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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS/ISO 80601-2-61 : 2017
ISO 80601-2-61:2017
IS Title/
आईएस शीर्षक
:
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Superseding IS/
सुपरसीडिंग आईएस
:
None
Degree of Equivalence/
समतुल्यता स्तर
:
Identical under single numbering
Number of Revisions/
पुनरीक्षणों की संख्या
:
1
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 : 2
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License : 0
Product Manual & SIT : 0
Laboratory : 2
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Classification Details
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Cross Reference Details
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Composition
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Corrigendum : 0
Cross Reference Details
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Indian Standards Referred In IS IS/ISO 80601-2-61 : 2017
ISO 80601-2-61:2017
:
1
IS 9000 (Part 7/Sec 1) : 2018
IEC 60068-2-27 : 2008
Reviewed In : 2021
Basic environmental testing procedures for electronic and electrical items: Part 7 impact test: Sec 1 shock (Test Ea) (Second Revision)
LITD 1
2
IS 13200 : 2023
ISO 4135:2022
Anaesthetic and respiratory equipment - Vocabulary (First Revision)
MHD 11
3
IS 13450 (Part 1) : 2024
Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)
MHD 15
4
IS/ISO 14155 : 2020
ISO 14155: 2020
Clinical investigation of medical devices for human subjects - Good clinical practice
MHD 19
5
IS 14624 (Part 2) : 2012
IEC
Reviewed In : 2021
Safety of laser products: Part 2 safety of optical fibre communication systems (OFCS) (First Revision)
LITD 11
6
IS/ISO 15223-1 : 2016
ISO 15223-1 : 2016
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )
MHD 14
7
IS 16450 : 2023
ISO 7000:2019
Graphical symbols for use on equipment - Registered symbols
PGD 1
8
IS 16451 : 2023
ISO/IEC 7010 : 2019
Graphical Symbols- Safety Colours and Safety Signs- Registered Safety Signs
PGD 1
9
IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 ‘
Medical Devices Part 1 Application of Usability Engineering to Medical Devices
MHD 14
International Standards Referred In IS/ISO 80601-2-61 : 2017
ISO 80601-2-61:2017
1
ISO 3744 : 2010
2
ISO 14117 : 2019
3
ISO 14937 : 2009
4
IEC 60068 : 2 : 31 2008
5
IEC 60068 : 2 : 64 2008
6
IEC 60601 : 1 : 11 2015
7
IEC 60601 : 1 : 12 2014
IS/ISO 80601-2-61 : 2017
ISO 80601-2-61:2017
is Referred in following Indian Standards :
1
IS 14700 : Part 4 : Sec 1 : 2019
Electromagnetic compatibility (EMC): Part 4 testing and measurement techniques: Sec 1 overview of the IEC 61000 - 4 series (Second Revision)
LITD 9
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Diagnostic Instruments
Sub Sub Group
:
Equipment/Instruments used for diagnostic and clinical purpose
Aspect
:
Product Specification
Certification
:
Voluntary Certification
Relevant Ministries
:
Sustainable development Goals :
Short Commom Man's Title
:
ITC-HS Code
:
Degree of Equivalence
:
Identical under single numbering
Identical/Equivalent International Standard(s)
:
ISO 80601-2-61:2017
Harmonized with
:
ISO
Email Ids
ID
Mailing list
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1
Committee members email list
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3
Additional mailing list
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List of Licenses under IS : IS/ISO 80601 : Part 2 : Sec 61 : 2017
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Expired or Cancelled Licenses
List of Expired or Cancelled Licenses under IS : IS/ISO 80601 : Part 2 : Sec 61 : 2017
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Active Licenses
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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
List of laboratories for : IS/ISO 80601 : Part 2 : Sec 61 : 2017
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#
Lab Name
Address
City
State
Contact Number
Email Id
View Scope
List of Amendement(s) for : IS/ISO 80601 : Part 2 : Sec 61 : 2017
#
Amendment Number
Amendment Year
File Name
Action
List of Gazette Document(s) for : IS/ISO 80601 : Part 2 : Sec 61 : 2017
#
IS/Amendment Number
SO. No.
Action
List of Corigenda Document(s) for : IS/ISO 80601 : Part 2 : Sec 61 : 2017
#
IS/Amendment Number
File Name
Action
List of Product Manuals & SIT
#
File Type
File Name
Action
Total Visitors -
7
1
3
9
2
1
QCO File Details
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