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Indian Standard Details

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Basic Details
IS Number : IS/IEC 80601-2-58 : 2016
IEC 80601-2-58:2016
IS Title [Eng-Hn] : 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
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 : Imaging and Radiotherapy equipment
Aspects: Product Specification
Certification:
Ministry :
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:IEC 80601-2-58:2016
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/IEC 80601 : Part 2 : Sec 58 : 2016 :
SNo IS Number Title Technical Committee
1
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
2
IS/ISO 11607 : Part 2 : 2006 Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes MHD 12
3
IS/ISO 11607 : Part 1 : 2006 Packaging for terminally sterilized medical devices: Part 1 requirements for materials, sterile barrier systems and packaging systems MHD 12
4
IS 13450 : Part 2 : Sec 2 : 2019 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 MHD 15
5
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
International Standards Refered In IS/IEC 80601 : Part 2 : Sec 58 : 2016
SNo International Standard Number
1 IEC 61000 : 3 : 2 2020
2 IEC 61000 : 3 : 3 2021
3 IEC 61000 : 4 : 3 2020
4 IEC 61000 : 4 : 4 2012
5 IEC 61000 : 4 : 5 2017
6 IEC 61000 : 4 : 39 2017
7 ISO 7637 : 2 : 2011
IS/IEC 80601 : Part 2 : Sec 58 : 2016 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.