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Indian Standard Details

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Basic Details
IS Number : IS/ISO 25539-1 : 2017
ISO 25539-1 : 2017

IS Title [Eng-Hn] : Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)
No of Revision : 1
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 6 ( Medical and Surgical Cardiology Equipment )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Implants
Sub Sub Group : Cardiovascular surgery instrument and implants
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 25539 : Part 1
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 25539 : Part 1 : 2017 :
SNo IS Number Title Technical Committee
1
IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
2
IS/ISO 10993 : Part 1 : 2009 Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process MHD 19
3
IS/ISO 11137 : Part 1 : 2006 Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices MHD 12
4
IS/ISO 11135 : 2014 Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices MHD 12
5
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
6
IS/ISO 14971 : 2007 Medical devices - Application of risk management to medical devices MHD 14
7
IS 6171 : 1992 Screwing taps - Technical supply conditions (Second Revision) PGD 32
8
IS 6264 : 1994 J - acid, technical - Specification (First Revision) PCD 26
9
IS 7155 : Part 7 : 1990 Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision) MED 6
International Standards Refered In IS/ISO 25539 : Part 1 : 2017
SNo International Standard Number
1 0 0 : 0 : 0 0
2 ISO 9000 : 2015
3 ISO 9000 : 2015
4 ISO 0 : 0 : 0 0
5 ISO 9000 : 2015
6 ISO 9000 : 2015
7 ISO 0 : 0 : 0 0
8 ISO 9000 : 2015
9 ISO 9000 : 2015
10 ISO 15000 : 2015
11 ISO 0 : 0 : 0 0
12 ISO 9000 : 2015
13 ISO 0 : 0 : 0 0
IS/ISO 25539 : Part 1 : 2017 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
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
2 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
3 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
4 IS/ISO 25539 : Part 1 : 2017 Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision) MHD 6
5 IS/ISO 80000-10 : 2019 Quantities and units Part 10 : Atomic and nuclear physics PGD 1