Revised Standards    New Standards

Standards List

S.No IS Number IS Title Category Reaffirmation Year Scope
1 IS 12572 : Part 1 : 1994/ISO 10993-1
(1 Revision)
Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests Code of Practice 2016, Feb Buy
2 IS 12572 : Part 11 : 1990
Guide for evaluation of medical devices for biological hazards: Part 11 method of test for eye irritation Methods of tests 2016, Feb Download
3 IS 12572 : Part 2 : 1995/ISO 10993-2
Biological evaluation of medical devices: Part 2 animal welfare requirements Others 2016, Feb Buy
4 IS 12572 : Part 3 : 1988
Guide for evaluation of medical devices for biological hazards: Part 3 method of testing by tissue implantation Methods of tests 2016, Feb Download
5 IS 12572 : Part 4 : 2016/ISO 10993-4 : 2002
(1 Revision)
Biological evaluation of medical devices: Part 4 selection of tests for interaction with blood Methods of tests 0 Buy
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 Methods of tests 2016, Feb Download
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 Methods of tests 2016, Feb Download
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 Methods of tests 2016, Feb Download
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 Methods of tests 2016, Feb Download
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 Methods of tests 2016, Feb Download
11 IS/IEC 61010 : Part 1 : 2010
Safety requirements for electrical equipment for measurement, control, and laboratory use: Part 1 general requirements Saftey Standard 0 Download
12 IS/IEC 61010 : Part 2-081 : 2009/IEC 61010 : Part 2-081 : 2009
Safety requirements for electrical equipment for measurement, control and laboratory use: Part 2 - 081 particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes Saftey Standard 0 Buy
13 IS/IEC/TS 10993 : Part 19 : 2006/ISO/TS 109993-19 : 2006
Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials 0 Buy
14 IS/ISO 10993 : Part 1 : 2009/ISO 10993-1 : 2009
Biological evaluation of medical devices: Part 1 evaluation and testing within a risk management process Methods of tests 0 Buy
15 IS/ISO 10993 : Part 10 : 2010/ISO 10993-10:2010
Biological evaluation of medical devices: Part 10 tests for irritation and skin sensitization Methods of tests 0 Buy
16 IS/ISO 10993 : Part 11 : 2017/ISO 10993-11 : 2017
Biological evaluation of medical devices: Part 11 tests for systemic toxicity Methods of tests 0 Buy
17 IS/ISO 10993 : Part 15 : 2000/ISO 10993-15:2000
Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys Methods of tests 0 Buy
18 IS/ISO 10993 : Part 16 : 2017/ISO 10993-16 : 2017
Biological evaluation of medical devices: Part 16 toxicokinetic study design for degradation products and leachables Others 0 Buy
19 IS/ISO 10993 : Part 17 : 2002/ISO 10993-17 : 2002
Biological evaluation of medical devices: Part 17 establishment of allowable limits for leachable substances Methods of tests 0 Buy
20 IS/ISO 10993 : Part 3 : 2014/ISO 10993-3 : 2014
Biological evaluation of medical devices: Part 3 tests for genotoxicity, carcinogenicity and reproductive toxicity (First Revision) Methods of tests 0 Buy
21 IS/ISO 10993 : Part 4 : 2017/ISO 10993-4 : 2017
Biological evaluation of medical devices: Part 4 selection of tests for interactions with blood Methods of tests 0 Buy
22 IS/ISO 10993 : Part 5 : 2009/ISO/TS 10993-20:2006
Biological evaluation of medical devices: Part 5 tests for in vitro cytotoxicity Methods of tests 0 Buy
23 IS/ISO 10993 : Part 6 : 2016/ISO 10993-6 : 2016
Biological evaluation of medical devices: Part 6 tests for local effects after implantation Methods of tests 0 Buy
24 IS/ISO 10993 : Part 7 : 2018/ISO 10993-7:2008
Biological evaluation of medical devices: Part 7 ethylene oxide sterilization residuals Methods of tests 0 Buy
25 IS/ISO 10993 : Part 9 : 2009/ISO 10993-9:2009
Biological evaluation of medical devices: Part 9 framework for identification and quantification of potential degradation products Methods of tests 0 Buy
26 IS/ISO 13022 : 2012/ISO 13022:2012
Medical products containing viable human cells - Application of risk management and requirements for processing practices Methods of tests 0 Buy
27 IS/ISO 14155 : 2011/ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice Others 0 Buy
28 IS/ISO 22442 : Part 1 : 2015/ISO 22442-1 : 2015
Medical devices utilizing animal tissues and their derivatives: Part 1 application of risk management Others 0 Buy
29 IS/ISO 22442 : Part 2 : 2015/ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives: Part 2 controls on sourcing, collection and handling Methods of tests 0 Buy
30 IS/ISO 7405 : 2008/ISO 7405:2008
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry Methods of tests 0 Buy
31 IS/ISO/TR 10993 : Part 22 : 2017/ISO/TR 10993-22:2017
Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials Others 0 Buy
32 IS/ISO/TR 15499 : 2016/ISO/TR 15499 : 2016
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process Methods of tests 0 Buy
33 IS/ISO/TR 22442 : Part 4 : 2010/ISO/TR 22442-4:2010
Medical Devices Utilizing Animal Tissues and their Derivatives Part 4 Principles for Elimination and/or Inactivation of Transmissble Spongifrom Encephalopathy (TSE) Agents and Validation Assays for those Processes Methods of tests 0 Buy
34 IS/ISO/TR 37137 : 2014/ISO/TR 37137:2014
Cardiovascular Biological Evaluation of Medical Devices — Guidance For Absorbable Implants Methods of tests 0 Buy