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) |
STANDARDS
FOR MEDICAL DEVICES |
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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. |