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Indian Standard Details

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Basic Details
IS Number : IS/ISO 11607-2 : 2006
IS Title [Eng-Hn] : Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes
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: Medical and Hospital Equipments
Sub Sub Group : Allied hospital equipment
Aspects: Code of Practice
Certification:
Ministry : Ministry of Health and Family Welfare
Short Commom Man's Title:
Itchs:
Degree of Equivalence: Identical under single numbering
Identical/Equivalent Standards:ISO 11607-2:2019
Organisation :

Cross Referencing Details
Indian Standards Refered In IS IS/ISO 11607 : Part 2 : 2006 :
SNo IS Number Title Technical Committee
1
IS 7155 : Part 7 : 1990 Code of recommended practice for conveyor safety: Part 7 inspection and maintenance (First Revision) MED 6
International Standards Refered In IS/ISO 11607 : Part 2 : 2006 Standard contains no Cross Referenced International Standard.
IS/ISO 11607 : Part 2 : 2006 is Refered in following Indian Standards :
SNo IS Number Title Technical Committee
1 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
2 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
3 IS 17334 : 2019 Medical textiles – Surgical gowns and surgical drapes – Specification TXD 36
4 IS 17348 : 2020 Medical textiles – Adhesive incise drape – Specification TXD 36
5 IS 17350 : 2020 Medical textiles – Abdominal binder – Specification TXD 36
6 IS 17351 : 2020 Medical textiles – Dressing, shell compressed – Specification TXD 36
7 IS/ISO 5840 : Part 3 : 2013 Cardiovascular Implants Cardiac Valve Prostheses Part 3 Heart Valve Substitutes Implanted by Trans-Catheter Techniques MHD 6
8 IS 17410 : 2020 Medical Textiles — Bio-Protective Coverall — Specification TXD 36
9 IS 17506 : 2020 Medical Textiles - Hydrocolloid Dressing - Specification TXD 36
10 IS/ISO 11607 : Part 2 : 2006 Packaging for terminally sterilized medical devices: Part 2 validation requirements for forming, sealing and assembly processes MHD 12
11 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
12 IS/IEC 60479 : Part 1 : 2018 Effects of current on human beings and livestock - Part 1: General Aspects ETD 20
13 IS 17423 : 2020 Medical textiles – Coveralls for COVID 19 – Specification TXD 36
14 IS 17545 : 2021 White cement based polymeric putty CHD 20