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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 18880 : 2024
ISO 13004:2022

IS Title/आईएस शीर्षक : Sterilization of Health Care Products ï¿½ Radiation ï¿½ Substantiation of Selected Sterilization Dose: Method VDmaxSD

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 18880 : 2024
ISO 13004:2022
:

1	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
2	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
3	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

International Standards Referred In IS 18880 : 2024
ISO 13004:2022

Standard contains no Cross Referenced International Standard.

IS 18880 : 2024
ISO 13004:2022
is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

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	:
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 13004:2022
Harmonized with	:

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

List of Licenses under IS : IS 18880 : 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 18880 : 2024

List of Expired or Cancelled Licenses under IS : IS 18880 : 2024

List of laboratories for : IS 18880 : 2024

List of Amendement(s) for : IS 18880 : 2024

List of Gazette Document(s) for : IS 18880 : 2024

List of Corigenda Document(s) for : IS 18880 : 2024

List of Product Manuals & SIT