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IS Number/आईएस संख्या : IS/ISO 11137-1:2006
ISO 11137-1 : 2006

IS Title/आईएस शीर्षक : Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices (Withdrawn)

Superseded by IS/प्रतिस्थापित आईएस : None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 : 2

Aspect/पक्ष : Others

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष :

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 : Uroosa Warsi (SCIENTIST-C)

Other Details

Gazette Document : 1

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Classification details for: IS/ISO 11137 (Part 1) : 2006

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Cross Reference Details

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Cross Reference Details

Indian Standards Referred In IS IS/ISO 11137-1:2006
ISO 11137-1 : 2006
:

1	IS 12342 (Part 1):1988	Specification for raw seaweeds: Part 1 agarophytes	FAD 08

International Standards Referred In IS/ISO 11137-1:2006
ISO 11137-1 : 2006

1	ISO 10012 : 1 : 0 0
2	ISO 13485 : 2003
3	ISO 11737 : 1 : 0 0
4	ISO 11737 : 2 : 0 0

IS/ISO 11137-1:2006
ISO 11137-1 : 2006
is Referred in following Indian Standards :

1	IS/ISO 25539 : Part 1 : 2017	Cardiovascular implants - Endovascular devices: Part 1 endovascular prostheses (First Revision)	MHD 06
2	IS/ISO 15675 : 2016	Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters	MHD 06
3	IS/ISO 18241 : 2016	Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps	MHD 06
4	IS/ISO 18242 : 2016	Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps	MHD 06
5	IS/ISO 11137 : Part 3 : 2017	Sterilization of Health Care Products â€• Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control	MHD 12
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 06
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 11137 (Part 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
15	IS/ISO 27427 : 2013	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components	MHD 11
16	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
17	IS 17423 : 2020	Medical textiles – Coveralls for COVID 19 – Specification	TXD 36
18	IS 13009 : 2000	Contraceptive devices - Tubal ring - Specification (First Revision)	MHD 03
19	IS 17545 : 2021	White cement based polymeric putty	CHD 20
20	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
21	IS 16143 : Part 6 : 2021	Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision)	PCD 07
22	IS 17061 : 2019	Practice for dosimetry in radiation processing	CHD 30
23	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
24	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
25	IS/ISO/IEC 10779 : 2020	Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities	LITD 36
26	IS 13450 : Part 1 : 2018	Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision)	MHD 15
27	IS 3400 : Part 25 : 2022	METHODS OF TEST FOR RUBBER, VULCANIZED OR THERMOPLASTIC PART 25 DETERMINATION OF LOW-TEMPERATURE BRITTLENESS ( First Revision )	PCD 29
28	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	PCD 19
29	IS/ISO/TR 32220 : 2021	Sustainable finance ï¿½ Basic concepts and key initiatives	MSD 18
30	IS 16412 : 2023	Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors	MTD 33
31	IS 3025 : Part 29 : 2022	Methods of Sampling and Test (Physical and Chemical) for Water and Waste Water Part 29 Sulphide (Second Revision)	CHD 36
32	IS 17334 : 2019	Medical textiles – Surgical gowns and surgical drapes – Specification	TXD 36
33	IS/IEC 60115 : Part 1 : 2020	Fixed resistors for use in electronic equipment Part 1 Generic specification	LITD 05
34	IS/IEC 60384 : Part 4 : 2016	Fixed capacitors for use in electronic equipment Part 4 Sectional specification Fixed aluminium electrolytic capacitors with solid MnO2 and non-solid electrolyte Superseding IS 4317: 1983 and ISQC 300300 : 1992	LITD 05
35	IS/IEC 61058 : Part 1 : Sec 2 : 2016	SWITCHES FOR APPLIANCES PART 1 GENERAL REQUIREMENTS SECTION 2 PARTICULAR REQUIREMENTS FOR ELECTRONICS SWITCHES	ETD 14
36	IS 10714 : Part 2 : 2023	Technical product documentation (TPD) -- General principles of representation: Part 2 Basic conventions for lines	PGD 24
37	IS 18191 : 2023	Dentistry Vocabulary for Dental Implants Systems and Related Procedure	MHD 08
38	IS 12663 : Part 1 : 2023	Bulk Handling Equipment - Reclaimer - Data Sheet for Selection Part 1 Scraper Reclaimer (Rail Mounted) (First Revision)	MED 07

Classification Details

Certification	:
Group	:	Medical and Hospital Equipments
Sub Group	:	Health care facilities
Sub Sub Group	:	Sterilizers & incubators
Aspect	:	Others

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Basic Details/ मूल ब्यौरा

Other Details

Gazette Document : 1

Classification details for: IS/ISO 11137 (Part 1) : 2006

Cross Reference Details

Cross Reference Details

Classification Details