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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017

IS Title/आईएस शीर्षक : Sterilization of Health Care Products â€• Biological Indicators Part 1 General Requirements

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Identical under single 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/ISO 11138-1 : 2017
ISO 11138-1 : 2017
:

1	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

International Standards Referred In IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017

1	ISO 11737 : 1 : 2006
2	ISO 14937 : 2009
3	ISO 17665 : 1 : 2006
4	ISO 18472 : 2006

IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017
is Referred in following Indian Standards :

1	IS/ISO 6016 : 2008	Earth-Moving Machinery â€” Methods of Measuring the Masses of Whole Machines, their Equipment and Components	MED 7
2	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
3	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
4	IS 5550 : 2023	BURFI ï¿½ SPECIFICATION (First Revision of IS 5550)	FAD 19
5	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
6	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	:	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 single numbering
Identical/Equivalent International Standard(s)	:	ISO 11138-1 : 2017
Harmonized with	:

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

List of Licenses under IS : IS/ISO 11138 : Part 1 : 2017

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

Know your standards

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/ISO 11138 : Part 1 : 2017

List of Expired or Cancelled Licenses under IS : IS/ISO 11138 : Part 1 : 2017

List of laboratories for : IS/ISO 11138 : Part 1 : 2017

List of Amendement(s) for : IS/ISO 11138 : Part 1 : 2017

List of Gazette Document(s) for : IS/ISO 11138 : Part 1 : 2017

List of Corigenda Document(s) for : IS/ISO 11138 : Part 1 : 2017

List of Product Manuals & SIT