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Basic Details/ मूल ब्यौरा
Comment
IS Number/
आईएस संख्या
:
IS 18593:2024
IS Title/
आईएस शीर्षक
:
Copper-Bearing Contraceptive Intrauterine Devices - Requirements and Tests (ISO 7439 : 2023, MOD (Second Revision)
Superseding IS/
सुपरसीडिंग आईएस
:
IS/ISO 7439 : 2015
Degree of Equivalence/
समतुल्यता स्तर
:
Modified/Technically Equivalent
Number of Revisions/
पुनरीक्षणों की संख्या
:
2
Number of Amendments/
संशोधनों की संख्या
:
No amendment issued
Aspect/
पक्ष
:
Product Specification
Language/
भाषा
:
English
Reaffirmation Year/
पुनर्पुष्टि वर्ष
:
Technical Department/
तकनीकी विभाग
:
MHD (Medical Equipment and Hospital Planning Department)
Technical Committee/
तकनीकी समिति
:
MHD 03 (Obstetric and Gynaecological Instruments and Appliances Sectional Committee)
Member Secretary/
सदस्य सचिव
:
Ms. GURPREET KAUR BHOMBRA (SCIENTIST-C)
Other Details
Indian Standard
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Amendment : 0
Gazette Document : 6
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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
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Indian Standards Referred In IS IS 18593:2024
:
1
IS 18852 (Part 1):2024
ISO 7755-1:2013
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)
MHD 19
2
IS/ISO 14155 : 2020
Clinical investigation of medical devices for human subjects - Good clinical practice
MHD 19
3
IS 18076 : 2023
Non-active surgical implants - General requirements
MHD 02
4
IS 17781:2021
Medical devices - Application of risk management to medical devices First Revision
MHD 14
5
IS 18852 (Part 1):2024
ISO 7755-1:2013
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)
MHD 19
6
IS/ISO 14155 : 2020
Clinical investigation of medical devices for human subjects - Good clinical practice
MHD 19
7
IS 18076 : 2023
Non-active surgical implants - General requirements
MHD 02
8
IS 17781:2021
Medical devices - Application of risk management to medical devices First Revision
MHD 14
International Standards Referred In IS 18593:2024
1
ISO 15223 : 1 : 2021
2
ASTM 3078 : 0 : 0 0
3
ASTM 1929 : 0 : 0 0
IS 18593:2024
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 09
Classification Details
Group
:
Medical and Hospital Equipments
Sub Group
:
Surgical instruments and accessories
Sub Sub Group
:
Gynaecology instruments and Contraception devices
Aspect
:
Product Specification
Certification
:
