IS Details

IS Number :	IS 13450 (Part 1/Sec 10) : 2024
IS Title [Eng-Hn] :	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)
No of Revision :	1
No of Amendments :	0
Technical Department :	Medical Equipment and Hospital Planning Department
Technical Committee :	MHD 15 ( Electromedical, Diagnostic Imaging and Radiotherapy Equipment )
Language :	English

Certification:
Group :	Medical and Hospital Equipments
Sub Group:	Diagnostic Instruments
Sub Sub Group :	Surgical, Diagnostic equipment and General safety requirements
Aspects:	Others
Ministry :	Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence:	Modified/Technically Equivalent
Identical/Equivalent Standards:	IEC 60601-1-10:2020
Organisation :

Indian Standards Refered In IS IS 13450 : Part 1 : Sec 10 : 2024 :

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 : 2024

SNo	International Standard Number
1	EN 14164 : 0 : 2014 0

IS 13450 : Part 1 : Sec 10 : 2024 is Refered in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Bureau of Indian Standards