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Indian Standard Details

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Basic Details
IS Number : IS/ISO 13408-1 : 2008
ISO 13408-1:2008
IS Title [Eng-Hn] : Aseptic processing of health care products Part 1 General requirements
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 : Quality Management of hospitals
Aspects: Code of Practice
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 13408-1:2008
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 13408 : Part 1 : 2008 :
SNo IS Number Title Technical Committee
1
IS/ISO 9001 : 2015 Quality management systems - Requirements (Fourth Revision) MSD 2
2
IS 10654 : 2018 Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision) MHD 12
3
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
4
IS/ISO 13485 : 2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) MHD 14
5
IS 8293 : 1976 Specification for phenthoate, technical FAD 1
6
IS 9000 : Part 20 : 1979 Basic environmental testing procedures for electronic and electrical items: Part 20 resistance to cleaning solvents and permanence of markings LITD 1
7
IS 9000 : Part 21 : 1985 Basic environmental testing procedures for electronic & electrical items: Part 21 acoustics noise test LITD 1
International Standards Refered In IS/ISO 13408 : Part 1 : 2008
SNo International Standard Number
1 ISO 9000 : 2005
IS/ISO 13408 : Part 1 : 2008 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 3937 : Part 2 : 2022 RECOMMENDATIONS FOR SOCKETING OF WIRE ROPES - PART 2 SOCKETING WITH WHITE METAL Second Revision MED 10
2 IS 4707 : Part 4 : 2022 Classification Of Cosmetic Raw Materials And Adjuncts -List of UV Filters Allowed In Cosmetics With Restriction-IS 4707 Part 4
3 IS 4883 : 2023 KHOA � SPECIFICATION (Second Revision of IS 4883) FAD 19