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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS/ISO 11135 : 2014
ISO 11135 : 2014

IS Title/आईएस शीर्षक : Sterilization of health - Care products - Ethylene oxide - 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 single numbering

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : 1

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 : 1

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Gazette Document : 2

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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 11135 : 2014
ISO 11135 : 2014
:

Details could not be found.

International Standards Referred In IS/ISO 11135 : 2014
ISO 11135 : 2014

Standard contains no Cross Referenced International Standard.

IS/ISO 11135 : 2014
ISO 11135 : 2014
is Referred in following Indian Standards :

1	IS/ISO 25539 : Part 1 : 2017	Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)	MHD 6
2	IS/ISO 15675 : 2016	Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters	MHD 6
3	IS/ISO 18241 : 2016	Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps	MHD 6
4	IS/ISO 11138 : Part 1 : 2017	Sterilization of Health Care Products â€• Biological Indicators Part 1 General Requirements	MHD 12
5	IS 17334 : 2019	Medical textiles – Surgical gowns and surgical drapes – Specification	TXD 36
6	IS 17348 : 2020	Medical textiles – Adhesive incise drape – Specification	TXD 36
7	IS 17350 : 2020	Medical textiles – Abdominal binder – Specification	TXD 36
8	IS 17351 : 2020	Medical textiles – Dressing, shell compressed – Specification	TXD 36
9	IS 17352 : 2020	Medical textiles – Foam dressing – Specification	TXD 36
10	IS/ISO 5840 : Part 3 : 2013	Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques	MHD 6
11	IS 17410 : 2020	Medical Textiles â€” Bio-Protective Coverall â€” Specification	TXD 36
12	IS 17506 : 2020	Medical Textiles - Hydrocolloid Dressing - Specification	TXD 36
13	IS 12725 : 2021	Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision )	PGD 36
14	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
15	IS/ISO 11607 : Part 1 : 2019	Packaging for terminally sterilized medical devices â€” Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision	MHD 12
16	IS 17423 : 2020	Medical textiles – Coveralls for COVID 19 – Specification	TXD 36
17	IS 17545 : 2021	White cement based polymeric putty	CHD 20
18	IS 3025 : Part 71 : 2021	Methods of Sampling and Test (Physical and Chemical) for Water and Wastewater Part 71 Determination of Dissolved Cations Using Ion Chromatography	CHD 36
19	IS 16143 : Part 6 : 2021	Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision)	PCD 7
20	IS 729 : 2021	DRAWER LOCKS CUPBOARD LOCKS AND BOX LOCKS - SPECIFICATION	MED 33
21	IS 101 : Part 2 : Sec 4 : 2022	Methods of sampling and test for paints varnishes and related products: Part 2 test on liquid paints chemical examination : Sec 4 determination of volatile organic compound voc and or semi volatile organic compounds svoc content gas-chromatographic (First Revision)	CHD 20
22	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
23	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
24	IS 3400 : Part 25 : 2022	METHODS OF TEST FOR RUBBER, VULCANIZED OR THERMOPLASTIC PART 25 DETERMINATION OF LOW-TEMPERATURE BRITTLENESS ( First Revision )	PCD 29
25	IS 4707 : Part 4 : 2022	Classification Of Cosmetic Raw Materials And Adjuncts -List of UV Filters Allowed In Cosmetics With Restriction-IS 4707 Part 4
26	IS 16412 : 2023	Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors	MTD 33

Classification Details

Group	:	N/A
Sub Group	:	N/A
Sub Sub Group	:	N/A
Aspect	:	Process Specification
Certification	:
Relevant Ministries	:	No Associated Ministry
Sustainable development Goals :
Short Commom Man's Title	:	Sterilization of health - Care products - Ethylene oxide
ITC-HS Code	:	N/A
Degree of Equivalence	:	Identical under single numbering
Identical/Equivalent International Standard(s)	:	ISO 11135 : 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/ISO 11135 : 2014

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 : 1

Gazette Document : 2

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 11135 : 2014

List of Expired or Cancelled Licenses under IS : IS/ISO 11135 : 2014

List of laboratories for : IS/ISO 11135 : 2014

List of Amendement(s) for : IS/ISO 11135 : 2014

List of Gazette Document(s) for : IS/ISO 11135 : 2014

List of Corigenda Document(s) for : IS/ISO 11135 : 2014

List of Product Manuals & SIT