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Indian Standard Details

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Basic Details

IS Number :	IS 17697 : 2021 ISO 22794:2007
IS Title [Eng-Hn] :	Dentistry- Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
No of Revision :	0
No of Amendments :	0
Technical Department :	Medical Equipment and Hospital Planning Department
Technical Committee :	MHD 8 ( Dentistry )
Language :	English

Classification Details

Certification:
Group :	Medical and Hospital Equipments
Sub Group:	Dentistry instruments/equipment and accessories
Sub Sub Group :	Dental instruments
Aspects:	Product Specification
Ministry :
Short Commom Man's Title:
Itchs:	N/A
Degree of Equivalence:	Identical under dual numbering
Identical/Equivalent Standards:	ISO 22794:2007
Organisation :

Cross Referencing Details

Indian Standards Refered In IS IS 17697 : 2021 :

SNo	IS Number	Title	Technical Committee
1	IS 7348 : Part 1 : 2003	Dental vocabulary: Part 1 general and clinical terms	MHD 8
2	IS 7348 : Part 2 : 2003	Dental vocabulary: Part 2 dental materials (First Revision)	MHD 8
3	IS 7348 : Part 3 : 2003	Dental vocabulary: Part 3 dental instruments (Second Revision)	MHD 8
4	IS 7348 : Part 4 : 1994	Dental vocabulary: Part 4 dental equipment (Second Revision)	MHD 8
5	IS 7348 : Part 5 : 1994	Dental vocabulary: Part 5 terms associated with testing	MHD 8
6	IS/ISO 10993 : Part 1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process	MHD 19
7	IS/ISO 10993 : Part 17 : 2002	Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances	MHD 19
8	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
9	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
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 14155 : 2011	Clinical investigation of medical devices for human subjects - Good clinical practice	MHD 19
12	IS/ISO 14971 : 2007	Medical devices - Application of risk management to medical devices	MHD 14
13	IS/ISO 15223 : Part 1 : 2016	Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )	MHD 14
14	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

International Standards Refered In IS 17697 : 2021

Standard contains no Cross Referenced International Standard.

IS 17697 : 2021 is Refered in following Indian Standards :

SNo	IS Number	Title	Technical Committee
1	IS 17697 : 2021	Dentistry- Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file	MHD 8