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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18446 (Part 1) : 2023
ISO 11140-1:2014

IS Title/आईएस शीर्षक : Sterilization of health care products Chemical indicators Part 1: General requirements

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 : Product 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 18446 (Part 1) : 2023
ISO 11140-1:2014
:

1	IS/ISO 8601 : Part 1 : 2019	Date and Time Representations For Information Interchange Part 1: Basic Rules	MSD 5
2	IS 19026 (Part 15) : 2023 ISO 12614-15:2021	Date and Time Representations For Information Interchange Part 2: Extensions	MSD 5
3	IS/ISO 11135 : 2014 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 11137-1 : 2006 ISO 11137-1 : 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
5	IS/ISO 11137-2 : 2013 ISO 11137-2 : 2013	Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose	MHD 12
6	IS/ISO 11137-3 : 2017 ISO 11137-3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
7	IS/ISO 11138-1 : 2017 ISO 11138-1 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 1 General Requirements	MHD 12
8	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
9	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
10	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
11	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
12	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
13	IS 18139 : Part 1 : 2023	Industrial Screen Specification Part 1 Woven Wire Cloth Screen	CED 55
14	IS/ISO 8601 : Part 1 : 2019	Date and Time Representations For Information Interchange Part 1: Basic Rules	MSD 5
15	IS 19026 (Part 15) : 2023 ISO 12614-15:2021	Date and Time Representations For Information Interchange Part 2: Extensions	MSD 5
16	IS/ISO 11135 : 2014 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
17	IS/ISO 11137-1 : 2006 ISO 11137-1 : 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
18	IS/ISO 11137-2 : 2013 ISO 11137-2 : 2013	Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose	MHD 12
19	IS/ISO 11137-3 : 2017 ISO 11137-3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
20	IS/ISO 11138-1 : 2017 ISO 11138-1 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 1 General Requirements	MHD 12
21	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
22	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
23	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
24	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
25	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
26	IS 18139 : Part 1 : 2023	Industrial Screen Specification Part 1 Woven Wire Cloth Screen	CED 55

International Standards Referred In IS 18446 (Part 1) : 2023
ISO 11140-1:2014

Standard contains no Cross Referenced International Standard.

IS 18446 (Part 1) : 2023
ISO 11140-1:2014
is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Health care facilities
Sub Sub Group	:	Sterilizers & incubators
Aspect	:	Product 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 11140-1:2014
Harmonized with	:	ISO

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

List of Licenses under IS : IS 18446 : 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 : 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 18446 : Part 1 : 2023

List of Expired or Cancelled Licenses under IS : IS 18446 : Part 1 : 2023

List of laboratories for : IS 18446 : Part 1 : 2023

List of Amendement(s) for : IS 18446 : Part 1 : 2023

List of Gazette Document(s) for : IS 18446 : Part 1 : 2023

List of Corigenda Document(s) for : IS 18446 : Part 1 : 2023

List of Product Manuals & SIT