Indian Standard Details

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IS Number : IS 13450 (Part 1) : 2018
IEC 60601-1 : 2012 (Ed 3.1)
Reviewed In : 2023
IS Title [Eng-Hn] : Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)
No of Revision : 2
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 15 ( Electromedical, Diagnostic Imaging and Radiotherapy Equipment )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Diagnostic Instruments
Sub Sub Group : Surgical, Diagnostic equipment and General safety requirements
Aspects: Others
Certification:
Ministry :
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:IEC 60601-1:2020
Organisation :

Indian Standards Refered In IS IS 13450 : Part 1 : 2018 :
SNo IS Number Title Technical Committee
1
IS 616 : 2017 Audio, video and similar electronic apparatus - Safety requirements (Fifth Revision) LITD 7
2
IS/IEC 60079 : PART 0 : 2017 Explosive Atmospheres Part 0 Equipment — General Requirements ( Third Revision ) ETD 22
3
IS/IEC 60079 : PART 2 : 2014 Explosive atmospheres: Part 2 equipment protection by pressurized enclosure "P" (First Revision) ETD 22
4
IS/IEC 60079 : PART 5 : 2015 Explosive atmospheres: Part 5 equipment protection by powder filling "Q" (First Revision) ETD 22
5
IS/IEC 60079 Part 6 : 2015 Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" (Second Revision) ETD 22
6
IS 1271 : 2012 Electrical insulation - Thermal evaluation and designation (Second Revision) ETD 2
7
IS 6303 : Part 4 : 2013 Primary batteries: Part 4 safety of lithium batteries (Second Revision) ETD 10
8
IS/IEC 60127 : PART 1 : 2006 Miniature fuses: Part 1 definitions for miniature fuses and general requirements for miniature fuse - Links (First Revision) ETD 39
9
IS/IEC 60320 : PART 1 : 2001 Appliance couplers for household and similar general purposes: Part 1 general requirements ETD 14
10
IS 15382 : Part 1 : 2022 Insulation Coordination for Equipment Within Low-Voltage Systems Part 1 Principles Requirements and Tests ETD 19
11
IS 13778 : Part 3 : 2012 Winding wires - Test methods: Part 3 mechanical properties (First Revision) ETD 33
12
IS 13778 : Part 5 : 2012 Winding wires - Test methods: Part 5 electrical properties (First Revision) ETD 33
13
IS 13252 : Part 1 : 2010 Information technology equipment - Safety: Part 1 general requirements (Second Revision) LITD 7
14
IS 15575 : Part 1 : 2016 Electroacoustics - Sound level meters: Part 1 specifications (First Revision) LITD 7
15
IS 16046 : Part 1 : 2018 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes — Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for Use in Portable Applications Part 1 Nickel Systems ( Second Revision ) ETD 11
16
IS 16046 : Part 2 : 2018 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes — Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for Use in Portable Applications Part 2 Lithium Systems ( Second Revision ) ETD 11
17
IS/ISO 62304 : 2015 Medical device software - Software life cycle processes MHD 14
18
IS/IEC 62368 : Part 1 : 2018 Audio / Video, Information and Communication Technology Equipment Part 1 Safety Requirements ( First Revision ) LITD 7
19
IS 1260 : Part 2 : 2020 Packaging — Distribution Packaging — Graphical Symbols for Handling and Storage of Packages Part 2 General Goods ( Fourth Revision ) TED 24
20
IS 16449 : Part 1 : 2018 Graphical symbols - Safety colours and safety signs: Part 1 design principles for safety signs and safety markings PGD 1
21
IS/ISO 5349 : Part 1 : 2001 Mechanical vibration - Measurement and evaluation of human exposure to handtransmitted vibration: Part 1 general requirements (First Revision) MED 28
22
IS 16450 : 2023 Graphical Symbols for Use on Equipment Registered Symbols PGD 1
23
IS 16451 : 2023 Graphical Symbols Safety Colours and Safety Signs Registered Safety Signs PGD 1
24
IS/ISO 11137 : Part 1 : 2006 Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices MHD 12
25
IS 16814 : 2021 SAFETY OF MACHINERY SAFETY DISTANCES TO PREVENT HAZARD ZONES BEING REACHED BY UPPER AND LOWER LIMBS MED 40
26
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
27
IS/ISO 15223 : Part 1 : 2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) MHD 14
28
IS 13867 : 2021 Rubber - General Procedures for Preparing and Conditioning Test Pieces for Physical Test Methods ( First Revision ) PCD 29
29
IS/ISO 80000 : Part 1 : 2022 Quantities and Units Part 1 General PGD 1
30
IS 16621 : 2017 Positive list of constituents of polyethylene and polypropylene in contact with foodstuffs, pharmaceuticals and drinking water PCD 12
31
IS 16648 : Part 1 : 2017 Concentrated solar thermal - Specification: Part 1 paraboloid dish concentrator MED 4
32
IS/ISO 10993 : Part 10 : 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization MHD 19
33
IS/ISO 10993 : Part 15 : 2000 Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys MHD 19
International Standards Refered In IS 13450 : Part 1 : 2018
SNo International Standard Number
1 IEC 60038 : 1983
2 IEC 60086 : 4 : 2000
3 IEC 60107 : 1 : 1997
4 IEC 60127 : 6 : 0 0
5 IEC 60227 : 2 : 1997
6 IEC 60320 : 0 : 0 0
7 IEC 60410 : 1973
8 IEC 60695 : 11 : 5 2004
9 IEC 60730 : 1 : 2010
10 IEC 60747 : 5 : 5 2007
11 IEC 60825 : 1 : 2007
12 IEC 60906 : 0 : 0 0
13 IEC 60990 : 0 : 0 0
14 IEC 60998 : 2 : 2
15 IEC 60999 : 1 : 0 0
16 IEC 61032 : 1997
17 IEC 61058 : 1 : 2000
18 IEC 61149 : 0 : 0 0
19 IEC 61293 : 0 : 0 0
20 IEC 61558 : 1 : 2005
21 IEC 61558 : 2 : 16
22 IEC 61558 : 2 : 17
23 IEC 61965 : 0 : 0 0
24 IEC 62133 : 0 : 0 0
25 IEC 62151 : 2000
26 IEC 104 : 0 : 0 0
27 IEC 112 : 0 : 0 0
28 ISO 2859 : 1 : 1999
29 ISO 7000 : 0 : 0 0
30 ISO 9773 : 0 : 0 0
31 IEC 60027 : 0 : 0 0
32 IEC 60068 : 2 : 6 2007
33 IEC 60068 : 2 : 31 2008
34 IEC 60068 : 2 : 75
35 IEC 60068 : 2 : 78
36 IEC 60085 : 0 : 0 0
37 IEC 60112 : 0 : 0 0
38 IEC 60127 : 0 : 0 0
39 IEC 60167 : 1964
40 IEC 60216 : 0 : 0 0
41 IEC 60227 : 0 : 0 0
42 IEC 60245 : 0 : 0 0
43 IEC 60249 : 2 : 0 0
44 IEC 60268 : 1 : 1985
45 IEC 60317 : 43 : 0 0
46 IEC 60335 : 1 : 0 0
47 IEC 60384 : 1 : 2008
48 IEC 60384 : 14 : 2005
49 IEC 60417 : 0 : 0 0
50 IEC 60454 : 0 : 0 0
51 IEC 60529 : 1989
52 IEC 60664 : 1 : 2007
53 IEC 60664 : 3 : 0 0
54 IEC 60691 : 2002
55 IEC 60695 : 2 : 2 1991
56 IEC 60707 : 1999
57 IEC 60851 : 3 : 1 2009
58 IEC 60884 : 0 : 0 0
59 IEC 60950 : 1 : 2005
60 IEC 61051 : 2 : 1991
61 IEC 61260 : 0 : 0 0
62 ISO 261 : 0 : 0 0
63 ISO 262 : 0 : 0 0
64 ISO 306 : 2004
65 IEC 60038 : 1983
66 IEC 60086 : 4 : 2000
67 IEC 60107 : 1 : 1997
68 IEC 60127 : 6 : 0 0
69 IEC 60227 : 2 : 1997
70 IEC 60320 : 0 : 0 0
71 IEC 60410 : 1973
72 IEC 60695 : 11 : 5 2004
73 IEC 60730 : 1 : 2010
74 IEC 60747 : 5 : 5 2007
75 IEC 60825 : 1 : 2007
76 IEC 60906 : 0 : 0 0
77 IEC 60990 : 0 : 0 0
78 IEC 60998 : 2 : 2
79 IEC 60999 : 1 : 0 0
80 IEC 61032 : 1997
81 IEC 61058 : 1 : 2000
82 IEC 61149 : 0 : 0 0
83 IEC 61293 : 0 : 0 0
84 IEC 61558 : 1 : 2005
85 IEC 61558 : 2 : 16
86 IEC 61558 : 2 : 17
87 IEC 61965 : 0 : 0 0
88 IEC 62133 : 0 : 0 0
89 IEC 62151 : 2000
90 IEC 104 : 0 : 0 0
91 IEC 112 : 0 : 0 0
92 ISO 2859 : 1 : 1999
93 ISO 7000 : 0 : 0 0
94 ISO 9773 : 0 : 0 0
95 IEC 60027 : 0 : 0 0
96 IEC 60068 : 2 : 6 2007
97 IEC 60068 : 2 : 31 2008
98 IEC 60068 : 2 : 75
99 IEC 60068 : 2 : 78
100 IEC 60085 : 0 : 0 0
101 IEC 60112 : 0 : 0 0
102 IEC 60127 : 0 : 0 0
103 IEC 60167 : 1964
104 IEC 60216 : 0 : 0 0
105 IEC 60227 : 0 : 0 0
106 IEC 60245 : 0 : 0 0
107 IEC 60249 : 2 : 0 0
108 IEC 60268 : 1 : 1985
109 IEC 60317 : 43 : 0 0
110 IEC 60335 : 1 : 0 0
111 IEC 60384 : 1 : 2008
112 IEC 60384 : 14 : 2005
113 IEC 60417 : 0 : 0 0
114 IEC 60454 : 0 : 0 0
115 IEC 60529 : 1989
116 IEC 60664 : 1 : 2007
117 IEC 60664 : 3 : 0 0
118 IEC 60691 : 2002
119 IEC 60695 : 2 : 2 1991
120 IEC 60707 : 1999
121 IEC 60851 : 3 : 1 2009
122 IEC 60884 : 0 : 0 0
123 IEC 60950 : 1 : 2005
124 IEC 61051 : 2 : 1991
125 IEC 61260 : 0 : 0 0
126 ISO 261 : 0 : 0 0
127 ISO 262 : 0 : 0 0
128 ISO 306 : 2004
IS 13450 : Part 1 : 2018 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 14679 : 1999 Neurosurgical implants - Implantable peripheral nerve stimulators MHD 7
2 IS 11364 : 1994 Anaesthetic Reservoir Bags MHD 11
3 IS 7409 : Part 1 : 2003 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1 : Cones and Sockets MHD 11
4 IS 11754 : 1986 Implantable Ventricular Pacemaker MHD 15
5 IS 11661 : 1986 Safety of Lung Ventilator for Medical Use MHD 15
6 IS 13523 : Part 1 : 1992 Medical Electrical Equipment - Shortwave Therapy Equipment: Part 1 General And Safety Requirements MHD 15
7 IS 13523 : Part 2 : 1992 Medical Electrical Equipment - Shortwave Therapy Equipment: Part 2 Performance Requirements MHD 15
8 IS/ISO 14708 : Part 3 : 2017 Implants for surgery - Active implantable medical devices: Part 3 implantable neurostimulators (First Revision) MHD 7
9 IS/IEC 60645 : Part 1 : 2017 Electroacoustics - Audiometric equipment: Part 1 equipment for pure - Tone and speech audiometry LITD 7
10 IS/IEC 60645 : Part 7 : 2009 Electroacoustics - Audiometric equipment: Part 7 instruments for the measurement of auditory brainstem responses LITD 7
11 IS/ISO 14708 : Part 1 : 2014 Implants for surgery - Active implantable medical devices: Part 1 general requirements for safety, marking and for information to be provided by the manufacturer (First Revision) MHD 7
12 IS/ISO 22523 : 2006 External limb prostheses and external orthoses - Requirements and test methods MHD 9
13 IS/IEC 61204 : Part 3 : 2016 Low-Voltage Switch Mode Power Supplies Part 3 Electromagnetic Compatibility ( EMC ) ETD 31
14 IS 13450 : Part 2 : Sec 68 : 2020 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 MHD 15
15 IS 13450 : Part 4 : Sec 1 : 2020 Medical electrical equipment: Part 4 Guidance and interpretation: Section 1 Medical electrical equipment and medical electrical systems employing a degree of autonomy PGD 18
16 IS 15500 : PART 8 : 2004 DEEPWELL HANDPUMPS, COMPONENTS AND SPECIAL TOOLS SPECIFICATION PART 8 SPECIAL TOOLS MED 27
17 IS/IEC 61217 : 2011 Radiotherapy Equipment - Coordinates, Movements and Scales MHD 15
18 IS 14423 : 2021 Fluid Power Systems and Components - Connectors and Associated Components - Nominal Pressures ( First Revision ) PGD 36
19 IS 17426 : 2020 ICU Ventilators for use in COVID-19 — Specification MHD 11
20 IS/ISO 10524 : Part 3 : 2005 Pressure regulators for use with medical gases: Part 3 pressure regulators integrated with cylinder valves MHD 11
21 IS/ISO 27427 : 2013 Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components MHD 11
22 IS/IEC 60071 : Part 1 : 2006 Insulation Co-ordination Part 1 Definitions, Principles and Rules ETD 19
23 IS 1180 : Part 3 : 2021 Outdoor/Indoor Type Liquid Immersed Distribution Transformers Up to and Including 2 500 kVA, 33 kV — Specification Part 3 Natural/Synthetic Organic Ester Liquid Immersed ETD 16
24 IS/ISO 8596 : 2017 Ophthalmic optics Visual acuity testing Standard and clinical optotypes and their presentation First Revision MHD 5
25 IS 16693 : 2021 Reference sources - Calibration of surface contamination monitors - Alpha beta and photon emitters (First Revision) CHD 30
26 IS 13450 : Part 2 : Sec 22 : 2019 Medical electrical equipment: Part 2 particular requirements for basic safety and essential performance: Sec 22 surgical, cosmetic, therapeutic and diagnostic laser equipment MHD 15
27 IS 13450 : Part 2 : Sec 31 : 2019 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 31 external cardiac pacemakers with internal power source MHD 15
28 IS 398 : Part 6 : 2021 Aluminium Conductors For Overhead Transmission Purposes Part 6: High conductivity aluminium alloy stranded conductors ETD 37
29 IS 548 : Part 3 : Sec 7 : 2021 METHODS OF SAMPLING AND TEST FOR OILS AND FATS PART 3 ADVANCED INSTRUMENTAL METHODS SECTION 7 DETERMINATION OF PHOSPHORUS CONTENT BY GRAPHITE FURNACE ATOMIC ABSORPTION SPECTROMETRIC METHOD (Adoption of ISO 10540-2 : 2003) FAD 13
30 IS 5402 : Part 1 : 2021 Microbiology of the food chain - Horizontal method for the enumeration of microorganisms- Part 1: Colony count at 30 C by the pour plate technique FAD 31
31 IS/ISO 5971 : 2017 Textiles Size designation of clothes Tights TXD 20
32 IS/ISO 80601 : Part 2 : Sec 61 : 2011 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 61 pulse oximeter equipment MHD 15
33 IS 13450 : Part 2 : Sec 26 : 2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 26 Electroencephalographs MHD 15
34 IS/ISO 11197 : 2016 Medical supply units MHD 11
35 IS 5815 : Part 2 : 2021 Textiles - Fishing gear materials - Methods of test Part 2: Determination of linear density mass per unit length (first revision) TXD 18
36 IS/ISO 2408 : 2017 Steel wire ropes Requirements MED 10
37 IS 13450 : Part 2 : Sec 19 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 19 baby incubator MHD 15
38 IS 13450 : Part 2 : Sec 20 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 20 infant transport incubators MHD 15
39 IS 13450 : Part 2 : Sec 21 : 2018 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 21 infant radiant warmer MHD 15
40 IS 17614 : Part 20 : 2021 Water Quality Sampling Part 20 Guidance on the Use of Sampling Data for Decision Making Compliance with Thresholds and Classification Systems CHD 36
41 IS 2032 : Part 19 : 1977 Graphical symbols used in electrotechnology: Part 19 electrical equipment used in medical practice ETD 1
42 IS 17791 : Part 2 : 2022 Protective equipment for martial arts: Part 2: Additional requirements and test methods for instep protectors shin protectors and forearm protectors PGD 41
43 IS 17791 : Part 4 : 2022 Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors PGD 41
44 IS 582 : Part 9 : 2022 METHODS OF CHEMICAL TESTING OF LEATHER Part 9 Determination of pH and difference figure CHD 17
45 IS 582 : Part 13 : 2022 METHODS OF CHEMICAL TESTING OF LEATHER Part 13 Determination of total silicon content Reduced molybdosilicate spectrometric method CHD 17
46 IS 582 : Part 14 : 2022 METHODS OF CHEMICAL TESTING OF LEATHER Part 14 DETERMINATION OF MATTER SOLUBLE IN DICHLOROMETHANE AND FREE FATTY ACID CONTENT CHD 17
47 IS 11852 : 2013 Automotive Vehicles - Uniform Provisions Concerning the Approval of Vehicles of Categories M, N and T with Regard to Braking TED 4
48 IS/IEC 61557 : Part 1 : 2019 ELECTRICAL SAFETY IN LOW VOLTAGE DISTRIBUTION SYSTEMS UP TO 1000 V AC AND 1500 V DC - EQUIPMENT FOR TESTING MEASURING OR MONITORING OF PROTECTIVE MEASURES: PART 1 GENERAL REQUIREMENTS ETD 12
49 IS 101 : Part 2 : Sec 4 : 2022 Methods of sampling and test for paints varnishes and related products Part 2 Test on liquid paints chemical examination Section 4 Determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision) CHD 20
50 IS 3025 : Part 17 : 2022 Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 17 Non- Filterable Residue Total Suspended Solids at 103 C - 105 C (Second Revision) CHD 36
51 IS 3160 : 2022 Tur Chuni as Livestock Feed Ingredient � Specification FAD 5
52 IS 3161 : 2022 Gram Chuni as Livestock Feed Ingredient � Specification FAD 5
53 IS 14794 : 2022 ISOBUTENE-ISOPRENE RUBBER IIR EVALUATION PROCEDURES Third Revision PCD 29
54 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
55 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
56 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
57 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15