Indian Standard Details

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IS Number : IS/ISO 14971 : 2019
ISO 14971:2019

IS Title [Eng-Hn] : Medical devices - Application of risk management to medical devices First Revision
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 14 ( Hospital Planning )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Quality Management of hospitals
Aspects: Code of Practice
Certification:
Ministry : Ministry of Consumer Affairs, Food and Public Distribution - Department of Food and Public Distribution
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 14971 : 2019
Organisation :

Indian Standards Refered In IS IS/ISO 14971 : 2019 :
SNo IS Number Title Technical Committee
Standard contains no Cross Referenced Indian Standard.
Standard contains no Cross Referenced Indian Standard.
International Standards Refered In IS/ISO 14971 : 2019 Standard contains no Cross Referenced International Standard.
IS/ISO 14971 : 2019 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 3565 : 1966 Rubber Teats for Feeding Bottles PCD 13
2 IS 3025 : Part 71 : 2021 Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 71 Determination of Dissolved Cations Using Ion Chromatography CHD 36
3 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
4 IS 17567 : Part 1 : 2021 ISO TS 19807-1:2019 Nanotechnologies Magnetic nanomaterials Part 1: Specification of characteristics and measurements for magnetic nanosuspensions MTD 33
5 IS 17652 : 2021 Soy Butter FAD 16
6 IS 17667 : 2021 Vegetable fats and oils Determination of phospholipids content in lecithins by HPLC using a light-scattering detector FAD 13
7 IS 16048 : Part 2 : 2021 SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES SECONDARY SEALED CELLS AND BATTERIES FOR PORTABLE APPLICATIONS PART 2: NICKEL-METAL HYDRIDE ETD 11
8 IS 1248 : Part 9 : 2021 Direct Acting Indicating Analogue Electrical Measuring Instruments and their Accessories Part 9 Recommended Test Methods (Fourth Revision) ETD 12
9 IS/ISO 26262 : Part 5 : 2018 Road vehicles Functional safety Part 5: Product development at the hardware level TED 11
10 IS 5501 : 2021 Specification for Pneumatic Tyred Roller (first revision) MED 7
11 IS/ISO 26262 : Part 11 : 2018 Road vehicles Functional safety Part 11: Guidelines on application of ISO 26262 to semiconductors TED 11
12 IS/ISO/TR 24971 : 2013 Medical devices - Guidance on the application of ISO 14971 MHD 14
13 IS 1205 : 2022 METHODS FOR TESTING TAR AND BITUMINOUS MATERIALS - Determination of Softening Point Ring and Ball Apparatus IS 1205 PCD 6
14 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 : Sec 4 determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision) CHD 20
15 IS 14473 : Part 3 : 2022 CRANES INSPECTIONS -- PART 3 TOWER CRANES MED 14
16 IS 17847 : 2022 Bensulfuron Methyl technical- Specification FAD 1
17 IS 17881 : Part 1 : 2022 Protective clothing against heat and flame - Part 1 Test method for complete garments - Measurement of transferred energy using an instrumented manikin TXD 32
18 IS/ISO 14155 : 2011 Clinical investigation of medical devices for human subjects - Good clinical practice MHD 19
19 IS 14268 : 2022 Uncoated Stress Relieved Low Relaxation Seven-Wire (Ply) Strand for Prestressed Concrete -Specification (Second Revision) CED 54
20 IS 1885 : Part 84 : 2022 Electrotechnical Vocabulary Part 84 Terminology Concerning Fire Tests for Electrotechnical Products (Third Revision) LITD 1
21 IS 11047 : 2022 TEXTILES POSTAL GREEN CASH BAGS SPECIFICATION TXD 20
22 IS 17706 : 2022 PULL HANDLES SPECIFICATION CED 15
23 IS 17883 : 2022 Geological Exploration for Tunnels Guidelines WRD 5
24 IS 1713 : 2022 Decorticated Groundnut Oilcake as Livestock Feed Ingredient � Specification FAD 5
25 IS 3161 : 2022 Gram Chuni as Livestock Feed Ingredient � Specification FAD 5
26 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
27 IS 13450 : Part 1 : SEC 2 : 2018 Medical electrical equipment: Part 1 general requirements for the basic safety and essential performance: Sec 2 collateral standard: electromagnetic disturbances - Requirements and tests (First Revision) MHD 15
28 IS 13450 : Part 1 : Sec 6 : 2020 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 6 Collateral standard: Usability MHD 15
29 IS 13450 : Part 1 : Sec 10 : 2019 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Section 10 Collateral standard: Requirements for the development of physiologic closed-loop controllers MHD 15
30 IS 13360 : Part 11 : Sec 15 : 2022 PLASTICS - METHODS OF TESTING PART 11 SPECIAL PROPERTIES Section 15 Determination of Viscosity using a Falling-Ball Viscometer Inclined-tube method PCD 27
31 IS 17960 : 2022 Dentistry Coiled springs for use in orthodontics MHD 8
32 IS/IEC 62488 : Part 3 : 2021 Power line communication systems for power utility applications Part 3: Digital Power Line Carrier DPLC Terminals and hybrid ADPLC Terminals LITD 10
33 IS 13450 : Part 2 : Sec 43 : 2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 43 X-ray equipment for interventional procedures (First Revision) MHD 15
34 IS 13450 : Part 2 : Sec 45 : 2016 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) MHD 15
35 IS 13450 : Part 2 : Sec 54 : 2016 Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 54 X-ray equipment for radiography and radioscopy MHD 15
36 IS/ISO 7396 : Part 1 : 2007 Medical gas pipeline systems: Part 1 pipeline systems for compressed medical gases and vacuum MHD 11
37 IS/ISO 7439 : 2015 Copper - Bearing contraceptive intrauterine devices - Requirements and tests (First Revision) MHD 3
38 IS/ISO 7439 : 2015 Copper - Bearing contraceptive intrauterine devices - Requirements and tests (First Revision) MHD 3
39 IS 3937 : Part 2 : 2022 RECOMMENDATIONS FOR SOCKETING OF WIRE ROPES - PART 2 SOCKETING WITH WHITE METAL Second Revision MED 10
40 IS 4707 : Part 4 : 2022 Classification Of Cosmetic Raw Materials And Adjuncts -List of UV Filters Allowed In Cosmetics With Restriction-IS 4707 Part 4
41 IS 14936 : 2022 Triazophos, technical concentrates - Specification FAD 1
42 IS 1366 : 2022 Slotted Cheese Head Screws � Product Grade A (Fourth Revision of IS 1366) PGD 37
43 IS/IEC 62680 : Part 1 : Sec 8 : 2019 Universal serial bus interfaces for data and power Part 1-8: Common components USB Audio 30 device class definition terminal types LITD 7
44 IS/ISO 10651 : Part 4 : 2002 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 particular requirements for operator - Powered resuscitators MHD 11
45 IS/ISO 10651 : Part 4 : 2002 Lung ventilators for medical use - Particular requirements for basic safety and essential performance: Part 4 particular requirements for operator - Powered resuscitators MHD 11
46 IS 4155 : 2023 Glossary of Terms Relating to Chemical and Radiation Hazards and Hazardous Chemicals (First Revision) CHD 7
47 IS 443 : Part 11 : 2023 METHODS OF TEST FOR RUBBER AND PLASTICS TUBING HOSES AND HOSE ASSEMBLIES PART 11 RUBBER AND PLASTICS HOSES AND TUBING MEASUREMENT OF FLEXIBILITY AND STIFFNESS BENDING TESTS AT SUB-AMBIENT TEMPERATURES ISO 10619-2 : 2021 IDT PCD 29
48 IS 16150 : Part 5 : 2023 IS 16150 Part 5 Fish feed Specification Part 5 Pangasius feed FAD 12
49 IS/ISO 14015 : 2022 Environmental management Guidelines for environmental due diligence assessment first revision EED 1
50 IS 16412 : 2023 Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors MTD 33
51 IS/ISO 1039 : 1995 CINEMATOGRAPHY - CORES FOR MOTION-PICTURE AND MAGNETIC FILM ROLLS DIMENSIONS ADOPTION OF ISO 1039: 1995 MED 32
52 IS 3803 : Part 2 : 2022 Steel Conversion of elongation values Part 2: Austenitic steels MTD 3