Programme of work


BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD15 : Electromedical, Diagnostic Imaging and Radiotherapy Equipment


  • Scope : To prepare Standards for: i) Electrical equipment concerning diagnostic, surgical, therapeutic and monitoring equipment for various specialties ; ii) Ionizing radiation imaging and radiotherapy, dentistry, equipment for radiotherapy, nuclear medicine and radiation dosimetry
  • Liaison :
    IEC TC 62 - Medical equipment, software, and systems - Participating (P)
    IEC TC 62 / SC 62 A - Common aspects of medical equipment, software, and systems - Participating (P)
    IEC TC 62 / SC 62 B - Medical imaging equipment, software, and systems - Participating (P)
    IEC TC 62 / SC 62 C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry - Participating (P)
    IEC TC 62 / SC 62 D - Particular medical equipment, software, and systems - Participating (P)

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
IS/ISO/TS 10974 : 2018
ISO TS 10974 : 2018
Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device
-
Identical under single numbering
2.
IS 11393 : 1985
Reviewed In : 2021
Specification for scintillation counters
December, 2021
-
Indigenous
3.
IS 11478 : 2018
IEC/TR 60930 : 2008
Reviewed In : 2023
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems (First Revision)
August, 2023
-
Identical under dual numbering
4.
IS 11753 : 1986
Reviewed In : 2021
Specification for electrical impedance plethysmograph
December, 2021
-
Indigenous
5.
IS 11789 : 2024
Determination of the Maximum Symmetrical Radiation Field of X-Ray Tube Assemblies and X-Ray Source Assemblies for Medical Diagnosis (IEC 60806 : 2022, MOD) (First Revision)
-
Modified/Technically Equivalent
6.
IS 13450 (Part 1) : 2024
Medical electrical equipment Part 1 General requirements for basic safety and essential performance (Third Revision)
-
Modified/Technically Equivalent
7.
IS 13450 (Part 1/Sec 2) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 2 Electromagnetic disturbances Requirements and tests (Second Revision)
-
Modified/Technically Equivalent
8.
IS 13450 (Part 1/Sec 3) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 3 Radiation protection in diagnostic X-ray equipment (First Revision)
-
Modified/Technically Equivalent
9.
IS 13450 (Part 1/Sec 6) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 6 Usability (First revision)
-
Modified/Technically Equivalent
10.
IS 13450 (Part 1/Sec 8) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 8 General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (First Revision)
-
Modified/Technically Equivalent
11.
IS 13450 (Part 1/Sec 9) : 2024
Medical electrical equipment Part 1 General requirements for basic safety and essential performance Section 9 Requirements for environmentally conscious design
-
Modified/Technically Equivalent
12.
IS 13450 (Part 1/Sec 10) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 10 Requirements for the development of physiologic closed-loop controllers (First Revision)
-
Modified/Technically Equivalent
13.
IS 13450 (Part 1/Sec 11) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance , Section 11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (First Revison)
-
Modified/Technically Equivalent
14.
IS 13450 (Part 1/Sec 12) : 2024
Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
-
Modified/Technically Equivalent
15.
IS 13450 (Part 2/Sec 1) : 2018
IEC 60601-2-1 :2009
Reviewed In : 2023
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 1 Electron accelerators in the range 1 MeV to 50 MeV (First Revision)
March, 2023
-
Identical under dual numbering
16.
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
-
Modified/Technically Equivalent
17.
IS 13450 (Part 2/Sec 2) : 2019
IEC 60601-2-2 : 2017
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 2 high frequency surgical equipment and high frequency surgical accessories
-
Modified/Technically Equivalent
18.
IS 13450 : 2022
60601-2-3:2012
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 3 Short wave therapy equipment
-
Modified/Technically Equivalent
19.
IS 13450 (Part 2/Sec 3) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment First revision
-
Modified/Technically Equivalent
20.
IS 13450 (Part 2/Sec 4) : 2018
IEC 60601-2-4 : 2010
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision)
August, 2023
1
Identical under dual numbering
21.
IS 13450 (Part 2/Sec 5) : 2018
IEC 60601-2-5 : 2009
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 5 ultrasonic physiotherapy equipment (First Revision)
August, 2023
-
Identical under dual numbering
22.
IS 13450 (Part 2/Sec 6) : 2018
IEC 60601-2-6 : 2012
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 6 microwave therapy equipment
August, 2023
-
Identical under dual numbering
23.
IS 13450 (Part 2/Sec 8) : 2019
IEC 60601-2-8 : 2015
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 8 Therapeutic X-ray equipment operating in the range 10 kV to 1 MV
-
Identical under dual numbering
24.
IS 13450 (Part 2/Sec 10) : 2018
IEC 60601-2-10 : 2012
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 10 nerve and muscle stimulators
July, 2023
-
Identical under dual numbering
25.
IS 13450 (Part 2/Sec 11) : 2018
IEC 60601-2-11 : 2013
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 11 gamma beam therapy equipment (First Revision)
August, 2023
-
Identical under dual numbering
26.
IS 13450 (Part 2/Sec 16) : 2019
IEC 60601-2-16 : 2018
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 16 haemodialysis, haemodiafiltration and haemofiltration equipment
-
Identical under dual numbering
27.
IS 13450 (Part 2/Sec 17) : 2018
IEC 60601 -2-17 : 2018
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 17 automatically - Controlled brachytherapy afterloading equipment (First Revision)
August, 2023
-
Identical under dual numbering
28.
IS 13450 (Part 2/Sec 18) : 2014
IEC 60601-2-18 : 2009
Reviewed In : 2019
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 18 endoscopic equipment
November, 2019
-
Identical under dual numbering
29.
IS 13450 (Part 2/Sec 19) : 2023
IEC 60601-2-19:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision
-
Identical under dual numbering
30.
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
-
Identical under dual numbering
31.
IS 13450 (Part 2/Sec 21) : 2023
IEC 60601-2-21:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision
-
Identical under dual numbering
32.
IS 13450 (Part 2/Sec 22) : 2021
IEC 60601-2-22:2019
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision
-
Identical under dual numbering
33.
IS 13450 (Part 2/Sec 23) : 2018
IEC 60601-2-23 : 2011
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 23 transcutaneous partial pressure monitoring equipment
August, 2023
1
Identical under dual numbering
34.
IS 13450 (Part 2/Sec 24) : 2019
IEC 60601-2-24 ; 2012
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 24 infusion pumps and controllers (First Revision)
-
Identical under dual numbering
35.
IS 13450 (Part 2/Sec 25) : 2018
IEC 60601-2-25 : 2011
Reviewed In : 2023
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs
March, 2023
1
Identical under dual numbering
36.
IS 13450 (Part 2/Sec 26) : 2021
IEC 80601-2-26 : 201
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs
-
Identical under dual numbering
37.
IS 13450 (Part 2/Sec 27) : 2018
IEC 60601-2-27 : 2011
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 27 electrocardiographic monitoring equipment
March, 2023
-
Identical under dual numbering
38.
IS 13450 (Part 2/Sec 29) : 2018
IEC 60601-2-29 : 2008
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 29 radiotherapy simulators (First Revision)
October, 2023
-
Identical under dual numbering
39.
IS 13450 (Part 2/Sec 31) : 2021
IEC 60601-2-31:2020
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
-
Identical under dual numbering
40.
IS 13450 (Part 2/Sec 33) : 2018
IEC 60601-2-33 : 2015
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 33 magnetic resonance equipment for medical diagnosis
December, 2023
-
Identical under dual numbering
41.
IS 13450 (Part 2/Sec 34) : 2019
IEC 60601-2-34 : 2011
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment
-
Identical under dual numbering
42.
IS 13450 (Part 2/Sec 35) : 2023
IEC 60601-2-35:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets pads or mattresses and intended for heating in medical use
-
Identical under dual numbering
43.
IS 13450 (Part 2/Sec 36) : 2019
IEC 60601-2-36 : 2014
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 36 equipment for extra corporeally induced lithotripsy
-
Identical under dual numbering
44.
IS 13450 (Part 2/Sec 37) : 2019
IEC 60601-2-37 : 2017
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 37 ultrasonic medical diagnostic and monitoring equipment
-
Identical under dual numbering
45.
IS 13450 (Part 2/Sec 39) : 2019
IEC 60601-2-39 : 2018
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 39 peritoneal dialysis equipment
-
Identical under dual numbering
46.
IS 13450 (Part 2/Sec 40) : 2020
IEC 60601-2-40 : 2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 40 Electromyographs and evoked response equipment
-
Identical under dual numbering
47.
IS 13450 (Part 2/Sec 41) : 2020
IEC 60601-2-41 : 2009
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis
-
Identical under dual numbering
48.
IS 13450 (Part 2/Sec 43) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures Second revision
-
Modified/Technically Equivalent
49.
IS 13450 (Part 2/Sec 43) : 2016
IEC 60601-2-43 : 2010
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 43 X-ray equipment for interventional procedures (First Revision)
May, 2021
2
Modified/Technically Equivalent
50.
IS 13450 (Part 2/Sec 44) : 2016
IEC 60601-2-44 : 2009
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 44 X-ray equipment for computed tomography (First Revision)
May, 2021
1
Identical under dual numbering
51.
IS 13450 (Part 2/Sec 45) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices Second revision
-
Modified/Technically Equivalent
52.
IS 13450 (Part 2/Sec 45) : 2016
IEC 60601-2-45 : 2011
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 45 mammographic X-ray equipment and mammographic stereotactic devices (First Revision)
May, 2021
-
Modified/Technically Equivalent
53.
IS 13450 (Part 2/Sec 46) : 2020
IEC 60601-2-46 : 2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables
-
Identical under dual numbering
54.
IS 13450 (Part 2/Sec 47) : 2018
IEC 60601-1-2 : 2014
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 47 ambulatory electrocardiographic systems
June, 2023
-
Identical under dual numbering
55.
IS 13450 (Part 2/Sec 50) : 2022
IEC 60601-2-50:2020
Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment
-
Identical under dual numbering
56.
IS 13450 (Part 2/Sec 52) : 2020
IEC 60601-2-52 : 2015
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds
-
Identical under dual numbering
57.
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
-
Modified/Technically Equivalent
58.
IS 13450 (Part 2/Sec 54) : 2016
IEC 60601-2-54 : 2009
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 54 X-ray equipment for radiography and radioscopy
May, 2021
2
Modified/Technically Equivalent
59.
IS 13450 (Part 2/Sec 62) : 2018
IEC 60601-2-62 : 2013
Reviewed In : 2023
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 62 high intensity therapeutic ultrasound (Hitu) equipment
August, 2023
-
Identical under dual numbering
60.
IS 13450 (Part 2/Sec 63) : 2016
IEC 60601-2-63 : 2012
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 63 dental extra - Oral X-ray equipment
May, 2021
1
Identical under dual numbering
61.
IS 13450 (Part 2/Sec 65) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision
-
Modified/Technically Equivalent
62.
IS 13450 (Part 2/Sec 65) : 2016
IEC 60601-2-65 : 2012
Reviewed In : 2021
Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 65 dental intra - Oral X-ray equipmen
May, 2021
1
Modified/Technically Equivalent
63.
IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 68 X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
-
Identical under dual numbering
64.
IS 13450 (Part 2/Sec 76) : 2019
IEC 60601-2-76 : 2018
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 76 low energy ionized gas haemostasis equipment
-
Identical under dual numbering
65.
IS/ISO 13450-2-10) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators First revision
-
Identical under dual numbering
66.
IS/ISO 13450-2-10 : 2018
IEC 60601-2-10 : 2012
Reviewed In : 2023
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 10 Nerve and muscle stimulators
March, 2023
-
Identical under dual numbering
67.
IS 13709 : 1993
Reviewed In : 2015
Medical electrical equipment - Dental X-ray equipment radiation safety
-
Indigenous
68.
IS 14180 : 2019
IEC 60878 : 2015
Graphical symbols for electrical equipment in medical practice (First Revision)
-
Identical under dual numbering
69.
IS/ISO 14708-2 : 2019
ISO 14708-2:2019
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers First Revision
-
Identical under single numbering
70.
IS 15584 : 2005
Reviewed In : 2022
Medical X-ray films
July, 2022
-
Indigenous
71.
IS 18448 (Part 1) : 2024
Medical electrical equipment Diagnostic X-rays Part 1 Determination of quality equivalent filtration and permanent filtration
-
Modified/Technically Equivalent
72.
IS 18448 (Part 2) : 2024
Medical electrical equipment Diagnostic X-rays Part 2 Guidance and rationale on quality equivalent filtration and permanent filtration
-
Modified/Technically Equivalent
73.
IS 18470 : 2024
Ultrasonics Physiotherapy Systems Field Specifications and Methods of Measurement in the Frequency Range 05 MHz to 5 MHz
-
Modified/Technically Equivalent
74.
IS/ISO 4090 : 2001
Reviewed In : 2023
Photography - Medical radiographic cassettes/screens/films and hard - Copy imaging films - Dimensions and specifications
July, 2023
-
Indigenous
75.
IS/IEC 60335-2-27) : 2009
IEC 60335-2-27 : 200
Household and Similar Electrical Appliances Safety Part 2-27 Particular Requirements for Appliances for Skin Exposure to Optical Radiation
-
Identical under single numbering
76.
IS/IEC 60336 : 2005
Reviewed In : 2020
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
October, 2020
-
Identical under single numbering
77.
IS/IEC 60580 : 2019
IEC 60580:2019
Medical electrical equipment Dose area product meters
-
Identical under single numbering
78.
IS/IEC/TR 60788 : 2004
IEC/TR 60788:2004
Reviewed In : 2020
Medical electrical equipment - Glossary of defined terms
April, 2020
-
Identical under single numbering
79.
IS/IEC 61168 : 1993
IEC 61168 : 1993
Radiotherapy simulators - Functional performance characteristics
-
Identical under single numbering
80.
IS/IEC 61170 : 1993
IEC 61170 : 1993
Radiotherapy simulators - Guidelines for functional performance characteristics
-
Identical under single numbering
81.
IS/IEC 61217 : 2011
IEC 61217 : 2011
Radiotherapy Equipment - Coordinates, Movements and Scales
-
Identical under single numbering
82.
IS/IEC 61262-1 : 1994
Reviewed In : 2020
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers
February, 2020
-
Identical under single numbering
83.
IS/IEC 61262-2 : 1994
Reviewed In : 2019
Medical electrical equipment characteristics of electro - Optical X-ray image intensifiers: Part 2 determination of the conversion factor
December, 2019
-
Identical under single numbering
84.
IS/IEC 61262-3 : 1994
IEC 61262_3 : 1994
Reviewed In : 2021
Medical electrical equipment - Characteristics of Electro - Optical X-ray image intensifiers: Part 3 determination of the luminance distribution and luminance non - Uniformity
December, 2021
-
Identical under single numbering
85.
IS/IEC 61262-4 : 1994
IEC 61262-4:1994
Reviewed In : 2020
Medical Electrical Equipment - Characteristics of Electro-Optical X-Ray Image Intensifiers Part 4 Determination of the Image Distortion
April, 2020
-
Identical under dual numbering
86.
IS/IEC 61331-1 : 2014
IEC 61331-1 : 2014
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 1: DETERMINATION OF ATTENUATION PROPERTIES OF MATERIALS
-
Identical under dual numbering
87.
IS/IEC 61331-2 : 2014

Protective Devices Against Diagnostic Medical X-Radiation Part 2 Translucent Protective Plates
-
Identical under single numbering
88.
IS/IEC 61331-3 : 2014
IEC 61331-3 : 2014
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3: PROTECTIVE CLOTHING, EYEWEAR AND PROTECTIVE PATIENT SHIELDS
-
Identical under dual numbering
89.
IS/IEC 61675-1 : 2022
IEC 61675-1:2022
Radionuclide Imaging Devices — Characteristics and Test Conditions Part 1 Positron Emission Tomographs (First Revision)
-
Identical under single numbering
90.
IS/IEC 61675-1 : 2013
IEC 61675-1 : 2013
Reviewed In : 2023
Radionuclide imaging devices - Characteristics and test conditions: Part 1 positron emission tomographs
March, 2023
-
Identical under single numbering
91.
IS/IEC 61675-2 : 2015
IEC 61675-2 : 2015
Radionuclide imaging devices - Characteristics and test conditions: Part 2 gamma cameras for planar, whole body, and spect imaging
-
Identical under single numbering
92.
IS/IEC 61676 : 2002
IEC 61676:2002
Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
-
Identical under single numbering
93.
IS/IEC 61685 : 2001
IEC 61685 : 2001
Ultrasonics - Flow measurement systems - Flow test object
-
Identical under single numbering
94.
IS/IEC 61847 : 1998
IS/IEC 61847 : 1998
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
-
Identical under single numbering
95.
IS/IEC/TR 61948-3 : 2018
IEC TR 61948-3 : 2018
Reviewed In : 2023
Nuclear medicine instrumentation - Routine tests: Part 3 positron emission tomographs
April, 2023
-
Identical under single numbering
96.
IS/IEC 62083 : 2009
IEC 62083:2009
Medical electrical equipment Requirements for the safety of radiotherapy treatment planning systems
-
Identical under single numbering
97.
IS/IEC 62220-1-1) : 2015
IEC 62220-1-1 : 2015
Medical Electrical Equipment — Characteristics of Digital X-ray Imaging Devices Part 1-1 Determination of the Detective Quantum Efficiency — Detectors Used in Radiographic Imaging
-
Identical under single numbering
98.
IS/IEC 62220-1-3 : 2008
IEC 62220-1-3:2008
Reviewed In : 2023
Medical electrical equipment-characteristics of digital X-ray imaging devices – Part:1-3 Determination of the detective quantum efficiency - Detectors used in dynamic imaging
March, 2023
-
Identical under dual numbering
99.
IS/IEC 62220-1- 2 : 2007
IEC 62220-1-2 : 2007
Reviewed In : 2022
Medical electrical equipment - Characteristics of digital X-ray imaging devices: Part 1 - 2 determination of the detective quantum efficiency detectors used in mammography
May, 2022
-
Identical under single numbering
100.
IS/IEC 6235 : 2014
IEC 62353 : 2014
Reviewed In : 2017
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (First Revision)
December, 2017
-
Identical under single numbering
101.
IS/IEC/TS 62556 : 2014
IEC TS 62556 : 2014
Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
-
Identical under single numbering
102.
IS/IEC 62563-1 : 2016
IEC 62563-1 : 2016
Medical Electrical Equipment — Medical Image Display System Part 1 Evaluation Method
-
103.
IS/IEC/TS 62566 : 2014
IEC TS 62556 : 2014
Ultrasonics — Field Characterization — Specification and Measurement of Field Parameters for High Intensity Therapeutic Ultrasound ( HITU ) Transducers and Systems
-
Identical under single numbering
104.
IS 7620 (Part 1) : 1986
Reviewed In : 2019
Specification for diagnostic medical X-ray equipment: Part 1 general and safety requirements (First Revision)
December, 2019
3
Indigenous
105.
IS 7620 (Part 2) : 1986
Reviewed In : 2019
Specification for diagnostic medical X-ray equipment: Part 2 performance requirements (First Revision)
December, 2019
1
Indigenous
106.
IS 7620 (Part 3) : 1991
Reviewed In : 2016
Medical electrical equipment - Diagnostic X-ray equipmbnts: Part 3 radiation safety requirements
December, 2016
-
Indigenous
107.
IS/IEC 80601-2-35) : 2009
IEC 80601-2-35 : 2009
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets, pads or mattresses and intended for heating in medical use
-
Identical under single numbering
108.
IS/IEC 80601-2-49) : 2018
IEC 80601-2-49:2018
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors
-
Identical under single numbering
109.
IS/ISO 80601-2-56) : 2017
ISO 80601-2-56 : 2017
Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 56 clinical thermometers for body temperature measurement
1
Identical under single numbering
110.
IS/IEC 80601-2-58) : 2016
IEC 80601-2-58:2016
Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery
-
Identical under single numbering
111.
IS/IEC 80601-2-59) : 2017
IEC 80601-2-59 : 2017
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 59 Screening thermographs for human febrile temperature screening
-
Identical under dual numbering
112.
IS/ISO 80601-2-61) : 2017
ISO 80601-2-61:2017
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
-
Identical under single numbering

Standards Under Develpoment

Projects Approved

SI. No.
Doc No
TITLE
No Records Found

Preliminary Draft Standards

SI. No.
Doc No
TITLE
No Records Found

Drafts Standards in WC Stage

SI. No.
Doc No
TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
1
MHD 15 (25328)
Medical electrical equipment Dosimeters with ionization chambers as used in Radiotherapy IEC 60731 2011AMD1 2016 CSV MOD

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
1
MHD 15 (24688)
Revision of: IS 13450:2018
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 33 Magnetic resonance equipment for medical diagnosis IEC 60601-2-33 2022 MOD First Revision
2
MHD 15 (24715)
Revision of: IS 13450:2020
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis IEC 60601-2-41 2021 MOD First Revision
3
MHD 15 (24718)
Revision of: IS 13450:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables IEC 60601-2-46 2023 MOD First Revision
4
MHD 15 (24732)
Revision of: IS 13450:2018
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 6 Particular requirements for the basic safety and essential performance of microwave therapy equipment IEC 60601-2-6 2022 MOD First Revision
5
MHD 15 (24734)
Revision of: IS/IEC 62563:2016
Medical Electrical Equipment Medical Image Display Systems Part 1 Evaluation methods First Revision
6
MHD 15 (25315)
Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 75 Photodynamic therapy and photodynamic diagnosis equipment
7
MHD 15 (25327)
Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 83 Home light therapy equipment

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 15 (22659)
Medical electrical equipment X-ray tube assemblies for medical diagnosis Focal spot dimensions and related characteristics
2
MHD 15 (22670)

Revision of: IS 13450:2016
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 63 Dental extra-oral X-ray equipment First revision


Aspect Wise Report

 
 Product:   59
 Code of Practices :    2
 Methods of Test :   16
 Terminology :   2
 Dimensions :   1
 System Standard :   0
 Safety Standard :   4
 Others :    10
 Service Specification :    0
 Process Specification :    0
 Unclassified :    10
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
IS 10550 : 1983
Reviewed In : 2016
Specification for medical treatment lamps
2.
IS 10554 : 1983
Reviewed In : 2006
Radiographic intensifying screens for medical use - dimensions
3.
IS 11302 (Part 1) : 1985
Reviewed In : 2016
Electro-encephalograph EEG - Part 1 General and Safety Requirements
4.
IS 11302 (Part 2) : 1985
Reviewed In : 2016
Specification for electroencephalograph EEG Part 2 performance requirements
5.
IS 11331 : 1985
Reviewed In : 2016
Electrical Muscle and Nerve Stimulators for Therapeutic Purpose
6.
IS 11478 (Part 1) : 1985
Reviewed In : 2016
Application guide for medical electrical equipment Part 1 General requirements and electrical installations
7.
IS 11478 (Part 2) : 1985
Reviewed In : 2016
Application guide for medical electrical equipment Part 2 Safety provisions application operation and maintenance
8.
IS 11661 : 1986
Reviewed In : 2016
Safety of Lung Ventilator for Medical Use
9.
IS 11701 : 1986
Reviewed In : 2021
Guide for testing and calibration of ultrasonic therapeutic equipment
10.
IS 11754 : 1986
Reviewed In : 2016
Implantable Ventricular Pacemaker
11.
IS 12311 : 1987
Reviewed In : 2016
Microwave Diathermy Equipment for Therapeutic Purposes
12.
IS 13069 : 1991
Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
13.
IS 13450 (Part 1/Sec 1) : 2006
IEC 60601-1-1
Reviewed In : 2011
Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 Collateral Standard - Safety Requirements for Medical Electrical System
14.
IS 13450 (Part 1/Sec 4) : 2009
IEC 60601-1-1
Reviewed In : 2014
Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 Collateral Standard - Safety Requirements for Medical Electrical System
15.
IS 13450 (Part 2/Sec 7) : 2006
IEC 60601-2-7
Reviewed In : 2011
Medical Electrical Equipment Part 2 Particular Requirements for the Safety Section 7 High-Voltage Generators of Diagnostic X-Ray Generators
16.
IS 13450 (Part 2/Sec 30) : 2008
IEC 60601-2-30
Reviewed In : 2018
Medical electrical equipment Part 2 particular requirements for the safety Sec 30 essential performance of automatic cycling non - Invasive blood pressure monitoring equipmen
17.
IS 13450 (Part 2/Sec 32) : 2006
IEC 60601-2-32
Reviewed In : 2011
Medical Electrical Equipment Part 2 Particular requirements for safety Section 32 Associated equipment of X-Ray equipment
18.
IS 13450 (Part 2/Sec 49) : 2018
IEC 60601 Par 2 Section 49 : 2011
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 49 multifunction patient monitoring equipment First Revision
19.
IS 13523 (Part 1) : 1992
Reviewed In : 2016
Medical Electrical Equipment - Shortwave Therapy Equipment Part 1 General And Safety Requirements
20.
IS 13523 (Part 2) : 1992
Reviewed In : 2016
Medical Electrical Equipment - Shortwave Therapy Equipment Part 2 Performance Requirements
21.
IS 13812 (Part 19) : 1994
IEC 601-2-19
Reviewed In : 2015
Medical electrical equipment - Particular requirements for safety Part 19 Baby incubators
22.
IS 13814 : 1993
IEC 858
Reviewed In : 2015
Determination of the image distortion of electro - Optical X-ray image intensifiers
23.
IS/IEC 61689 : 2013
IEC 61689 : 2013
Reviewed In : 2023
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0 5 mhz to 5 mhz
24.
IS/IEC/TR 61852 : 1998
IEC TR 61852 : 1998
Medical electrical equipment - Digital imaging and communications in medicine DICOM - Radiotherapy objects
25.
IS/IEC/TR 61859 : 1997
IEC/TR 61859 : 1997
Guidelines for Radiotherapy Treatment Rooms Design
26.
IS 6991 : 1985
Radiographic Cassettes
27.
IS 7352 : 1974
Reviewed In : 2017
Specification for X-ray lead - Rubber protective aprons
28.
IS 7583 : 1991
Reviewed In : 2016
Medical Electrical Equipment - High Frequency Surgical Equipment
29.
IS 8048 : 1985
Reviewed In : 2016
Specification for electrocardiograph First Revision
30.
IS 8607 (Part 1) : 1977
Reviewed In : 1987
General and safety requirements for electrical equipment used in medical practice Part 1 General
31.
IS 8607 (Part 2) : 1978
Reviewed In : 1987
General and safety requirements for electrical equipment used in medical practice Part 2 Protection against electric shock
32.
IS 8885 : 1994
Reviewed In : 2019
Medical electrical equipment electromyograph - Specification First Revision
33.
IS 9286 (Part 1) : 1988
Reviewed In : 2010
Cardiac Defibrillators - Part 1 Safety Requirements


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
IS 11393 : 1985
Reviewed In : 2021
Specification for scintillation counters
2.
IS 11753 : 1986
Reviewed In : 2021
Specification for electrical impedance plethysmograph
3.
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
4.
IS 13450 (Part 2/Sec 3) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 3 Short-wave therapy equipment First revision
5.
IS 13450 (Part 2/Sec 4) : 2018
IEC 60601-2-4 : 2010
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 4 cardiac defibrillators First Revision
6.
IS 13450 (Part 2/Sec 5) : 2018
IEC 60601-2-5 : 2009
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 5 ultrasonic physiotherapy equipment First Revision
7.
IS 13450 (Part 2/Sec 6) : 2018
IEC 60601-2-6 : 2012
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 6 microwave therapy equipment
8.
IS 13450 (Part 2/Sec 8) : 2019
IEC 60601-2-8 : 2015
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 8 Therapeutic X-ray equipment operating in the range 10 kV to 1 MV
9.
IS 13450 (Part 2/Sec 11) : 2018
IEC 60601-2-11 : 2013
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 11 gamma beam therapy equipment First Revision
10.
IS 13450 (Part 2/Sec 16) : 2019
IEC 60601-2-16 : 2018
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 16 haemodialysis haemodiafiltration and haemofiltration equipment
11.
IS 13450 (Part 2/Sec 18) : 2014
IEC 60601-2-18 : 2009
Reviewed In : 2019
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 18 endoscopic equipment
12.
IS 13450 (Part 2/Sec 19) : 2023
IEC 60601-2-19:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 19 Infant Incubators First Revision
13.
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
14.
IS 13450 (Part 2/Sec 21) : 2023
IEC 60601-2-21:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 21 Infant Radiant Warmer First Revision
15.
IS 13450 (Part 2/Sec 22) : 2021
IEC 60601-2-22:2019
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 22 surgical cosmetic therapeutic and diagnostic laser equipment First Revision
16.
IS 13450 (Part 2/Sec 24) : 2019
IEC 60601-2-24 ; 2012
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 24 infusion pumps and controllers First Revision
17.
IS 13450 (Part 2/Sec 25) : 2018
IEC 60601-2-25 : 2011
Reviewed In : 2023
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 25 Electrocardiographs
18.
IS 13450 (Part 2/Sec 26) : 2021
IEC 80601-2-26 : 201
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 26 Electroencephalographs
19.
IS 13450 (Part 2/Sec 27) : 2018
IEC 60601-2-27 : 2011
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 27 electrocardiographic monitoring equipment
20.
IS 13450 (Part 2/Sec 29) : 2018
IEC 60601-2-29 : 2008
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 29 radiotherapy simulators First Revision
21.
IS 13450 (Part 2/Sec 31) : 2021
IEC 60601-2-31:2020
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
22.
IS 13450 (Part 2/Sec 33) : 2018
IEC 60601-2-33 : 2015
Reviewed In : 2023
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 33 magnetic resonance equipment for medical diagnosis
23.
IS 13450 (Part 2/Sec 34) : 2019
IEC 60601-2-34 : 2011
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 34 Invasive blood pressure monitoring equipment
24.
IS 13450 (Part 2/Sec 35) : 2023
IEC 60601-2-35:2020
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets pads or mattresses and intended for heating in medical use
25.
IS 13450 (Part 2/Sec 36) : 2019
IEC 60601-2-36 : 2014
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 36 equipment for extra corporeally induced lithotripsy
26.
IS 13450 (Part 2/Sec 37) : 2019
IEC 60601-2-37 : 2017
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 37 ultrasonic medical diagnostic and monitoring equipment
27.
IS 13450 (Part 2/Sec 39) : 2019
IEC 60601-2-39 : 2018
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 39 peritoneal dialysis equipment
28.
IS 13450 (Part 2/Sec 40) : 2020
IEC 60601-2-40 : 2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 40 Electromyographs and evoked response equipment
29.
IS 13450 (Part 2/Sec 41) : 2020
IEC 60601-2-41 : 2009
Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 41 Surgical luminaires and luminaires for diagnosis
30.
IS 13450 (Part 2/Sec 43) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 43 X-ray equipment for interventional procedures Second revision
31.
IS 13450 (Part 2/Sec 45) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 45 Mammographic X-ray equipment and mammographic stereotactic devices Second revision
32.
IS 13450 (Part 2/Sec 46) : 2020
IEC 60601-2-46 : 2016
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 46 Operating tables
33.
IS 13450 (Part 2/Sec 50) : 2022
IEC 60601-2-50:2020
Medical electrical equipment Part 2 Particular requirements for the Basic Safety and essential performance Section 50 Infant Phototherapy Equipment
34.
IS 13450 (Part 2/Sec 52) : 2020
IEC 60601-2-52 : 2015
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 52 Medical beds
35.
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
36.
IS 13450 (Part 2/Sec 63) : 2016
IEC 60601-2-63 : 2012
Reviewed In : 2021
Medical electrical equipment Part 2 particular requirements for the basic safety and essential performance Sec 63 dental extra - Oral X-ray equipment
37.
IS 13450 (Part 2/Sec 65) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 65 Dental intra-oral X-ray equipment First revision
38.
IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 68 X-ray-based image-guided radiotherapy equipment for use with electron accelerators light ion beam therapy equipment and radionuclide beam therapy equipment
39.
IS 13450 (Part 2/Sec 76) : 2019
IEC 60601-2-76 : 2018
Medical electrical equipment Part 2 particular requirements for basic safety and essential performance Sec 76 low energy ionized gas haemostasis equipment
40.
IS/ISO 13450-2-10) : 2024
Medical electrical equipment Part 2 Particular requirements for basic safety and essential performance Section 10 Nerve and muscle stimulators First revision
41.
IS 13709 : 1993
Reviewed In : 2015
Medical electrical equipment - Dental X-ray equipment radiation safety
42.
IS/ISO 14708-2 : 2019
ISO 14708-2:2019
Implants for surgery Active implantable medical devices Part 2 Cardiac pacemakers First Revision
43.
IS 15584 : 2005
Reviewed In : 2022
Medical X-ray films
44.
IS/ISO 4090 : 2001
Reviewed In : 2023
Photography - Medical radiographic cassettes screens films and hard - Copy imaging films - Dimensions and specifications
45.
IS/IEC 60335-2-27) : 2009
IEC 60335-2-27 : 200
Household and Similar Electrical Appliances Safety Part 2-27 Particular Requirements for Appliances for Skin Exposure to Optical Radiation
46.
IS/IEC 60580 : 2019
IEC 60580:2019
Medical electrical equipment Dose area product meters
47.
IS/IEC 61168 : 1993
IEC 61168 : 1993
Radiotherapy simulators - Functional performance characteristics
48.
IS/IEC 61331-3 : 2014
IEC 61331-3 : 2014
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION PART 3 PROTECTIVE CLOTHING EYEWEAR AND PROTECTIVE PATIENT SHIELDS
49.
IS/IEC 61675-2 : 2015
IEC 61675-2 : 2015
Radionuclide imaging devices - Characteristics and test conditions Part 2 gamma cameras for planar whole body and spect imaging
50.
IS/IEC 61685 : 2001
IEC 61685 : 2001
Ultrasonics - Flow measurement systems - Flow test object
51.
IS/IEC 61847 : 1998
IS/IEC 61847 : 1998
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
52.
IS 7620 (Part 1) : 1986
Reviewed In : 2019
Specification for diagnostic medical X-ray equipment Part 1 general and safety requirements First Revision
53.
IS 7620 (Part 2) : 1986
Reviewed In : 2019
Specification for diagnostic medical X-ray equipment Part 2 performance requirements First Revision
54.
IS 7620 (Part 3) : 1991
Reviewed In : 2016
Medical electrical equipment - Diagnostic X-ray equipmbnts Part 3 radiation safety requirements
55.
IS/IEC 80601-2-35) : 2009
IEC 80601-2-35 : 2009
Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 35 Heating devices using blankets pads or mattresses and intended for heating in medical use
56.
IS/IEC 80601-2-49) : 2018
IEC 80601-2-49:2018
Medical electrical equipment Part 2- Particular requirements for basic safety and essential performance- Sec 49 Multifunction patient monitors
57.
IS/ISO 80601-2-56) : 2017
ISO 80601-2-56 : 2017
Medical electrical equipment Part 2 particular requirements for basic safety and essential performance Sec 56 clinical thermometers for body temperature measurement
58.
IS/IEC 80601-2-58) : 2016
IEC 80601-2-58:2016
Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery
59.
IS/ISO 80601-2-61) : 2017
ISO 80601-2-61:2017
Medical electrical equipment Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment