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Indian Standard Details

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Basic Details
IS Number : IS/ISO 11137-3 : 2017
ISO 11137-3 : 2017

IS Title [Eng-Hn] : Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 12 ( Hospital Equipment and Surgical Disposable Products )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Sterilizers & incubators
Aspects: Others
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 11137-3 : 2017
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 11137 : Part 3 : 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 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
3
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
International Standards Refered In IS/ISO 11137 : Part 3 : 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 11137 : Part 3 : 2017 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 5840 : Part 3 : 2013 Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques MHD 6
2 IS 12725 : 2021 Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision ) PGD 36
3 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
4 IS 17667 : 2021 Vegetable fats and oils Determination of phospholipids content in lecithins by HPLC using a light-scattering detector FAD 13
5 IS 17061 : 2019 Practice for dosimetry in radiation processing CHD 30
6 IS/ISO/IEC 10779 : 2020 Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities LITD 36
7 IS/ISO/IEC 10779 : 2020 Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities LITD 36