Indian_standards - BIS Connect

Basic Details/ मूल ब्यौरा

IS Number/आईएस संख्या : IS 12572 (Part 13) : 1995
ISO 10993-3
Reviewed In : 2016

IS Title/आईएस शीर्षक : Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity (Withdrawn)

Superseded by IS/प्रतिस्थापित आईएस : IS/ISO 10993-3 : 2014

Degree of Equivalence/समतुल्यता स्तर : Indigenous

Number of Revisions/पुनरीक्षणों की संख्या : New Standard

Number of Amendments/संशोधनों की संख्या : No amendment issued

Aspect/पक्ष : Methods of tests

Language/भाषा : English

Reaffirmation Year/पुनर्पुष्टि वर्ष : February, 2016

Technical Department/तकनीकी विभाग : MHD (Medical Equipment and Hospital Planning Department)

Technical Committee/तकनीकी समिति : MHD 19 (In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices Sectional Committee)

Member Secretary/सदस्य सचिव : Ms. NAGAVARSHINI M (SCIENTIST-C)

Other Details

Gazette Document : 0

Classification details for: IS 12572 : Part 13 : 1995

Click to view

Cross Reference Details

Click to view

Cross Reference Details

Indian Standards Referred In IS IS 12572 (Part 13) : 1995
ISO 10993-3
Reviewed In : 2016 :

1	IS 12572 (Part 1) : 1994 ISO 10993-1 Reviewed In : 2016	Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests	MHD 19
2	IS 12572 (Part 2) : 1995 ISO 10993-2 Reviewed In : 2016	Biological evaluation of medical devices: Part 2 animal welfare requirements	MHD 19
3	IS 2 : 2022	Rules for Rounding off Numerical Values	MSD 3
4	IS 12572 (Part 3) : 1988 Reviewed In : 2016	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 ISO 10993-4 : 2002	Biological evaluation of medical devices: Part 4 selection of tests for interaction with blood	MHD 19
6	IS 12572 (Part 5) : 1988 Reviewed In : 2016	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 Reviewed In : 2016	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 Reviewed In : 2016	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 Reviewed In : 2016	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 Reviewed In : 2016	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 Reviewed In : 2016	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 Reviewed In : 2016	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 ISO 10993-4 Reviewed In : 2016	Biological Evaluation of Medical Devices - Part 14 : Selection of Tests for Interactions with Blood	MHD 19

International Standards Referred In IS 12572 (Part 13) : 1995
ISO 10993-3
Reviewed In : 2016

1	ISO 10993 : 1 : 0 0
2	ISO 10993 : 2 : 0 0
3	ISO 10993 : 3 : 0 0
4	ISO 10993 : 0 : 0 0
5	ISO 10993 : 12 : 0 0

IS 12572 (Part 13) : 1995
ISO 10993-3
Reviewed In : 2016 is Referred in following Indian Standards :

Standard contains no Cross Referenced Indian Standard.

Classification Details

Group	:	Medical and Hospital Equipments
Sub Group	:	Clinical, pathological, anaesthetic and respiratory equipments and systems
Sub Sub Group	:	Biological tests
Aspect	:	Methods of tests
Certification	:	None
Relevant Ministries	:
Sustainable development Goals :
Short Commom Man's Title	:	Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Rep
ITC-HS Code	:	N/A
Degree of Equivalence	:
Identical/Equivalent International Standard(s)	:
Harmonized with	:

ID	Mailing list	Download
1	Committee members email list	Download
3	Additional mailing list	Download

List of Licenses under IS : IS 12572 : Part 13 : 1995

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

ID	Licence No.	Firm Name & Address	District	State	Validity Date	Status	Variety	Brand Name	Scale

Know your standards

Basic Details/ मूल ब्यौरा

Other Details

Gazette Document : 0

Classification details for: IS 12572 : Part 13 : 1995

Cross Reference Details

Cross Reference Details

Classification Details

Email Ids

List of Licenses under IS : IS 12572 : Part 13 : 1995

List of Expired or Cancelled Licenses under IS : IS 12572 : Part 13 : 1995

List of laboratories for : IS 12572 : Part 13 : 1995

List of Amendement(s) for : IS 12572 : Part 13 : 1995

List of Gazette Document(s) for : IS 12572 : Part 13 : 1995

List of Corigenda Document(s) for : IS 12572 : Part 13 : 1995

List of Product Manuals & SIT