Indian Standard Details

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IS Number : IS 18319 : 2023
ISO 17665-1:2006

IS Title [Eng-Hn] : Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
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

Group : Medical and Hospital Equipments
Sub Group: Medical and Hospital Equipments
Sub Sub Group : Allied hospital equipment
Aspects: Process Specification
Certification:
Ministry :
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under dual numbering
Identical/Equivalent Standards:ISO 17665:2024
Organisation :

Indian Standards Refered In IS IS 18319 : Part 1 : 2023 :
SNo IS Number Title Technical Committee
1
IS/ISO 11138 : Part 1 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements MHD 12
2
IS/ISO 11138 : Part 3 : 2017 Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes MHD 12
3
IS 18446 : Part 1 : 2023 Sterilization of health care products Chemical indicators Part 1: General requirements MHD 12
4
IS/ISO 11140 : Part 3 : 2007 Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test MHD 12
5
IS/ISO 11140 : Part 4 : 2007 Sterilization of health care products - Chemical indicators: Part 4 class 2 indicators as an alternative to the bowie and dick - Type test for detection of steam penetration MHD 12
6
IS/ISO 11140 : Part 5 : 2007 Sterilization of health care products - Chemical indicators: Part 5 class 2 indicators for bowie and dick - Type air removal tests MHD 12
7
IS/ISO 11607 : Part 1 : 2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision MHD 12
8
IS/ISO 11607 : Part 2 : 2019 Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) MHD 12
9
IS/ISO 11737 : Part 1 : 2018 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products MHD 12
10
IS/ISO 11737 : Part 2 : 2019 Sterilization of health care products Microbiological methods Part 2 Tests of sterility performed in the definition validation and maintenance of a sterilization process MHD 12
11
IS 15994 : Part 3 : 2019 Information and documentation - Records management process - Metadata for records: Part 3 self - Assessment method MSD 5
International Standards Refered In IS 18319 : Part 1 : 2023
SNo International Standard Number
1 ISO 11737 : 1 : 2006
2 ISO 14937 : 2009
3 ISO 17665 : 1 : 2006
4 ISO 18472 : 2006
IS 18319 : Part 1 : 2023 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 16412 : 2023 Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors MTD 33
2 IS/IEC 61970 : Part 301 : 2022 Energy management system application program interface EMS-API Part 301: Common information model CIM base LITD 10