Medical Device & IVD Regulatory | SCIENCE ARENA

In the ever-evolving landscape of medical technology, manufacturers and regulatory bodies alike rely on stringent standards to ensure patient safety and product effectiveness. ISO and BIS standards serve as the guiding stars, providing a roadmap for compliance in the realm of medical devices and In Vitro Diagnostic (IVD) products. In this insightful guide, we embark on a journey through the intricacies of these standards, exploring how they shape the industry and promote excellence in healthcare.

In light of the recent and sweeping changes in global medical device and In Vitro Diagnostic (IVD) regulations, adherence to applicable standards has emerged as an imperative for manufacturers and stakeholders across the industry. With the enforcement of these new regulations, both product-specific and industry-specific standards have transitioned from being optional to becoming a mandatory compass that guides the development, production, and evaluation of medical devices and IVDs. These standards not only serve as essential compliance measures but also play a pivotal role in shaping the landscape of healthcare, ensuring the safety, quality, and effectiveness of the products that impact countless lives worldwide.

The transformation in regulatory landscape necessitates a comprehensive understanding of the standards landscape, their implications, and the benefits they bring to the healthcare ecosystem. In this exploration, we embark on a journey to delve deeper into the significance of adhering to these standards, the key standards governing various aspects of medical devices and IVDs, and the broader implications of this paradigm shift in healthcare regulation. Join us as we navigate the intricate web of standards that underpin the future of medical technology.

Applicable Regulations for Medical Devices and IVDs
INDIA	MDR 2017	Medical Device Rules, 2017
EUROPE	EU MDR 2017/745 EU IVDR 2017/746	Medical Device Regulation 2017/745 In-Vitro Diagnostic regulation 2017/746
USA	21 CFR Part 800	Title-21, Chapter-I, Subchapter-H, Part 800
UK	UK MDR 2002	Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)

View BIS Standards 

STANDARDS FOR MEDICAL DEVICES
S No	Standard	Description	Purpose
1.	IEC 60601-1	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	Electrical Safety
2.	IEC 60601-1-10	Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers	Physiologic Closed-Loop Controllers
3.	IEC 60601-1-11	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environments	Home Healthcare Equipment Safety
4.	IEC 60601-1-12	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment	Emergency Medical Services Equipment Safety
5.	IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests	Electromagnetic Compatibility
6.	IEC 60601-1-4	Medical electrical equipment - Part 1-4: General requirements for basic safety and essential performance - Collateral standard: Programmable electrical medical systems	Programmable Medical Systems
7.	IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	Usability Requirements
8.	IEC 60601-1-8	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems	Alarm Systems in Medical Equipment
9.	IEC 60601-1-9	Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design	Environmentally Conscious Design
10.	IEC 60601-2	Particular requirements for the safety of specific types of medical electrical equipment	Electrical Safety
11.	IEC 60601-2-2	Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories	High-Frequency Surgical Equipment Safety
12.	IEC 60601-2-24	Particular requirements for the basic safety and essential performance of infusion pumps and controllers	Infusion Pumps Safety
13.	IEC 60601-2-25	Particular requirements for the basic safety and essential performance of electrocardiographs	Electrocardiograph Safety
14.	IEC 60601-2-27	Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	Electrocardiographic Monitoring Equipment Safety
15.	IEC 60601-2-28	Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis	X-ray Tube Assemblies Safety
16.	IEC 60601-2-36	Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment	Dental Extraoral X-ray Equipment Safety
17.	IEC 60601-2-37	Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	Ultrasonic Medical Diagnostic and Monitoring Equipment Safety
18.	IEC 60601-2-38	Particular requirements for the basic safety and essential performance of electromyography equipment	Electromyography Equipment Safety
19.	IEC 60601-2-39	Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment	Peritoneal Dialysis Equipment Safety
20.	IEC 60601-2-4	Particular requirements for the basic safety and essential performance of cardiac defibrillators	Cardiac Defibrillator Safety
21.	IEC 60601-2-40	Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment	Electromyographs and Evoked Response Equipment Safety
22.	IEC 60601-2-42	Particular requirements for the basic safety and essential performance of extracorporeally induced lithotripsy equipment	Extracorporeal Lithotripsy Equipment Safety
23.	IEC 60601-2-43	Particular requirements for the safety of surgical luminaires and luminaires for diagnosis	Surgical and Diagnostic Luminaires Safety
24.	IEC 60601-2-44	Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography	Computed Tomography X-ray Equipment Safety
25.	IEC 60601-2-49	Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment	Multifunction Patient Monitoring Equipment Safety
26.	IEC 60601-2-51	Particular requirements for the basic safety and essential performance of recording and analysis equipment	Recording and Analysis Equipment Safety
27.	IEC 60601-2-52	Particular requirements for the basic safety and essential performance of medical beds	Medical Bed Safety
28.	IEC 60601-2-56	Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement	Clinical Thermometers Safety
29.	IEC 60601-2-57	Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, and cosmetic/aesthetic use	Non-Laser Light Source Equipment Safety
30.	IEC 60601-2-58	Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices	Lens Removal and Vitrectomy Devices Safety
31.	IEC 60601-2-61	Particular requirements for basic safety and essential performance of pulse oximeter equipment for medical use	Pulse Oximeter Equipment Safety
32.	IEC 60601-2-66	Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems	Hearing Instruments Safety
33.	IEC 60601-2-70	Particular requirements for the basic safety and essential performance of sleep apnea breathing therapy equipment	Sleep Apnea Breathing Therapy Equipment Safety
34.	IEC 60601-2-8	Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV	Therapeutic X-ray Equipment Safety
35.	IEC 61508	Functional safety of electrical/electronic/programmable electronic safety-related systems	Functional Safety
36.	IEC 62304	Medical device software - Software life cycle processes	Software Development
37.	EC 62304-1	Medical device software - Part 1: Framework for the life cycle processes of medical device software	Software Life Cycle Framework
38.	IEC 62304-2	Medical devices - Part 2: Validation of usability engineering processes	Validation of Usability Engineering Processes
39.	IEC 62304-3	Medical devices - Part 3: Validation of software development processes for medical device software	Validation of Software Development Processes
40.	IEC 62304-4	Medical devices - Part 4: Validation of software requirements	Validation of Software Requirements
41.	IEC 62304-5	Medical devices - Part 5: Validation of software architectural design	Validation of Software Architectural Design
42.	IEC 62304-6	Medical devices - Part 6: Validation of software systems	Validation of Software Systems
43.	IEC 62304-7	Medical device software - Part 7: Application guidance - Software maintenance process	Application Guidance for Software Maintenance Process
44.	IEC 62304-8	Medical device software - Part 8: Application guidance - Software risk management	Application Guidance for Software Risk Management
45.	IEC 62353	Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment	Electrical Testing
46.	IEC 62366	Medical devices - Application of usability engineering to medical devices	Usability Engineering
47.	IEC 62366-1	Medical devices - Part 1: Application of usability engineering to medical devices	Usability Engineering Application
48.	IEC 62366-2	Medical devices - Part 2: Guidance on the application of usability engineering to medical devices	Usability Engineering Application Guidance
49.	IEC 62366-3	Medical devices - Part 3: Guidance on the application of usability engineering to medical devices in development	Usability Engineering Application Guidance in Development
50.	IEC 62366-4	Medical devices - Part 4: Application of usability engineering to medical devices that include software	Usability Engineering Application to Devices with Software
51.	IEC 62366-5	Medical devices - Part 5: Process for usability specifications	Usability Specifications Process
52.	IEC 62366-6	Medical devices - Part 6: Usability evaluation methods	Usability Evaluation Methods
53.	IEC 62366-7	Medical devices - Part 7: Usability evaluation of medical software	Usability Evaluation of Medical Software
54.	IEC 62366-8	Medical devices - Part 8: Usability data exchange	Usability Data Exchange
55.	IEC/TR 62366-2	Medical devices - Part 2: Guidance on the application of usability engineering to medical devices (Technical Report)	Usability Engineering Application Guidance (Technical Report)
56.	ISO 10012	Measurement management systems - Requirements for measurement processes and measuring equipment	Measurement Management
57.	ISO 10013	Guidelines for quality management system documentation	Quality Management System Documentation
58.	ISO 10993	Biological evaluation of medical devices	Biological Safety
59.	ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process	Biological Evaluation Risk Management
60.	ISO 10993-17	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances	Allowable Limits for Leachable Substances
61.	ISO 10993-18	Biological evaluation of medical devices - Part 18: Chemical characterization of materials	Chemical Characterization of Materials
62.	ISO 10993-19	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials	Characterization of Materials
63.	ISO 10993-2	Biological evaluation of medical devices - Part 2: Animal welfare requirements	Animal Welfare in Biological Evaluation
64.	ISO 10993-3	Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity	Genotoxicity, Carcinogenicity, and Reproductive Toxicity Testing
65.	ISO 11135	Sterilization of health care products - Ethylene oxide	Ethylene Oxide Sterilization
66.	ISO 11137	Sterilization of health care products - Radiation	Sterilization
67.	ISO 11137-1	Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices	Radiation Sterilization Process
68.	ISO 11139	Sterilization of health care products - Validation of the performance of sterilizers	Sterilizer Performance Validation
69.	ISO 11140	Sterilization of health care products - Chemical indicators - Part 1: General requirements	Chemical Indicators for Sterilization
70.	ISO 1135	Transfusion equipment for medical use	Transfusion Equipment
71.	ISO 11607	Packaging for terminally sterilized medical devices	Packaging
72.	ISO 11608	Needle-based injection systems for medical use - Requirements and test methods	Needle-based Injection Systems
73.	ISO 11737	Sterilization of medical devices - Microbiological methods	Microbiological Methods for Sterilization
74.	ISO 11737-1	Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products	Microbiological Population Determination
75.	ISO 11737-2	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process	Sterility Testing in Sterilization Validation
76.	ISO 11737-3	Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data	Bioburden Data Evaluation
77.	ISO 11979	Ophthalmic implants - Intraocular lenses	Intraocular Lenses
78.	ISO 1302	Geometrical Product Specifications (GPS) - Indication of surface texture in technical product documentation	Indication of Surface Texture
79.	ISO 13408	Aseptic processing of health care products	Aseptic Processing
80.	ISO 13408-1	Aseptic processing of health care products - Part 1: General requirements	General Requirements for Aseptic Processing
81.	ISO 13408-2	Aseptic processing of health care products - Part 2: Sterilization-in-place	Sterilization-in-place for Aseptic Processing
82.	ISO 13485	Quality management systems - Medical devices - Requirements for regulatory purposes	Quality Management
83.	ISO 13732	Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces	Assessment of Human Responses to Hot Surfaces
84.	ISO 14155	Clinical investigation of medical devices for human subjects - Good clinical practice	Clinical Investigation
85.	ISO 14160	Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation, and routine control of a sterilization process for medical devices	Liquid Chemical Sterilization Agents
86.	ISO 14161	Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results	Biological Indicators for Sterilization
87.	ISO 14385	Sterile single-use intravascular catheters - Particular requirements for intravascular catheters with enhanced features for guidewire access in a sterile field	Intravascular Catheters with Enhanced Features
88.	ISO 14630	Non-active surgical implants - General requirements	Non-active Surgical Implants
89.	ISO 14708	Implants for surgery - Active implantable medical devices	Active Implantable Medical Devices
90.	ISO 14937	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process	Sterilization Process Control
91.	ISO 14971	Medical devices - Application of risk management to medical devices	Risk Management
92.	ISO 15001	Medical electrical equipment - Guidance on the application of usability engineering to medical electrical equipment and medical electrical systems	Usability Engineering Guidance
93.	ISO 15004	Ophthalmic instruments - Fundamental requirements and test methods for light hazard protection	Light Hazard Protection for Ophthalmic Instruments
94.	ISO 15012	Sterilization of health care products - Biological and chemical indicators - Test equipment	Test Equipment for Biological and Chemical Indicators
95.	ISO 15189	Medical laboratories - Requirements for quality and competence	Laboratory Quality
96.	ISO 15223-1	Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied	Labeling Symbols
97.	ISO 15223-2	Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 2: Symbol development, selection, and validation	Symbol Development and Validation
98.	ISO 16061	Cardiovascular implants - Tubular vascular grafts	Tubular Vascular Grafts
99.	ISO 17025	General requirements for the competence of testing and calibration laboratories	Testing and Calibration Competence
100.	ISO 17664	Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices	Manufacturer's Instructions for Resterilizable Devices
101.	ISO 17664-2	Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1	Guidance on the Application of Moist Heat Sterilization
102.	ISO 17665	Sterilization of health care products - Moist heat	Moist Heat Sterilization
103.	ISO 17665-1	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices	Moist Heat Sterilization Process Requirements
104.	ISO 18562	Biocompatibility evaluation of breathing gas pathways in healthcare applications	Biocompatibility Evaluation
105.	ISO 18562-1	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing	Biocompatibility Evaluation of Breathing Gas Pathways
106.	ISO 20342	Dentistry - Medical devices for dentistry - Articulating paper	Articulating Paper for Dentistry
107.	ISO 21929	Cardiovascular implants - Tubular vascular prostheses	Tubular Vascular Prostheses
108.	ISO 5840	Cardiovascular implants - Cardiac valve prostheses	Cardiac Valve Prostheses
109.	ISO 5841	Implants for cardiac pacing - Pacemakers	Cardiac Pacemakers
110.	ISO 80601-2-55	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors	Respiratory Gas Monitors
111.	ISO 80601-2-74	Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment	Respiratory Humidifying Equipment Safety
112.	ISO 20417	Medical devices — Information to be supplied by the manufacturer	Information to be supplied by the manufacturer
113.	ISO/TR 20416	Medical devices — Post-market surveillance for manufacturers	Post market surveillance

STANDARDS FOR IN-VITRO DIAGNOSTIC DEVICES
S No	Standard	Description	Purpose
1.	ISO 15189	Medical laboratories - Requirements for quality and competence	requirements for the competence and quality of medical laboratories, including those performing diagnostic testing with IVD devices
2.	ISO 15197	In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus	requirements for the accuracy and reliability of blood-glucose monitoring systems used for self-testing by individuals managing diabetes
3.	ISO 22870	Point-of-care testing (POCT) - Requirements for quality and competence	quality and competence requirements for healthcare facilities and professionals performing point-of-care testing using IVD devices
4.	ISO 18113-1	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements	terms and requirements for the labeling of IVD devices to ensure clear and accurate information is provided to users
5.	ISO 23640	In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents	principles for evaluating the stability of in vitro diagnostic reagents, ensuring their reliability and performance over time.

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