Indian Standard Details

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

IS Title [Eng-Hn] : Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices
No of Revision : 0
No of Amendments : 1
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 12 ( Hospital Equipment and Surgical Disposable Products )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Sterilizers & incubators
Aspects: Others
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title: Sterilization of health care products
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 11137-1 : 2006
Organisation :

Indian Standards Refered In IS IS/ISO 11137 : Part 1 : 2006 :
SNo IS Number Title Technical Committee
1
IS 12342 : Part 1 : 1988 Specification for raw seaweeds: Part 1 agarophytes FAD 8
International Standards Refered In IS/ISO 11137 : Part 1 : 2006 Standard contains no Cross Referenced International Standard.
IS/ISO 11137 : Part 1 : 2006 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
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 18242 : 2016 Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps MHD 6
5 IS 17334 : 2019 Medical textiles – Surgical gowns and surgical drapes – Specification TXD 36
6 IS/ISO 11137 : Part 3 : 2017 Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control MHD 12
7 IS 17348 : 2020 Medical textiles – Adhesive incise drape – Specification TXD 36
8 IS 17350 : 2020 Medical textiles – Abdominal binder – Specification TXD 36
9 IS 17351 : 2020 Medical textiles – Dressing, shell compressed – Specification TXD 36
10 IS 17352 : 2020 Medical textiles – Foam dressing – Specification TXD 36
11 IS/ISO 5840 : Part 3 : 2013 Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques MHD 6
12 IS 17410 : 2020 Medical Textiles — Bio-Protective Coverall — Specification TXD 36
13 IS 17506 : 2020 Medical Textiles - Hydrocolloid Dressing - Specification TXD 36
14 IS 12725 : 2021 Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision ) PGD 36
15 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
16 IS/ISO 27427 : 2013 Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components MHD 11
17 IS/ISO 11607 : Part 1 : 2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision MHD 12
18 IS 17423 : 2020 Medical textiles – Coveralls for COVID 19 – Specification TXD 36
19 IS 13009 : 2000 Contraceptive devices - Tubal ring - Specification (First Revision) MHD 3
20 IS 17545 : 2021 White cement based polymeric putty CHD 20
21 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
22 IS 16143 : Part 6 : 2021 Hard coal and coke - Mechanical sampling : Part 6 coke - preparation of test samples (First Revision) PCD 7
23 IS 17061 : 2019 Practice for dosimetry in radiation processing CHD 30
24 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
25 IS/ISO/IEC 10779 : 2020 Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities LITD 36
26 IS/ISO/IEC 10779 : 2020 Information technology Office equipment Accessibility guidelines for older persons and persons with disabilities LITD 36
27 IS 13450 : Part 1 : 2018 Medical electrical equipment: Part 1 general requirements for basic safety and essential performance (Second Revision) MHD 15
28 IS 3400 : Part 25 : 2022 METHODS OF TEST FOR RUBBER, VULCANIZED OR THERMOPLASTIC PART 25 DETERMINATION OF LOW-TEMPERATURE BRITTLENESS ( First Revision ) PCD 29
29 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
30 IS/ISO/TR 32220 : 2021 Sustainable finance � Basic concepts and key initiatives MSD 18
31 IS 16412 : 2023 Nanotechnologies Characterization of multiwall carbon nanotubes Mesoscopic shape factors MTD 33