Programme of work

BUREAU OF INDIAN STANDARDS

Medical Equipment and Hospital Planning Department

Programme of Work

MHD19 : In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices

Scope : To formulate Indian Standards on: a) In-vitro Diagnostic kits, reagents, analyzers and associated software b) Biological and clinical evaluation of medical and dental materials, devices, implants together with standardization of biological test methods applicable to those materials and devices, and c) Good clinical practice principles to clinical investigations in humans of those devices
Liaison :

ISO/TC 194 - Biological and clinical evaluation of medical devices - Participating (P)
ISO TC 194/WG 14 - Material characterization
ISO TC 194/WG 5 - Cytotoxicity
ISO TC 194/WG 8 - Irritation, sensitization
ISO TC 194/WG 9 - Effects on blood
ISO TC 212/WG 3 - In vitro diagnostic products
ISO TC 212/WG 4 - Microbiology and molecular diagnostics

Published Standards

SI. No.	IS No.	Title	Reaffirmation Details	No. of Amendments	Degree of Equivalence
1.	IS/ISO 10993-2 : 2006 ISO 10993-2:2006	Biological Evaluation of Medical Devices Part 2 Animal Welfare Requirements (First Revision)		-	Identical under single numbering
2.	IS/ISO 10993-3 : 2014 ISO 10993-3 : 2014	Biological evaluation of medical devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive toxicity (First Revision)		-	Identical under single numbering
3.	IS/ISO 10993-4 : 2017 ISO 10993-4 : 2017	Biological evaluation of medical devices Part 4 Selection of tests for interactions with blood		-	Identical under single numbering
4.	IS/ISO 10993-5 : 2009 ISO 10993-5 : 2009	Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity		-	Identical under single numbering
5.	IS/ISO 10993-6 : 2016 ISO 10993-6 : 2016	Biological evaluation of medical devices Part 6 Tests for local effects after implantation		-	Identical under single numbering
6.	IS/ISO 10993-7 : 2018 ISO 10993-7 : 2008	Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals		-	Identical under single numbering
7.	IS/ISO 10993-9 : 2009 ISO 10993-9 : 2009	Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products		-	Identical under single numbering
8.	IS/ISO 10993-11 : 2017 ISO 10993-11 : 2017	Biological evaluation of medical devices Part 11 Tests for systemic toxicity		-	Identical under single numbering
9.	IS/ISO 10993-12 : 2021 10993: Part 12	Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials		-	Identical under single numbering
10.	IS/ISO 10993-13 : 2010 ISO 10993-13:2010	Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices		-	Identical under single numbering
11.	IS/ISO 10993-14 : 2001 ISO 10993-14:2001	Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics		-	Identical under single numbering
12.	IS/ISO 10993-15 : 2000 ISO 10993-15 : 2000	Biological evaluation of medical devices: Part 15 identification and quantification of degradation products from metals and alloys		-	Identical under single numbering
13.	IS/ISO 10993-16 : 2017 ISO 10993-16 : 2017	Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables		-	Identical under single numbering
14.	IS/ISO 10993-17 : 2002 ISO 10993-17 : 2002	Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances		-	Identical under single numbering
15.	IS/ISO 10993-18 : 2020 10993: Part 18	Biological evaluation of medical devices Part 18 Chemical characterization of medical device materials within a risk management process		-	Identical under single numbering
16.	IS/IEC/TS 10993-19 : 2006 ISO/TS 109993-19 : 2006	Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials		-	Identical under single numbering
17.	IS/ISO/TS 10993-20 : 2006 ISO/TS 10993-20:2006	Biological evaluation of medical devices Part 20 Principles and methods for immunotoxicology testing of medical devices		-	Identical under single numbering
18.	IS/ISO/TR 10993-22 : 2017 ISO/TR 10993-22 : 2017	Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials		-	Identical under single numbering
19.	IS/ISO 13022 : 2012 ISO 13022 : 2012	Medical products containing viable human cells - Application of risk management and requirements for processing practices		-	Identical under single numbering
20.	IS/ISO 14155 : 2020 ISO 14155: 2020	Clinical investigation of medical devices for human subjects - Good clinical practice		-	Identical under single numbering
21.	IS/ISO 15197 : 2013 ISO 15197 : 2013 Reviewed In : 2020	In vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring System for Self-Testing in Managing Diabetes Mellitus (First Revision)	January, 2020	-	Identical under single numbering
22.	IS/ISO 15198 : 2004 ISO 15198 : 2004	Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer		-	Identical under single numbering
23.	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		-	Identical under single numbering
24.	IS/ISO 17511 : 2020 ISO 17511 : 2020	In Vitro Diagnostic Medical Devices - Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials and Human Samples		-	Identical under single numbering
25.	IS 17713 : 2023	In-Vitro Diagnostic Devices - ELISA Plate Reader		-	Indigenous
26.	IS 17714 : 2023	In-Vitro Diagnostic Devices - Automated ELISA Processor		-	Indigenous
27.	IS 17715 : 2023	In-vitro Diagnostic Device - ELISA Plate Washer		-	Indigenous
28.	IS 17717 (Part 1) : 2023	In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer		-	Indigenous
29.	IS 17717 (Part 2) : 2023	In-Vitro Diagnostic (IVD) Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer		-	Indigenous
30.	IS 17718 : 2022	Performance testing of In-vitro Diagnostics IVD Reagent Kit alpha - Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents/ Kits		-	Indigenous
31.	IS 17719 : 2023	In-Vitro Diagnostic (IVD) Medical Device - Automatic Slide Staining Instrument		-	Indigenous
32.	IS 17720 : 2023	In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System		-	Indigenous
33.	IS 17724 (Part 1) : 2023	Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1 General Requirements (IEC 61010-1: 2010 + AMD1:2016 + COR1:2019, MOD)		-	Modified/Technically Equivalent
34.	IS 17724 (Part 2) : 2023 IEC 61010-2-051: 2018	Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 2 Particular Requirements for Laboratory Equipment used in Mixing and Stirring		-	Identical under dual numbering
35.	IS 17724 (Part 3) : 2024	Safety Requirements for Electrical Equipment for Measurement, Control, And Laboratory Use Part 3 Particular Requirements of Automatic and Semi-Automatic Laboratory Equipment used for Analysis and Other Purposes		-	Modified/Technically Equivalent
36.	IS 17724 (Part 4) : 2023	Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 4 Particular Requirements for In-Vitro Diagnostic (IVD) Medical Equipment (IEC 61010-2-101 : 2018, MOD)		-	Modified/Technically Equivalent
37.	IS 17784 (Part 1) : 2023	Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements Part 1 General Requirements (IEC 61326-1: 2020, MOD)		-	Modified/Technically Equivalent
38.	IS 17784 (Part 2) : 2023	Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2 Particular requirements for In-vitro diagnostic (IVD) medical equipment (IEC 61326-2-6 : 2020, MOD)		-	Modified/Technically Equivalent
39.	IS 17932 (Part 1) : 2023	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (ISO 10993-1 : 2018, MOD)		-	Modified/Technically Equivalent
40.	IS 17932 (Part 2) : 2024	Biological Evaluation of Medical Devices Part 2 Framework for identification and quantification of potential degradation products		-	Modified/Technically Equivalent
41.	IS 17932 (Part 3) : 2024	Biological Evaluation of Medical Devices Part 3 Identification and quantification of degradation products from metals and alloys		-	Modified/Technically Equivalent
42.	IS 17932 (Part 4) : 2024	Biological Evaluation of Medical Devices Part 4 Physico-chemical morphological and topographical characterization of materials		-	Modified/Technically Equivalent
43.	IS 17932 (Part 6) : 2023	Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization (ISO 10993-10 : 2021, MOD)		-	Modified/Technically Equivalent
44.	IS/ISO 22442-1 : 2015 ISO 22442-1 : 2015	Medical Devices Utilizing Animal Tissues and their Derivatives Part 1 Application of Risk Management		-	Identical under single numbering
45.	IS/ISO 22442-2 : 2015 ISO 22442-2 : 2015	Medical Devices Utilizing Animal Tissues and their Derivatives Part 2 Controls on Sourcing, Collection and Handling		-	Identical under single numbering
46.	IS/ISO 22442-3 : 2007 ISO 22442-3:2007	Medical Devices Utilizing Animal Tissues and their Derivatives Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (TSE) Agents		-	Identical under single numbering
47.	IS/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		-	Identical under single numbering
48.	IS/ISO 23640 : 2011 ISO 23640 : 2011	In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents		-	Identical under single numbering
49.	IS/ISO/TR 37137 : 2014 ISO/TR 37137 : 2014	Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants		-	Identical under single numbering
50.	IS/IEC 61010-2-081 : 2009 IEC 61010-2-081 : 2009	Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-081 Particular Requirements for Automatic and Semi-automatic Laboratory Equipment for Analysis and Other Purposes		-	Identical under single numbering
51.	IS/ISO 7405 : 2008 ISO 7405 : 2008	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry		-	Identical under single numbering

Standards Under Develpoment

Projects Approved

SI. No.	Doc No	TITLE
1	MHD 19 (25234)	Blood Cell Counter Analyzer
2	MHD 19 (25235)	Hemoglobin Analyzer
3	MHD 19 (25236)	Biological evaluation of absorbable medical devices Part 1 General requirements
4	MHD 19 (25237)	Biological evaluation of medical devices Part 33 Guidance on tests to evaluate genotoxicity
5	MHD 19 (25238)	Biological evaluation of medical devices Part 55 Interlaboratory study on cytotoxicity

Preliminary Draft Standards

SI. No.	Doc No	TITLE
No Records Found

Drafts Standards in WC Stage

SI. No.	Doc No	TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.	Doc No	TITLE
No Records Found

Finalized Draft Indian Standard

SI. No.	Doc No	TITLE
No Records Found

Finalized Draft Indian Standards under Print

SI. No.	Doc No	TITLE
1	MHD 19 (15611)	In-vitro Diagnostic IVD Devices - Blood Gas Analyzers
2	MHD 19 (15613)	In-vitro Diagnostic IVD Devices - Electrolyte Analyzer
3	MHD 19 (21867)	Biological Evaluation of Medical Devices Part 5 Ethylene oxide sterilization residuals
4	MHD 19 (22473)	Biological Evaluation of Medical Devices Part 7 Tests for irritation ISO 10993-23 2021 MOD

Total Published Standards:34 Total Standards Under development : 9

Aspect Wise Report

Product:	9
Code of Practices :	1
Methods of Test :	36
Terminology :	0
Dimensions :	0
System Standard :	1
Safety Standard :	4
Others :	0
Service Specification :	0
Process Specification :	0
Unclassified :	0

Total :51

Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.	IS No.	Title
1.	IS/ISO 10993-1 : 2009 ISO 10993-1 : 2009	Biological evaluation of medical devices Part 1 Evaluation and Testing within a risk management process
2.	IS/ISO 10993-10 : 2010 ISO 10993-10 : 2010	Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization
3.	IS 12024 : 1986 Reviewed In : 2006	Code of practice for field monitoring of movement of structures using tape extensometer
4.	IS 12572 (Part 1) : 1994 ISO 10993-1 Reviewed In : 2016	Biological Evaluation of Medical Devices - Part 1 Guidance on Selection of Tests
5.	IS 12572 (Part 2) : 1995 ISO 10993-2 Reviewed In : 2016	Biological evaluation of medical devices Part 2 animal welfare requirements
6.	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
7.	IS 12572 (Part 4) : 2016 ISO 10993-4 : 2002	Biological evaluation of medical devices Part 4 selection of tests for interaction with blood
8.	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
9.	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
10.	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
11.	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
12.	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
13.	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
14.	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
15.	IS 12572 (Part 13) : 1995 ISO 10993-3 Reviewed In : 2016	Biological Evaluation of Medical Devices - Part 13 Tests for Genotoxicity Carcinogenicity and Reproductive Toxicity
16.	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
17.	IS 13020 (Part 1) : 1991 Reviewed In : 2006	Medical Electrical Equipment - Ultrasonic Therapy Equipment - Part 1 Particular Requirements for the Safety
18.	IS 13020 (Part 2) : 1990 Reviewed In : 2010	Medical Electrical Equipment - Ultrasonic Therapy Equipment - Part 2 Constructional and Performance Requirements
19.	IS 13728 : 1993 IEC 520 Reviewed In : 2010	Entrance field sizes of elctro-optical X-ray image intensifiers
20.	IS 13729 : 1993 IEC 572 Reviewed In : 2010	Determination of the luminance distribution of electro-optical X-ray image intensifiers
21.	IS 13807 : 1994 IEC 788 Reviewed In : 2010	Medical radiology - Terminology
22.	IS 13813 : 1993 Reviewed In : 2010	Measurement of the conversion factor of electro-optical X-ray image intensifiers
23.	IS/IEC 61010-1 : 2010 IEC 61010-1 : 2010	Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements
24.	IS 7064 : 1973	Radiation protection in medical X-ray equipment operating at 10 kV to 400 kV
25.	IS 8607 (Part 3) : 1978 Reviewed In : 1987	General and safety requirements for electrical equipment used in medical practice Part 3 Protection against mechanical hazards
26.	IS 8607 (Part 4) : 1985 Reviewed In : 1991	General and safety requirements for electrical equipment used in medical practice Part 4 Protection against unwanted or excessive radiation
27.	IS 8607 (Part 5) : 1983	General and Safety Requirements for Electrical Equipment Used in Medical Practice - Part 5 Protection Against Explosion Hazards
28.	IS 8607 (Part 6) : 1984 Reviewed In : 1991	General and safety requirements for electrical equipment used in medical practice Part 6 Protection against excessive temperatures fire and other hazards
29.	IS 8607 (Part 7) : 1985 Reviewed In : 1991	General and safety requirements for electrical equipment used in medical practice Part 7 Construction
30.	IS 8607 (Part 8) : 1985 Reviewed In : 1991	General and safety requirements for electrical equipment used in medical practice Part 8 Behaviour and reliability
31.	IS 8902 : 1978	Area exposure product meter
32.	IS 9286 (Part 2) : 1988 Reviewed In : 2010	Cardiac Defibrillators - Part 2 Construction and Performance Requirements

Annexure-II :List of Indian Product Standards

SI. No.	IS No. & Year	Title
1.	IS 17713 : 2023	In-Vitro Diagnostic Devices - ELISA Plate Reader
2.	IS 17714 : 2023	In-Vitro Diagnostic Devices - Automated ELISA Processor
3.	IS 17715 : 2023	In-vitro Diagnostic Device - ELISA Plate Washer
4.	IS 17717 (Part 1) : 2023	In-Vitro Diagnostic Device - Automated Clinical chemistry Analyzer - Part 1 Wet Chemistry Analyzer
5.	IS 17717 (Part 2) : 2023	In-Vitro Diagnostic IVD Device - Automated Clinical Chemistry Analyzer Part 2 Dry Chemistry Analyzer
6.	IS 17718 : 2022	Performance testing of In-vitro Diagnostics IVD Reagent Kit alpha - Amylase CNP-G3 Liquid Stable Clinical Chemistry Reagents Kits
7.	IS 17719 : 2023	In-Vitro Diagnostic IVD Medical Device - Automatic Slide Staining Instrument
8.	IS 17720 : 2023	In-vitro Diagnostic Device - Automated Blood Culture and Microbial Detection System
9.	IS 17724 (Part 1) : 2023	Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements IEC 61010-1 2010 AMD1 2016 COR1 2019 MOD