BIS - LIMS (Laboratory Information Management System)

TUV Rheinland (India) Pvt. Ltd.

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.

Exclusion

Testing Charges (Excl. Of Taxes)

Facility Type

Effective Date

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

Complete

03 Feb, 2027

-
-

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

Complete

03 Feb, 2027

-
-

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

Complete

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

Complete

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

Complete

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

Complete

03 Feb, 2027

-
-

Bureau of Indian Standards

The National Standards Body of India

TUV Rheinland (India) Pvt. Ltd.

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