Indian Standard Details

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IS Number : IS 18974:2025

IS Title [Eng-Hn] : Cardiovascular Implants and Artificial Organs � Cannulae for Extracorporeal Circulation (ISO 18193 : 2021, MOD)
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 6 ( Medical and Surgical Cardiology Equipment )
Language : English

Group : Medical and Hospital Equipments
Sub Group: Implants
Sub Sub Group : Cardiovascular surgery instrument and implants
Aspects: Product Specification
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Modified/Technically Equivalent
Identical/Equivalent Standards:ISO 18193:2021
Organisation :

Indian Standards Refered In IS IS 18974 : 2025 :
SNo IS Number Title Technical Committee
1
IS 17932 : Part 1 : 2023 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD) MHD 19
2
IS/ISO 10993 : Part 4 : 2017 Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood MHD 19
3
IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
4
IS/ISO 10993 : Part 11 : 2017 Biological evaluation of medical devices Part 11 Tests for systemic toxicity MHD 19
5
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
6
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
7
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
8
IS/ISO 11607 : Part 2 : 2019 Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) MHD 12
9
IS/ISO 14937 : 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices MHD 12
10
IS 18319 : Part 1 : 2023 Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices MHD 12
11
IS/ISO 80369 : Part 7 : 2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications MHD 12
International Standards Refered In IS 18974 : 2025 Standard contains no Cross Referenced International Standard.
IS 18974 : 2025 is Refered in following Indian Standards : Standard contains no Cross Referenced Indian Standard.