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Indian Standard Details

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Basic Details
IS Number : IS 18446 (Part 1) : 2023
ISO 11140-1:2014
IS Title [Eng-Hn] : Sterilization of health care products Chemical indicators Part 1: General requirements
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 12 ( Hospital Equipment and Surgical Disposable Products )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Health care facilities
Sub Sub Group : Sterilizers & incubators
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under dual numbering
Identical/Equivalent Standards:ISO 11140-1:2014
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS 18446 : Part 1 : 2023 :
SNo IS Number Title Technical Committee
1
IS/ISO 8601 : Part 1 : 2019 Date and Time Representations For Information Interchange Part 1: Basic Rules MSD 5
2
IS/ISO 8601 : Part 2 : 2019 Date and Time Representations For Information Interchange Part 2: Extensions MSD 5
3
IS/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
4
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
5
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
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/ISO 11138 : Part 1 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements MHD 12
8
IS/ISO 11138 : Part 2 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes MHD 12
9
IS/ISO 11138 : Part 3 : 2017 Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes MHD 12
10
IS/ISO 11138 : Part 4 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes MHD 12
11
IS/ISO 11138 : Part 5 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes MHD 12
12
IS/ISO 11140 : Part 3 : 2007 Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test MHD 12
13
IS 18139 : Part 1 : 2023 Industrial Screen Specification Part 1 Woven Wire Cloth Screen CED 55
14
IS/ISO 8601 : Part 1 : 2019 Date and Time Representations For Information Interchange Part 1: Basic Rules MSD 5
15
IS/ISO 8601 : Part 2 : 2019 Date and Time Representations For Information Interchange Part 2: Extensions MSD 5
16
IS/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
17
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
18
IS/ISO 11137 : Part 2 : 2013 Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose MHD 12
19
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
20
IS/ISO 11138 : Part 1 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements MHD 12
21
IS/ISO 11138 : Part 2 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes MHD 12
22
IS/ISO 11138 : Part 3 : 2017 Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes MHD 12
23
IS/ISO 11138 : Part 4 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes MHD 12
24
IS/ISO 11138 : Part 5 : 2017 Sterilization of Health Care Products ― Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes MHD 12
25
IS/ISO 11140 : Part 3 : 2007 Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test MHD 12
26
IS 18139 : Part 1 : 2023 Industrial Screen Specification Part 1 Woven Wire Cloth Screen CED 55
International Standards Refered In IS 18446 : Part 1 : 2023 Standard contains no Cross Referenced International Standard.
IS 18446 : Part 1 : 2023 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS 5550 : 2023 BURFI � SPECIFICATION (First Revision of IS 5550) FAD 19
2 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
3 IS/IEC 61970 : Part 301 : 2022 Energy management system application program interface EMS-API Part 301: Common information model CIM base LITD 10