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Indian Standard Details

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Basic Details
IS Number : IS/ISO 10993-7 : 2018
ISO 10993-7 : 2008

IS Title [Eng-Hn] : Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
No of Revision : 0
No of Amendments : 0
Technical Department : Medical Equipment and Hospital Planning Department
Technical Committee : MHD 19 ( In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices )
Language : English

Classification Details
Group : Medical and Hospital Equipments
Sub Group: Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group : Biological tests
Aspects: Methods of tests
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs: N/A
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 10993-7:2008
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 10993 : Part 7 : 2018 :
SNo IS Number Title Technical Committee
1
IS 10370 : Part 3 : 1982 Dimensions of mounting accessories of pot cores for wired circuits: Part 3 for pot cores of size 18 x 14 mm LITD 24
2
IS 10373 : 1982 Specification for plastic boxes for safety matches CHD 26
3
IS 11140 : 1984 Specification for footrest assembly for mopeds TED 6
4
IS 1200 : Part 28 : 1992 Method of building and civil engineering works: Part 28 sound insulation work CED 44
5
IS 12287 : 1988 Specification for consolidometer for determination of consolidation properties CED 43
International Standards Refered In IS/ISO 10993 : Part 7 : 2018 Standard contains no Cross Referenced International Standard.
IS/ISO 10993 : Part 7 : 2018 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
2 IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals 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 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
5 IS/ISO 10993 : Part 7 : 2018 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals MHD 19
6 IS/ISO 15223 : Part 2 : 2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation MHD 14
7 IS/ISO 15674 : 2016 Cardiovascular implants and artificial organs - Hard - Shell cardiotomy/venous reservoir systems (With/without Filter) and soft venous reservoir bags (Second Revision) MHD 6
8 IS/ISO 7198 : 2016 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches MHD 6
9 IS/ISO 12417 : Part 1 : 2015 Cardiovascular Implants and Extracorporeal Systems Vascular Device-Drug Combination Products Part 1 General Requirements MHD 6
10 IS/ISO 15675 : 2016 Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass Systems Arterial Blood Line Filters MHD 6
11 IS/ISO 18241 : 2016 Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Venous Bubble Traps MHD 6
12 IS/ISO 18242 : 2016 Cardiovascular Implants and Extracorporeal Systems Centrifugal Blood Pumps MHD 6
13 IS 17334 : 2019 Medical textiles – Surgical gowns and surgical drapes – Specification TXD 36
14 IS 17348 : 2020 Medical textiles – Adhesive incise drape – Specification TXD 36
15 IS 17350 : 2020 Medical textiles – Abdominal binder – Specification TXD 36
16 IS 17351 : 2020 Medical textiles – Dressing, shell compressed – Specification TXD 36
17 IS 17352 : 2020 Medical textiles – Foam dressing – Specification TXD 36
18 IS/ISO 8637 : Part 1 : 2017 Extracorporeal Systems for Blood Purification Part 1 Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators MHD 6
19 IS/ISO 8637 : Part 2 : 2018 Extracorporeal Systems for Blood Purification Part 2 Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters MHD 6
20 IS/ISO 8637 : Part 3 : 2018 Extracorporeal Systems for Blood Purification Part 3 Plasmafilters MHD 6
21 IS 17410 : 2020 Medical Textiles — Bio-Protective Coverall — Specification TXD 36
22 IS 17506 : 2020 Medical Textiles - Hydrocolloid Dressing - Specification TXD 36
23 IS 15490 : 2004 Cylinders for On-Board Storage of Compressed Natural Gas As a Fuel for Automotive Vehicles MED 16
24 IS 12725 : 2021 Pneumatic Fluid Power - General Rules and Safety Requirements for Systems and their Components ( Second Revision ) PGD 36
25 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
26 IS 17423 : 2020 Medical textiles – Coveralls for COVID 19 – Specification TXD 36
27 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
28 IS/IEC 60794 : Part 4 : Sec 20 : 2018 Optical Fibre Cables Part 4 Sectional specification Section 20 Aerial optical cables along electrical power lines Family specification for ADSS all dielectric self-supported optical cables LITD 11
29 IS 15354 : Part 1 : 2018 Single - Use medical examination gloves: Part 1 specification for gloves made from rubber latex or rubber solution (First Revision) MHD 12
30 IS 3400 : Part 25 : 2022 METHODS OF TEST FOR RUBBER, VULCANIZED OR THERMOPLASTIC PART 25 DETERMINATION OF LOW-TEMPERATURE BRITTLENESS ( First Revision ) PCD 29
31 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
32 IS 5550 : 2023 BURFI � SPECIFICATION (First Revision of IS 5550) FAD 19