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Indian Standard Details

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Basic Details
IS Number : IS 13450 (Part 1/Sec 10) : 2019
IEC 60601-1-10 : 2013

IS Title [Eng-Hn] : 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
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 15 ( Electromedical, Diagnostic Imaging and Radiotherapy Equipment )
Language : English

Classification Details
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 60601-1-10:2020
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS 13450 : Part 1 : Sec 10 : 2019 :
SNo IS Number Title Technical Committee
1
IS/ISO 14971 : 2019 Medical devices - Application of risk management to medical devices First Revision MHD 14
2
IS/ISO 9000 : 2015 Quality management systems - Fundamentals and vocabulary (Fourth Revision) MSD 2
3
IS 16483 : 2017 Geosynthetics - Method for microscopic evaluation of the dispersion of carbon black in polyolefin geosynthetics TXD 30
4
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
5
IS/ISO 10993 : Part 10 : 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization MHD 19
6
IS 6659 : 1976 Electronic Grade Ceramic Materials ETD 2
International Standards Refered In IS 13450 : Part 1 : Sec 10 : 2019
SNo International Standard Number
1 EN 14164 : 0 : 2014 0
IS 13450 : Part 1 : Sec 10 : 2019 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/IEC 80601 : Part 2 : Sec 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 MHD 15
2 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
3 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
4 IS 17754 : Part 1 : 2022 Agricultural grain driers - Determination of drying performance-Part1:General FAD 20
5 IS 17791 : Part 4 : 2022 Protective equipment for martial arts: Part 4: Additional requirements and test methods for head protectors PGD 41
6 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
7 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
8 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
9 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