Ask Whether Your Standard is Certifiable or Not? Or Any Enquiry
|
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 60601-2-41 |
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 |
||
|
37. |
EC 62304-1 |
Medical device
software -
Part 1:
Framework for the life cycle processes of medical device software |
|
|
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 |
|
|
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 |
|
|
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. |
|
6.
|
ISO 13408-1 |
Aseptic processing of health care products - Part 1: General requirements |
principles for aseptic manufacturing. |
|
7.
|
ISO 13408-6 |
Aseptic processing of health care products - Part 6: Isolator systems |
principles for aseptic manufacturing. |
|
8.
|
ISO 17511 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. |
|
9.
|
ISO 20916 |
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice |
Good Study parctice on IVDs |
EMI/EMC (Electromagnetic compatibility Immunity (EMI)/ Electromagnetic compatibility (EMC) Standards
IEC 61326-1 | Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements |
IEC 61000-3-2 | Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase) |
IEC 61000-3-3 | Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection |
IEC 61000-3-11 | Electromagnetic compatibility (EMC) – Part 3- 11: Limits – Limitation of voltage changes, voltage fluctuations and flicker in public low- voltage supply systems — Equipment with rated current <= 75 A and subject to conditional connection |
IEC 61000-3-12 | Electromagnetic compatibility (EMC) – Part 3- 12: Limits – Limits for harmonic currents produced by equipment connected to public low-voltage systems with input current > 16 A and <= 75 A per phase |
IEC 61000-6-1 | Electromagnetic compatibility (EMC) – Part 6-1: Generic standards – Immunity for residential, commercial and light-industrial environments I |
IEC 61000-6-2 | Electromagnetic compatibility (EMC) – Part 6-2: Generic standards – Immunity for industrial environments |
IEC 61000-6-3 | Electromagnetic compatibility (EMC) – Part 6-3: Generic standards – Emission standard for residential, commercial and light-industrial environments |
IEC 61000-6-4 | Electromagnetic compatibility (EMC) – Part 6-4: Generic standards – Emission standard for industrial environments |
IEC 61000-6-5 | Electromagnetic compatibility (EMC) – Part 6-5: Generic standards – Immunity for equipment used in power station and substation environment |
IEC 61000-4-2 | Electromagnetic compatibility (EMC) – Part 4-2: Generic standards – Testing and measurement techniques – Electrostatic discharge immunity test |
IEC 61000-4-4 | Electromagnetic compatibility (EMC) – Part 4-4: Generic standards – Testing and measurement techniques – Electrical fast transient/burst immunity test |
IEC 61000-4-5 | Electromagnetic compatibility (EMC) – Part 4-5: Generic standards – Testing and measurement techniques – Surge immunity test |
Standards for Hospital equipment – Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.
ISO 10282 | Single-use sterile rubber surgical gloves — Specification |
ISO 11193-1 | Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution |
ISO 11193-2 | Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride) |
ISO 21171 | Medical gloves — Determination of removable surface powder |
ISO 22609 | Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) |
ISO 22610 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration |
ISO 22882 | Castors and wheels — Requirements for castors for hospital beds |
IEC/TR 60601-4-1: | Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy |
IEC 60601-2-52 | Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Amendment 1 |
IEC 60601-2-52:2009/Cor 1 | Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Technical Corrigendum 1 |
IEC 60601-2-31 | Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
IEC/DIS 80601-2-52 | Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
IEC/DIS 80601-2-89 | Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children |
Newly Added Standards in 2024 for Medical Devices
|
ISO 10394:2023 |
Dentistry — Designation system for supernumerary teeth |
|
ISO 23402-3:2024 |
Dentistry — Portable dental equipment for use in non‐permanent healthcare environment |
|
ISO 5832-1:2024 |
Implants for surgery - Metallic materials -Part 1: Wrought stainless steel |
|
ISO 5832-4:2024 |
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy |
|
ISO 5832-7:2024 |
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel molybdenumiron alloy |
|
ISO 8637-2:2024 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
|
ISO 23500-3:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
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ISO 23500-4:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies -Part 4: Concentrates for haemodialysis and related therapies |
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ISO 23500-5:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
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ISO 7151:2024 |
Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods |
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ISO 16840-2:2018/Amd1:2024 |
Wheelchair seating - Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity - Amendment 1: Updates and addition of new Annex covering alternatively sized cushions |
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ISO 16840-10:2021/Amd 1:2024 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices -Requirements and test method -Amendment 1: Amended with additional Annexes and test method XZ |
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ISO/TS 16840-15:2024 |
Wheelchair seating - Part 15: Selection, placement and fixation of flexible postural support devices in seating |
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ISO 16021:2024 |
Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers |
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ISO 21860:2020 |
Health Informatics — Reference standards portfolio (RSP) — Clinical imaging |
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ISO 18209-1:2024 |
Biotechnology - Biobanking of parasites - Part 1: Helminths |
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ISO/IEC 15421:2010 |
Information technology -Automatic identification and data capture techniques - Bar code master test specifications |
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ISO 23500-1:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements |
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ISO 23500-2:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies |
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ISO 23500-3:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies |
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ISO 23500-4:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies |
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ISO 23500-5:2024 |
Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
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