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Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 17348:2020

IS Title/आईएस शीर्षक : Medical textiles – Adhesive incise drape – Specification

Superseding IS/सुपरसीडिंग आईएस : None

Degree of Equivalence/समतुल्यता स्तर : Indigenous

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 :

Technical Department/तकनीकी विभाग : TXD (Textiles Department)

Technical Committee/तकनीकी समिति : TXD 36 (Technical Textiles for Medtech Applications Sectional Committee)

Member Secretary/सदस्य सचिव : Amit Kumar Pandey

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 17348:2020

:

1	IS 11137 (Part 2):2012 IEC 60812: 2006	Analysis techniques for system reliABility: Part 2 procedure for failure mode and effects analysis (Fmea) (First Revision)	LITD 02
2	IS 14944:2020	Surgical Dressings - Methods of Test ( first revision )	TXD 36
3	IS 4905:2015 ISO 24153 : 2009	Random sampling and randomization procedures (First Revision)	MSD 03
4	IS 16546:2016 ISO 16603 : 2004	Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood	TXD 36
5	IS/ISO 10993-5:2009 ISO 10993-5 : 2009	Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity	MHD 19
6	IS/ISO 10993-10:2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization	MHD 19
7	IS/ISO 11607:2019 ISO 11607-2:2019	Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes	MHD 12
8	IS/ISO 11607:2019 ISO 11607-1:2019	Packaging for terminally sterilized medical devices: Part 1 requirements for materials, sterile barrier systems and packaging systems	MHD 12
9	IS/ISO 10993-7:2018 ISO 10993-7 : 2008	Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals	MHD 19
10	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
11	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 17348:2020

1	ISO 811 : 2018
2	ISO 11092 : 2014

IS 17348:2020

is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Classification Details

Certification	:
Group	:	Textile, Textile Products and Machinery
Sub Group	:	Textile for special use
Sub Sub Group	:	Medical textiles
Aspect	:	Product Specification

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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