Bureau of Indian Standards

The National Standards Body of India

Home About Standards Downloads Reports Standard Of The Week Standard Of The Month FAQ Contact Us

× About Services Overview Contact

�

Indian Standard Details

Print

Basic Details

IS Number :	IS 12572 (Part 13) : 1995 ISO 10993-3 Reviewed In : 2016
IS Title [Eng-Hn] :	Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
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:	None
Ministry :
Short Commom Man's Title:	Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Rep
Itchs:	N/A
Degree of Equivalence:	N/A
Identical/Equivalent Standards:	N/A

Cross Referencing Details

Indian Standards Refered In IS IS 12572 : Part 13 : 1995 :

SNo	IS Number	Title	Technical Committee
1	IS 12572 : Part 1 : 1994	Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests	MHD 19
2	IS 12572 : Part 2 : 1995	Biological evaluation of medical devices: Part 2 animal welfare requirements	MHD 19
3	IS 2 : 1960	Rules for Rounding off Numerical Values	MSD 3
4	IS 12572 : Part 3 : 1988	Guide for evaluation of medical devices for biological hazards: Part 3 method of testing by tissue implantation	MHD 19
5	IS 12572 : Part 4 : 2016	Biological evaluation of medical devices: Part 4 selection of tests for interaction with blood	MHD 19
6	IS 12572 : Part 5 : 1988	Guide for evaluation of medical devices for biological hazards: Part 5 method of test for intracutaneous reactivity of extracts from medical devices	MHD 19
7	IS 12572 : Part 6 : 1988	Guide for evaluation of medical devices for biological hazards: Part 6 method of test for systemic toxicity: assessment of pyrogenicity in rabbits of extracts from medical devices	MHD 19
8	IS 12572 : Part 7 : 1988	Guide for evaluation of medical devices for biological hazards: Part 7 methods of test for sensitization : assessment of potential of medical devices to produce delayed contact dermatitis	MHD 19
9	IS 12572 : Part 8 : 1988	Guide forevaluationofmedical devices for biological hazards: Part 8 method of test for skin irritation of extracts from medical devices	MHD 19
10	IS 12572 : Part 9 : 1988	Guide for evaluation of medical devices for biological hazards: Part 9 method of test for skin irritation by solid medical devices	MHD 19
11	IS 12572 : Part 10 : 1988	Guide for Evaluation of Medical Devices for Biological Hazards Part 10 Biological Testing and Evaluation of Dental Materials	MHD 19
12	IS 12572 : Part 11 : 1990	Guide for evaluation of medical devices for biological hazards: Part 11 method of test for eye irritation	MHD 19
13	IS 12572 : Part 14 : 1994	Biological Evaluation of Medical Devices - Part 14 : Selection of Tests for Interactions with Blood	MHD 19

International Standards Refered In IS 12572 : Part 13 : 1995

SNo	International Standard Number
1	ISO 10993 : 1 : 0 0
2	ISO 9001 : 0 : 0 0
3	ISO 9004 : 0 : 0 0
4	ISO 9966 : 0 : 0 0
5	ISO 7405 : 0 : 0 0

IS 12572 : Part 13 : 1995 is Refered in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.