Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18881 (Part 5) : 2024
ISO 13408-5:2006

IS Title/आईएस शीर्षक : Aseptic Processing of Health Care Products Part 5 Sterilization in Place

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 : 1

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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 18881 (Part 5) : 2024
ISO 13408-5:2006
:

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 11138-2 : 2017 ISO 11138-2 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes	MHD 12
3	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
4	IS/ISO 11138-4 : 2017 ISO 11138-4 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes	MHD 12
5	IS/ISO 11138-5 : 2017 ISO 11138-5 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes	MHD 12
6	IS 18469 : Part 7 : 2023	Sterilization of health care products Biological indicators Part 7: Guidance for the selection use and interpretation of results	MHD 12
7	IS 18469 : Part 8 : 2023	Sterilization of health care products Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator	MHD 12
8	IS 18446 : Part 1 : 2023	Sterilization of health care products Chemical indicators Part 1: General requirements	MHD 12
9	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
10	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
11	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
12	IS 18319 : Part 1 : 2023	Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices	MHD 12
13	IS/ISO 24536 : 2019 ISO 24536:2019	Software engineering Guidelines for the application of ISO 9001:2008 to computer software	LITD 14
14	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
15	IS 17553 : 2021 ISO 5518:2007	Crude coal tar for general use (Third Revision)	PCD 7

International Standards Referred In IS 18881 (Part 5) : 2024
ISO 13408-5:2006

Standard contains no Cross Referenced International Standard.

IS 18881 (Part 5) : 2024
ISO 13408-5:2006
is Referred in following Indian Standards :

1	IS/IEC 61970 : Part 301 : 2022	Energy management system application program interface EMS-API Part 301: Common information model CIM base	LITD 10
2	IS/IEC 61970 : Part 301 : 2022	Energy management system application program interface EMS-API Part 301: Common information model CIM base	LITD 10

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	:	N/A
Degree of Equivalence	:	Identical under dual numbering
Identical/Equivalent International Standard(s)	:	ISO 13408-5:2006
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18881 : Part 5 : 2024

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 : 1

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 18881 : Part 5 : 2024

List of Expired or Cancelled Licenses under IS : IS 18881 : Part 5 : 2024

List of laboratories for : IS 18881 : Part 5 : 2024

List of Amendement(s) for : IS 18881 : Part 5 : 2024

List of Gazette Document(s) for : IS 18881 : Part 5 : 2024

List of Corigenda Document(s) for : IS 18881 : Part 5 : 2024

List of Product Manuals & SIT