dimensions, Force)	-	10000	10% Discount for BIS samples
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	5000	10% Discount for BIS samples
201.7(Legibility & Durability of markings)	-	5000	10% Discount for BIS samples
201.7.2.9.101(Ingress Protection)	-	30000	10% Discount for BIS samples
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	100000	10% Discount for BIS samples
201.8.3.101(Current, Voltage, Energy, Dimensions, Impedance)	-	20000	10% Discount for BIS samples
201.8.5.5.1(Voltage, Time)	-	20000	10% Discount for BIS samples
201.8.5.5.2(Energy)	-	10000	10% Discount for BIS samples
201.9(Mechanical dimensions, strength , torque, force)	-	30000	10% Discount for BIS samples
201.11(Temperature)	-	18000	10% Discount for BIS samples
201.11.6.5.101(Temperature)	-	18000	10% Discount for BIS samples
201.11.8.101(Power)	-	18000	10% Discount for BIS samples
201.11.8.101.1(Power)	-	18000	10% Discount for BIS samples
201.11.8.101.2(Temperature)	-	18000	10% Discount for BIS samples
201.11.8.101.3(Temperature)	-	18000	10% Discount for BIS samples
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	5000	10% Discount for BIS samples
201.12.1.101, 201.12.1.101.1(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.12.1.101.2(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.12.1.101.3(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.12.1.101.4(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.12.1.102(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.12.1.103(SpO2 ACCURACY)	-	5000	10% Discount for BIS samples
201.13(Temperature, Voltage, Current)	-	15000	10% Discount for BIS samples
201.13.101(Temperature, Voltage, Current)	-	15000	10% Discount for BIS samples
201.15(Mechanical strength, Temperature, current)	-	26000	10% Discount for BIS samples
201.15.3.5.101.1(Shock and vibration)	-	26000	10% Discount for BIS samples
201.15.101(Shock and vibration)	-	26000	10% Discount for BIS samples
201.16(Leakage currents , dielectirc strength)	-	10000	10% Discount for BIS samples
208(Alarm system verification)	-	10000	10% Discount for BIS samples
208.6.1.2.101(Alarm system verification)	-	10000	10% Discount for BIS samples
201.4(Power and Current)	-	0	This is duplicate entry,
201.5(Temperature, Humidity, Dimensions, Force)	-	0	This is duplicate entry,
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	0	This is duplicate entry,
201.7(Legibility & Durability of markings)	-	0	This is duplicate entry,
201.7.2.9.101(Ingress Protection)	-	0	This is duplicate entry,
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	This is duplicate entry,
201.8.3.101(Current, Voltage, Energy, Dimensions, Impedance)	-	0	This is duplicate entry,
201.8.5.5.1(Voltage, Time)	-	0	This is duplicate entry,
201.8.5.5.2(Energy)	-	0	This is duplicate entry,
201.9(Mechanical dimensions, strength , torque, force)	-	0	This is duplicate entry,
201.11(Temperature)	-	0	This is duplicate entry,
201.11.6.5.101(Temperature)	-	0	This is duplicate entry,
201.11.8.101(Power)	-	0	This is duplicate entry,
201.11.8.101.1(Power)	-	0	This is duplicate entry,
201.11.8.101.2(Temperature)	-	0	This is duplicate entry,
201.11.8.101.3(Temperature)	-	0	This is duplicate entry,
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	This is duplicate entry,
201.12.1.101, 201.12.1.101.1(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.12.1.101.2(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.12.1.101.3(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.12.1.101.4(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.12.1.102(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.12.1.103(SpO2 ACCURACY)	-	0	This is duplicate entry,
201.13(Temperature, Voltage, Current)	-	0	This is duplicate entry,
201.13.101(Temperature, Voltage, Current)	-	0	This is duplicate entry,
201.15(Mechanical strength, Temperature, current)	-	0	This is duplicate entry,
201.15.3.5.101.1(Shock and vibration)	-	0	This is duplicate entry,
201.15.101(Shock and vibration)	-	0	This is duplicate entry,
201.16(Leakage currents , dielectirc strength)	-	0	This is duplicate entry,
208(Alarm system verification)	-	0	This is duplicate entry,
208.6.1.2.101(Alarm system verification)	-	0	This is duplicate entry,
201.4(Power and Current)	-	0	Duplicate
201.5(Temperature, Humidity, Dimensions, Force)	-	0	Duplicate
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	0	Duplicate
201.7(Legibility & Durability of markings)	-	0	Duplicate
201.7.2.9.101(Ingress Protection)	-	0	Duplicate
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate
201.8.3.101(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate
201.8.5.5.1(Voltage, Time)	-	0	Duplicate
201.8.5.5.2(Energy)	-	0	Duplicate
201.9(Mechanical dimensions, strength , torque, force)	-	0	Duplicate
201.11(Temperature)	-	0	Duplicate
201.11.6.5.101(Temperature)	-	0	Duplicate
201.11.8.101(Power)	-	0	Duplicate
201.11.8.101.1(Power)	-	0	Duplicate
201.11.8.101.2(Temperature)	-	0	Duplicate
201.11.8.101.3(Temperature)	-	0	Duplicate
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	Duplicate
201.12.1.101, 201.12.1.101.1(SpO2 ACCURACY)	-	0	Duplicate
201.12.1.101.2(SpO2 ACCURACY)	-	0	Duplicate
201.12.1.101.3(SpO2 ACCURACY)	-	0	Duplicate
201.12.1.101.4(SpO2 ACCURACY)	-	0	Duplicate
201.12.1.102(SpO2 ACCURACY)	-	0	Duplicate
201.12.1.103(SpO2 ACCURACY)	-	0	Duplicate
201.13(Temperature, Voltage, Current)	-	0	Duplicate
201.13.101(Temperature, Voltage, Current)	-	0	Duplicate
201.15(Mechanical strength, Temperature, current)	-	0	Duplicate
201.15.3.5.101.1(Shock and vibration)	-	0	Duplicate
201.15.101(Shock and vibration)	-	0	Duplicate
201.16(Leakage currents , dielectirc strength)	-	0	Duplicate
208(Alarm system verification)	-	0	Duplicate
208.6.1.2.101(Alarm system verification)	-	0	Duplicate
201.4(Power and Current)	-	0	Duplicate Entry
201.5(Temperature, Humidity, Dimensions, Force)	-	0	Duplicate Entry
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	0	Duplicate Entry
201.7(Legibility & Durability of markings)	-	0	Duplicate Entry
201.7.2.9.101(Ingress Protection)	-	0	Duplicate Entry
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate Entry
201.8.3.101(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate Entry
201.8.5.5.1(Voltage, Time)	-	0	Duplicate Entry
201.8.5.5.2(Energy)	-	0	Duplicate Entry
201.9(Mechanical dimensions, strength , torque, force)	-	0	Duplicate Entry
201.11(Temperature)	-	0	Duplicate Entry
201.11.6.5.101(Temperature)	-	0	Duplicate Entry
201.11.8.101(Power)	-	0	Duplicate Entry
201.11.8.101.1(Power)	-	0	Duplicate Entry
201.11.8.101.2(Temperature)	-	0	Duplicate Entry
201.11.8.101.3(Temperature)	-	0	Duplicate Entry
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	Duplicate Entry
201.12.1.101, 201.12.1.101.1(SpO2 ACCURACY)	-	0	Duplicate Entry
201.12.1.101.2(SpO2 ACCURACY)	-	0	Duplicate Entry
201.12.1.101.3(SpO2 ACCURACY)	-	0	Duplicate Entry
201.12.1.101.4(SpO2 ACCURACY)	-	0	Duplicate Entry
201.12.1.102(SpO2 ACCURACY)	-	0	Duplicate Entry
201.12.1.103(SpO2 ACCURACY)	-	0	Duplicate Entry
201.13(Temperature, Voltage, Current)	-	0	Duplicate Entry
201.13.101(Temperature, Voltage, Current)	-	0	Duplicate Entry
201.15(Mechanical strength, Temperature, current)	-	0	Duplicate Entry
201.15.3.5.101.1(Shock and vibration)	-	0	Duplicate Entry
201.15.101(Shock and vibration)	-	0	Duplicate Entry
201.16(Leakage currents , dielectirc strength)	-	0	Duplicate Entry
208(Alarm system verification)	-	0	Duplicate Entry
208.6.1.2.101(Alarm system verification)	-	0	Duplicate Entry
201.10(Protection against unwanted and excessive radiation HAZARDS)	-	0	-
201.12.1.104(Pulse rate ACCURACY)	-	0	-
201.12.4(Protection against hazardous output)	-	0	-
211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)	-	0	-
212(Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment)	-	0	-
201.101(PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS)	-	0	-
201.102(Saturation pulse INFORMATION SIGNAL)	-	0	-
201.103(FUNCTIONAL CONNECTION)	-	0	Duplicate Entry
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0.01	Duplicate Entry
201.8.5.5.1(Voltage, Time)	-	0.01	Duplicate Entry
201.11.6.5.101(Temperature)	-	0.01	Duplicate Entry
201.10(Protection against unwanted and excessive radiation HAZARDS)	-	0	Excluded
201.12.1.104(Pulse rate ACCURACY)	-	0	Duplicate Entry
201.12.4(Protection against hazardous output)	-	0	Duplicate Entry
211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)	-	0	Duplicate Entry
212(Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment)	-	0	Duplicate Entry
201.101(PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS)	-	0	Duplicate Entry
201.102(Saturation pulse INFORMATION SIGNAL)	-	0	Duplicate Entry
201.103(FUNCTIONAL CONNECTION)	-	0	Duplicate Entry

03 Feb, 2027

-
Included w.e.f. 25.08.2023 Exclusion: Cl. 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS), Cl. 202 (Electromagnetic disturbances – Requirements and tests), Cl. 201.10 (Protection against unwanted and excessive radiation HAZARDS)

IS 13450 : Part 2 : Sec 25 (2018)

Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs

610000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
201.4(Power and Current)	-	10000	10% Discount for BIS samples
201.5(Temperature, Humidity, Dimensions, Force)	-	15000	10% Discount for BIS samples
201.7.4.101(Qualitative)	-	15000	10% Discount for BIS samples
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	10000	10% Discount for BIS samples
201.8.5.5.1(Voltage, Time)	-	15000	10% Discount for BIS samples
201.8.5.5.2(Energy)	-	15000	10% Discount for BIS samples
201.9(Mechanical dimensions, strength , torque, force)	-	30000	10% Discount for BIS samples
201.11(Temperature)	-	40000	10% Discount for BIS samples
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	5000	10% Discount for BIS samples
201.12.1.101.1(Automated measurements on ECGS)	-	10000	10% Discount for BIS samples
201.12.1.101.2(Requirements for amplitude measurements)	-	10000	10% Discount for BIS samples
201.12.1.101.3(Requirements for interval measurements)	-	10000	10% Discount for BIS samples
201.12.1.101.3.1(* Requirements for absolute interval and wave duration measurements)	-	10000	10% Discount for BIS samples
201.12.1.101.3.2()	-	10000	10% Discount for BIS samples
201.12.4(Protection against hazardous output)	-	10000	10% Discount for BIS samples
201.12.4.101(Indication of inoperable ELECTROCARDIOGRAPH)	-	10000	10% Discount for BIS samples
201.12.4.102(ECG signals)	-	10000	10% Discount for BIS samples
201.12.4.102.1(ECG signals)	-	10000	10% Discount for BIS samples
201.12.4.102.2(Minimum required configuration)	-	10000	10% Discount for BIS samples
201.12.4.102.3(ECG signals)	-	10000	10% Discount for BIS samples
201.12.4.102.3.1(General)	-	10000	10% Discount for BIS samples
201.12.4.102.3.2(Goldberger and Wilson LEADS)	-	10000	10% Discount for BIS samples
201.12.4.102.4(Recovery time)	-	10000	10% Discount for BIS samples
201.12.4.103(Input impedance)	-	10000	10% Discount for BIS samples
201.12.4.104(Required GAINS)	-	5000	10% Discount for BIS samples
201.12.4.105.2(Overload tolerance)	-	20000	10% Discount for BIS samples
201.12.4.105.3(FILTERS (including line frequency interference FILTERS))	-	10000	10% Discount for BIS samples
201.12.4.106.1(Noise level)	-	10000	10% Discount for BIS samples
201.12.4.106.2(CHANNEL crosstalk)	-	10000	10% Discount for BIS samples
201.12.4.107.1.1.1(High Frequency Response)	-	10000	10% Discount for BIS samples
201.12.4.107.1.1.2(Low frequency (impulse) response)	-	10000	10% Discount for BIS samples
201.12.4.107.1.2(Test with calibration ECG)	-	10000	10% Discount for BIS samples
201.12.4.107.2(Linearity and Dynamic range)	-	10000	10% Discount for BIS samples
201.12.4.107.3(Sampling and amplitude quantisation during data acquisition)	-	5000	10% Discount for BIS samples
201.12.4.108(Printing, electronic storage and transmission)	-	5000	10% Discount for BIS samples
201.12.4.108.1(Record identification)	-	5000	10% Discount for BIS samples
201.12.4.108.2(PATIENT identification)	-	5000	10% Discount for BIS samples
201.12.4.108.3.1(Time and event markers)	-	10000	10% Discount for BIS samples
201.12.4.108.3.2(Recording speed)	-	10000	10% Discount for BIS samples
201.12.4.108.3.3(Time and amplitude ruling)	-	10000	10% Discount for BIS samples
201.12.4.109(Use with cardiac pacemakers)	-	10000	10% Discount for BIS samples
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	15000	10% Discount for BIS samples
201.15(Mechanical strength, Temperature, current)	-	55000	10% Discount for BIS samples
201.16(Leakage currents , dielectirc strength)	-	20000	10% Discount for BIS samples
201.4(Power and Current)	-	0	Duplicate Entry
201.5(Temperature, Humidity, Dimensions, Force)	-	0	Duplicate Entry
201.7.4.101(Qualitative)	-	0	Duplicate Entry
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate Entry
201.8.5.5.1(Voltage, Time)	-	0	Duplicate Entry
201.8.5.5.2(Energy)	-	0	Duplicate Entry
201.9(Mechanical dimensions, strength , torque, force)	-	0	Duplicate Entry
201.11(Temperature)	-	0	Duplicate Entry
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	Duplicate Entry
201.12.1.101.1(Automated measurements on ECGS)	-	0	Duplicate Entry
201.12.1.101.2(Requirements for amplitude measurements)	-	0	Duplicate Entry
201.12.1.101.3(Requirements for interval measurements)	-	0	Duplicate Entry
201.12.1.101.3.1(* Requirements for absolute interval and wave duration measurements)	-	0	Duplicate Entry
201.12.1.101.3.2()	-	0	Duplicate Entry
201.12.4(Protection against hazardous output)	-	0	Duplicate Entry
201.12.4.101(Indication of inoperable ELECTROCARDIOGRAPH)	-	0	Duplicate Entry
201.12.4.102(ECG signals)	-	0	Duplicate Entry
201.12.4.102.1(ECG signals)	-	0	Duplicate Entry
201.12.4.102.2(Minimum required configuration)	-	0	Duplicate Entry
201.12.4.102.3(ECG signals)	-	0	Duplicate Entry
201.12.4.102.3.1(General)	-	0	Duplicate Entry
201.12.4.102.3.2(Goldberger and Wilson LEADS)	-	0	Duplicate Entry
201.12.4.102.4(Recovery time)	-	0	Duplicate Entry
201.12.4.103(Input impedance)	-	0	Duplicate Entry
201.12.4.104(Required GAINS)	-	0	Duplicate Entry
201.12.4.105.2(Overload tolerance)	-	0	Duplicate Entry
201.12.4.105.3(FILTERS (including line frequency interference FILTERS))	-	0	Duplicate Entry
201.12.4.106.1(Noise level)	-	0	Duplicate Entry
201.12.4.106.2(CHANNEL crosstalk)	-	0	Duplicate Entry
201.12.4.107.1.1.1(High Frequency Response)	-	0	Duplicate Entry
201.12.4.107.1.1.2(Low frequency (impulse) response)	-	0	Duplicate Entry
201.12.4.107.1.2(Test with calibration ECG)	-	0	Duplicate Entry
201.12.4.107.2(Linearity and Dynamic range)	-	0	Duplicate Entry
201.12.4.107.3(Sampling and amplitude quantisation during data acquisition)	-	0	Duplicate Entry
201.12.4.108(Printing, electronic storage and transmission)	-	0	Duplicate Entry
201.12.4.108.1(Record identification)	-	0	Duplicate Entry
201.12.4.108.2(PATIENT identification)	-	0	Duplicate Entry
201.12.4.108.3.1(Time and event markers)	-	0	Duplicate Entry
201.12.4.108.3.2(Recording speed)	-	0	Duplicate Entry
201.12.4.108.3.3(Time and amplitude ruling)	-	0	Duplicate Entry
201.12.4.109(Use with cardiac pacemakers)	-	0	Duplicate Entry
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	0	Duplicate Entry
201.15(Mechanical strength, Temperature, current)	-	0	Duplicate Entry
201.16(Leakage currents , dielectirc strength)	-	0	Duplicate Entry
201.7(ME EQUIPMENT identification, marking and documents)	-	0	Duplicate Entry
201.12.4.107.1.1.2(Low frequency (impulse) response)	-	0.01	Duplicate Entry
201.12.4.108.1(Record identification)	-	0.01	Duplicate Entry
201.12.4.108.3.3(Time and amplitude ruling)	-	0	-
201.7(ME EQUIPMENT identification, marking and documents)	-	0	Duplicate Entry
201.10(Protection against unwanted and excessive radiation HAZARDS)	-	0	Duplicate Entry
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	0	Duplicate Entry
201.4(Power and Current)	-	0.01	Duplicate Entry
201.5(Temperature, Humidity, Dimensions, Force)	-	0.01	Duplicate Entry
201.12.1.101.3(Requirements for interval measurements)	-	0.01	Duplicate Entry
201.12.4(Protection against hazardous output)	-	0.01	Duplicate Entry
201.12.4.102.3.2(Goldberger and Wilson LEADS)	-	0.01	Duplicate Entry
201.12.4.107.2(Linearity and Dynamic range)	-	0.01	Duplicate Entry
201.12.4.107.3(Sampling and amplitude quantisation during data acquisition)	-	0.01	Duplicate Entry
201.6(Classification of ME EQUIPMENT and ME SYSTEMS)	-	0	Duplicate Entry

03 Feb, 2027

-
Included w.e.f. 25.08.2023 Exclusion: Cl. 201.17 (Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS), Cl. 202 (Electromagnetic compatibility – Requirements and tests), Cl. 202.6.1 (EMISSIONS), Cl. 202.6.2.2 (ELECTROSTATIC DISCHARGE (ESD)), Cl. 202.6.2.3 (Radiated RF electromagnetic fields), Cl. 202.6.2.4 (Electrical fast transients and bursts), Cl. 202.6.2.6 (Conducted disturbances, induced by RF fields), Cl. 202.6.2.101 (Electrosurgery interference), Cl. 201.10 (Protection against unwanted and excessive radiation HAZARDS)

IS 17625 : Part 2 : Sec 69 (2021)

Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 69 Oxygen Concentrator Equipment

610000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
201.4(Power and Current)	-	20000	10% Discount for BIS samples
201.5(Temperature, Humidity, Dimensions, Force)	-	120000	10% Discount for BIS samples
201.7.1.2(Legibility of markings)	-	30000	10% Discount for BIS samples
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	115000	10% Discount for BIS samples
201.9(Mechanical dimensions, strength , torque, force)	-	35000	10% Discount for BIS samples
201.9.6.2.1.101(Additional requirements for audible acoustic energy)	-	35000	10% Discount for BIS samples
201.11(Protection against excessive temperatures and other HAZARDS)	-	12000	10% Discount for BIS samples
201.11.1(Maximum temperature during NORMAL USE)	-	12000	10% Discount for BIS samples
"201.11. 1.2.2"(APPLIED PARTS not intended to supply heat to a PATIENT)	-	12000	10% Discount for BIS samples
201.11.2.101(Additional requirements for fire prevention)	-	12000	10% Discount for BIS samples
201.11.6.7(Leakage currents , dielectirc strength)	-	12000	10% Discount for BIS samples
"201.11. 8.101"()	-	12000	10% Discount for BIS samples
201.11.8.101.1(TECHNICAL ALARM CONDITION for power supply failure)	-	12000	10% Discount for BIS samples
201.11.8.101.2(INTERNAL ELECTRICAL POWER SOURCE)	-	12000	10% Discount for BIS samples
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	15000	10% Discount for BIS samples
"201.12. 1"(Legibility of markings)	-	5000	10% Discount for BIS samples
201.12.1.101(Flowrate control)	-	15000	10% Discount for BIS samples
201.12.1.103(Accuracy of concentration)	-	15000	10% Discount for BIS samples
201.12.1.104(Outlet pressure)	-	15000	10% Discount for BIS samples
201.12.4.4.101.2(Indication of start-up period)	-	5000	10% Discount for BIS samples
201.12.4.102(Low oxygen concentration ALARM CONDITION)	-	5000	10% Discount for BIS samples
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	12000	10% Discount for BIS samples
201.13.2.101(Additional specific SINGLE FAULT CONDITIONS)	-	12000	10% Discount for BIS samples
201.15(Mechanical strength, Temperature, current)	-	30000	10% Discount for BIS samples
201.16(Leakage currents , dielectirc strength)	-	10000	10% Discount for BIS samples
201.17(Electromagnetic compatibility)	-	0	Test under exclusion
201.102.3(Fire RISK reduction in ACCESSORIES)	-	10000	10% Discount for BIS samples
211(Temperature, humidity, altitude, IP, Vibration, Mechanical shock)	-	10000	10% Discount for BIS samples
201.4(Power and Current)	-	0	Duplicate
201.5(Temperature, Humidity, Dimensions, Force)	-	0	Duplicate
201.7.1.2(Legibility of markings)	-	0	Duplicate
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate
201.9(Mechanical dimensions, strength , torque, force)	-	0	Duplicate
201.9.6.2.1.101(Additional requirements for audible acoustic energy)	-	0	Duplicate
201.11(Protection against excessive temperatures and other HAZARDS)	-	0	Duplicate
201.11.1(Maximum temperature during NORMAL USE)	-	0	Duplicate
"201.11. 1.2.2"(APPLIED PARTS not intended to supply heat to a PATIENT)	-	0	Duplicate
201.11.2.101(Additional requirements for fire prevention)	-	0	Duplicate
201.11.6.7(Leakage currents , dielectirc strength)	-	0	Duplicate
"201.11. 8.101"()	-	0	Duplicate
201.11.8.101.1(TECHNICAL ALARM CONDITION for power supply failure)	-	0	Duplicate
201.11.8.101.2(INTERNAL ELECTRICAL POWER SOURCE)	-	0	Duplicate
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	Duplicate
"201.12. 1"(Legibility of markings)	-	0	Duplicate
201.12.1.101(Flowrate control)	-	0	Duplicate
201.12.1.103(Accuracy of concentration)	-	0	Duplicate
201.12.1.104(Outlet pressure)	-	0	Duplicate
201.12.4.4.101.2(Indication of start-up period)	-	0	Duplicate
201.12.4.102(Low oxygen concentration ALARM CONDITION)	-	0	Duplicate
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	0	Duplicate
201.13.2.101(Additional specific SINGLE FAULT CONDITIONS)	-	0	Duplicate
201.15(Mechanical strength, Temperature, current)	-	0	Duplicate
201.16(Leakage currents , dielectirc strength)	-	0	Duplicate
201.17(Electromagnetic compatibility)	-	0	Duplicate
201.102.3(Fire RISK reduction in ACCESSORIES)	-	0	Duplicate
211(Temperature, humidity, altitude, IP, Vibration, Mechanical shock)	-	0	Duplicate
201.4(Power and Current)	-	0.01	Duplicate Entry
201.5(Temperature, Humidity, Dimensions, Force)	-	0	Duplicate Entry
201.7.1.2(Legibility of markings)	-	0.01	Duplicate Entry
201.8(Current, Voltage, Energy, Dimensions, Impedance)	-	0	Duplicate Entry
201.9(Mechanical dimensions, strength , torque, force)	-	0	Duplicate Entry
201.9.6.2.1.101(Additional requirements for audible acoustic energy)	-	0	Duplicate Entry
201.11(Protection against excessive temperatures and other HAZARDS)	-	0	Duplicate Entry
201.11.1(Maximum temperature during NORMAL USE)	-	0	Duplicate Entry
"201.11. 1.2.2"(APPLIED PARTS not intended to supply heat to a PATIENT)	-	0	Duplicate Entry
201.11.2.101(Additional requirements for fire prevention)	-	0	Duplicate Entry
201.11.6.7(Leakage currents , dielectirc strength)	-	0	Duplicate Entry
"201.11. 8.101"()	-	0	Duplicate Entry
201.11.8.101.1(TECHNICAL ALARM CONDITION for power supply failure)	-	0	Duplicate Entry
201.11.8.101.2(INTERNAL ELECTRICAL POWER SOURCE)	-	0.01	Duplicate Entry
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0.01	Duplicate Entry
"201.12. 1"(Legibility of markings)	-	0	Duplicate Entry
201.12.1.101(Flowrate control)	-	0	Duplicate Entry
201.12.1.103(Accuracy of concentration)	-	0	Duplicate Entry
201.12.1.104(Outlet pressure)	-	0	Duplicate Entry
201.12.4.4.101.2(Indication of start-up period)	-	0	Duplicate Entry
201.12.4.102(Low oxygen concentration ALARM CONDITION)	-	0	Duplicate Entry
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	0	Duplicate Entry
201.13.2.101(Additional specific SINGLE FAULT CONDITIONS)	-	0	Duplicate Entry
201.15(Mechanical strength, Temperature, current)	-	0	Duplicate Entry
201.16(Leakage currents , dielectirc strength)	-	0	Duplicate Entry
201.17(Electromagnetic compatibility)	-	0	Duplicate Entry
201.102.3(Fire RISK reduction in ACCESSORIES)	-	0	Duplicate Entry
211(Temperature, humidity, altitude, IP, Vibration, Mechanical shock)	-	0	Duplicate Entry
201.7(ME equipment identification, marking and documents)	-	0	Duplicate Entry
201.10(Protection against unwanted and excessive radiaton hazards)	-	0	Excluded
201.11.3.101(Additional requirements for fire enclosures of ME equipment)	-	0	Duplicate Entry
12.11.6.6(Cleaning and disinfection of ME equipment or ME system)	-	0	Duplicate Entry
201.4(Power and Current)	-	0	Duplicate Entry
201.7.1.2(Legibility of markings)	-	0	Duplicate Entry
201.11.8.101.2(INTERNAL ELECTRICAL POWER SOURCE)	-	0	Duplicate Entry
201.12(Accuracy of controls and instruments and protection against hazardous outputs)	-	0	Duplicate Entry
201.7(ME equipment identification, marking and documents)	-	0	Duplicate Entry
201.10(Protection against unwanted and excessive radiaton hazards)	-	0	Duplicate Entry
201.11.3.101(Additional requirements for fire enclosures of ME equipment)	-	0	Duplicate Entry
12.11.6.6(Cleaning and disinfection of ME equipment or ME system)	-	0	Duplicate Entry
201.6(Classification of ME equipment and ME systems)	-	0	Duplicate Entry
201.12.4.103(Filter for the delivered gas)	-	0	Duplicate Entry
201.12.4.4.101.1(Flowrate control)	-	0	Duplicate Entry
201.6(Classification of ME equipment and ME systems)	-	0	Duplicate Entry
201.12.4.103(Filter for the delivered gas)	-	0	Duplicate Entry
201.12.4.4.101.1(Flowrate control)	-	0	Duplicate Entry
201.9.6.2.1.101(Additional requirements for audible acoustic energy)	-	0.01	Duplicate Entry
201.11.6.7(Leakage currents , dielectirc strength)	-	0.01	Duplicate Entry
201.12.1.101(Flowrate control)	-	0.01	Duplicate Entry
201.12.1.103(Accuracy of concentration)	-	0.01	Duplicate Entry
201.12.1.104(Outlet pressure)	-	0.01	Duplicate Entry
201.13(HAZARDOUS SITUATIONS and fault conditions)	-	0.01	Duplicate Entry
12.11.6.6(Cleaning and disinfection of ME equipment or ME system)	-	0.01	Duplicate Entry

03 Feb, 2027

-
-

IS 17334 (2019)

Medical textiles – Surgical gowns and surgical drapes – Specification

75000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
7.1, Table 1 (i.)(Impact penetration)	-	5000	10 % Discount for BIS Sample
7.1 Table 1 (vii.)(bursting strength (dry and wet) (kPa))	-	5000	10 % Discount for BIS Sample
7.1 Table 1 (vi.)(tensile strength (dry and wet) (N))	-	5000	10 % Discount for BIS Sample
7.1 Table 1 (v.)(Particle release)	-	5000	10 % Discount for BIS Sample
7.1 Table 1 (iii.)(Blood resistance)	-	0	Excluded
7.1 Table 1 (ii.)(Hydrostatic resistance (cmwc))	-	5000	10 % Discount for BIS Sample
7.1 Table 1 (xi.)(Biocompatability evaluation Cytotoxicity, Irritation and skin sensitization)	-	25000	10 % Discount for BIS Sample
7.1 Table 1 (xii.)(Moisture vapour transmission rate (Max.))	-	0	excluded
7.1 Table 1 (x.)(Resistance to microbial penetration — Wet (IB))	-	0	Excluded
7.1 Table 1 (ix.)(Resistance to microbial penetration — Dry (CFU))	-	10000	10 % Discount for BIS Sample
7.1 Table 1 (viii.)(Cleanliness–microbial (CFU/100 cm2))	-	15000	10 % Discount for BIS Sample
7.1 Table 1 (iv.)(Viral resistance)	-	0	Excluded

03 Feb, 2027

-
-

IS 16289 (2014)

Medical textiles - Surgical face masks - Specification

Medical Textile - Sugical face mask

22000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
4.1.1(Materials and Construction)	-	2000	10 % Discount for BIS Sample
4.2 Table 1 i)(Bacterial Filtration Efficiency)	-	5000	10 % Discount for BIS Sample
4.2 Table 1 ii)(Differential Pressure)	-	5000	10 % Discount for BIS Sample
4.2 Table 1 iii)(Splash Resistance)	-	5000	10 % Discount for BIS Sample
4.2 Table 1 iv)(Sub-micron particulate filtration efficiency at 0.1 µ)	-	5000	10 % Discount for BIS Sample

03 Feb, 2027

-
-

IS 9473 (2002)

Respiratory protective devices - Filtering half masks to protect against particles - Specification (First Revision)

55000 View breakup
-

Clause No.	Exclusion	Testing Charges (Excl. Of Taxes)	Remark
Cl 5.1(Material)	-	0	Nil
Cl 5.2(Cleaning and Disinfecting)	-	4000	10 % Discount for BIS Sample
Cl 5.3(Practical Performance Test)	-	4000	10 % Discount for BIS Sample
Cl 5.4(Leakage)	-	5000	10 % Discount for BIS Sample
Cl 5.5(Compatibility with Skin)	-	4000	10 % Discount for BIS Sample
Cl 5.6(Flammability)	-	5000	10 % Discount for BIS Sample
Cl 5.7(Carbon Dioxide Content of the Inhalation Air)	-	5000	10 % Discount for BIS Sample
Cl 5.8(Head Harness)	-	4000	10 % Discount for BIS Sample
Cl 5.9(Field of Vision)	-	4000	10 % Discount for BIS Sample
Cl 5.10(Inhalation and Exhalation Valves)	-	5000	10 % Discount for BIS Sample
Cl 5.11(Breathing Resistance)	-	5000	10 % Discount for BIS Sample
Cl 5.12(Clogging (Coal & Dolomite))	-	8000	10 % Discount for BIS Sample
5.13(Demountable Parts, Visual Inspection )	-	2000	10 % Discount for BIS Sample

03 Feb, 2027

-
-

Bureau of Indian Standards

The National Standards Body of India

TUV Rheinland (India) Pvt. Ltd., Visakhapatnam

Survey No. 480/2, AMTZ Campus, Nadupuru Village, Pedagantyada Mandal, Pragadi Maidan,, visakhapatnam, Visakhapatanam, Andhra Pradesh, 530031

9620288835 Nagendra.Hebbar@ind.tuv.com

Scope List