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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014

IS Title/आईएस शीर्षक : 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

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under dual numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Product Specification

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 15 (Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. GURPREET KAUR BHOMBRA (SCIENTIST-C)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 1

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License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

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Cross Reference Details

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Composition

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Corrigendum : 0

Cross Reference Details

Indian Standards Referred In IS IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014
:

1	IS 13450 (Part 1) : 2024	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
2	IS 13450 (Part 2/Sec 1) : 2018 IEC 60601-2-1 :2009 Reviewed In : 2023	Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 1 Electron accelerators in the range 1 MeV to 50 MeV (First Revision)	MHD 15
3	IS 13450 (Part 2/Sec 44) : 2016 IEC 60601-2-44 : 2009 Reviewed In : 2021	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 44 X-ray equipment for computed tomography (First Revision)	MHD 15
4	IS 13450 (Part 2/Sec 4) : 2018 IEC 60601-2-4 : 2010 Reviewed In : 2023	Medical electrical equipment: Part 2 particular requirements for the basic safety and essential performance: Sec 4 cardiac defibrillators (First Revision)	MHD 15
5	IS/IEC/TR 60788 : 2004 IEC/TR 60788:2004 Reviewed In : 2020	Medical electrical equipment - Glossary of defined terms	MHD 15
6	IS 13450 (Part 1/Sec 3) : 2024	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance: Sec 3 collateral standard: radiation protection in diagnostic X-ray equipment	MHD 15
7	IS 7937 : 2012 ISO 4568 Reviewed In : 2022	Shipbuilding - Sea - Going vessels - Windlasses and anchor capstans (Third Revision)	TED 19

International Standards Referred In IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014

1	IEC 60731 : 2011
2	IEC 60976 : 2007
3	IEC 61217 : 2011
4	IEC 61223 : 3 : 5 2004
5	IEC 61262 : 7 : 1995
6	IEC 62083 : 2009
7	IEC 62274 : 2005
8	IEC 62366 : 2007
9	IEC 62396 : 1 : 2012
10	IEC 62563 : 1 : 2009

IS 13450 (Part 2/Sec 68) : 2020
IEC 60601-2-28 : 2014
is Referred in following Indian Standards :

1	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

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Diagnostic Instruments
Sub Sub Group	:	Imaging and Radiotherapy equipment
Aspect	:	Product Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:	Medical Electrical equipment
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	IEC 60601-2-68 : 201
Harmonized with	:

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 13450 : Part 2 : Sec 68 : 2020

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 1

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS 13450 : Part 2 : Sec 68 : 2020

List of Expired or Cancelled Licenses under IS : IS 13450 : Part 2 : Sec 68 : 2020

List of laboratories for : IS 13450 : Part 2 : Sec 68 : 2020

List of Amendement(s) for : IS 13450 : Part 2 : Sec 68 : 2020

List of Gazette Document(s) for : IS 13450 : Part 2 : Sec 68 : 2020

List of Corigenda Document(s) for : IS 13450 : Part 2 : Sec 68 : 2020

List of Product Manuals & SIT