Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18319 : 2023
ISO 17665-1:2006

IS Title/आईएस शीर्षक : Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under dual numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Process Specification

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : No reaffirmation

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 12 (Hospital Equipment and Surgical Disposable Products Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. UROOSA WARSI (SCIENTIST-C)

Other Details

Indian Standard

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Amendment : 0

Gazette Document : 4

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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

Indian Standards Referred In IS IS 18319 : 2023
ISO 17665-1:2006
:

1	IS/ISO 11138-1 : 2017 ISO 11138-1 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 1 General Requirements	MHD 12
2	IS/ISO 11138-3 : 2017 ISO 11138-3 : 2017	Sterilization of Healthcare Products â€• 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 11140-3 : 2007 ISO 11140-3 : 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 11140-4 : 2007 ISO 11140-4 : 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 11140-5 : 2007 ISO 11140-5 : 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 17630 : 2021	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
8	IS 17642 : 2021 ISO 17828 : 2015	Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision)	MHD 12
9	IS 7016 (Part 23) : 2023 ISO 32100:2018	Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products	MHD 12
10	IS 5282 (Part 2) : 2023	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 ISO/TR23081-3 : 2011 Reviewed In : 2023	Information and documentation - Records management process - Metadata for records: Part 3 self - Assessment method	MSD 5

International Standards Referred In IS 18319 : 2023
ISO 17665-1:2006

Standard contains no Cross Referenced International Standard.

IS 18319 : 2023
ISO 17665-1:2006
is Referred in following Indian Standards :

1	IS/ISO 7396 : Part 1 : 2007	Medical gas pipeline systems: Part 1 pipeline systems for compressed medical gases and vacuum	MHD 11
2	IS 16150 : Part 5 : 2023	IS 16150 Part 5 Fish feed Specification Part 5 Pangasius feed	FAD 12
3	IS 17812 : Part 1 : 2022	Terminal Units for Medical Gas Pipeline Systems : Part 1 Terminal Units for use with Compressed Medical Gases and Vacuum (First Revision)	MHD 11

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Medical and Hospital Equipments
Sub Sub Group	:	Allied hospital equipment
Aspect	:	Process Specification
Certification	:	Voluntary Certification
Relevant Ministries	:	Ministry of Health and Family Welfare
Sustainable development Goals :
Short Commom Man's Title	:
ITC-HS Code	:
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	ISO 17665:2024
Harmonized with	:

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 18319 : Part 1 : 2023

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

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Basic Details/ मूल ब्यौरा

Other Details

Indian Standard

Amendment : 0

Gazette Document : 4

License : 0

Product Manual & SIT : 0

Laboratory : 0

Classification Details

Cross Reference Details

Composition

Corrigendum : 0

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS 18319 : Part 1 : 2023

List of Expired or Cancelled Licenses under IS : IS 18319 : Part 1 : 2023

List of laboratories for : IS 18319 : Part 1 : 2023

List of Amendement(s) for : IS 18319 : Part 1 : 2023

List of Gazette Document(s) for : IS 18319 : Part 1 : 2023

List of Corigenda Document(s) for : IS 18319 : Part 1 : 2023

List of Product Manuals & SIT