Satori One Click Solutions is a Global Pharma & QA/QC Management, Legal and Regulatory Compliance Consultancy and Advisory Company rendering services to Pharma and other Healthcare product industries/sectors including Pharmaceuticals, API, Medical Devices, Cosmetics, Natural Health Products, Herbal Products, Nutraceuticals, Dietary Supplements, Food Products particularly for USFDA, Health Canada, CDSCO, EMA, MHRA, TGA, and other countries’ regulatory compliance matters. It has been established with the aims & objectives of providing dedicated consultancy services round the clock, globally, across a varied range of service areas, in a cost effective and innovative manner keeping in view the specific needs and benefits of prospective clients through a team of committed professionals with a legacy of experience, knowledge, integrity and sound ethical practices. Satori operates from offices in India, Canada, and the US, maintaining alliances with dedicated teams worldwide to meet clients' demand. The firm ensures high standards and quality of work by continuously monitoring and checking delegated tasks. Satori offers complete outsourcing solutions, helping clients in various aspects of their operations, including identifying manufacturing sites, managing sourcing, ensuring GxP compliances, obtaining regulatory approvals, and conducting production site audits, QA-QC audits, facility audits, and more. The company also provides consulting services that encompass Current Good Manufacturing Practices (cGMP), quality management, Good Laboratory Practice (GLP), validation, qualification, and regulatory agency documentation. Satori specializes in USFDA, Health Canada, EU, CDSCO, EDQM, MHRA, TGA, and other countries' regulatory compliance matters, offering a comprehensive solution to clients in the Indian and international markets.
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ISO Standards Directory – Complete Reference List for Medical Devices, IVDs, Cosmetics & Healthcare
ISO Standards Directory – Complete Reference List for Medical Devices, IVDs, Cosmetics & Healthcare
SATORI ONE CLICK SOLUTION LLP
April 16, 2026
Home Medical Devices

The International Organization for Standardization (ISO) has released multiple updated standards for medical devices, IVDs, and healthcare systems in 2025 and 2026.

This article provides a comprehensive list of key ISO standards relevant to medical device manufacturers, quality professionals, and regulatory affairs teams.

Top Medical Device Standards (Recently Published or Reviewed)
Sno.StandardTitlePublished/Reviewed
1ISO 14155Clinical investigation of medical devices for human subjects — Good clinical practice2026
2ISO 20417Medical devices — Information to be supplied by the manufacturer2026
3ISO 10993-1Biological evaluation of medical devices — Part 1: Requirements and general principles2025
4ISO 80601-2-61Medical electrical equipment — Part 2-61: Pulse oximeter equipment2026
5ISO 80601-2-74Medical electrical equipment — Part 2-74: Respiratory humidifying equipment2026
6ISO 15223-1Medical devices — Symbols to be used with information supplied by the manufacturer2021 (Reviewed)
7ISO 13485Medical devices — Quality management systems — Requirements for regulatory purposes2025
8ISO 14971Medical devices — Application of risk management2025
9ISO 22367Medical laboratories — Application of risk management to medical laboratories2026
10ISO 80601-2-69Medical electrical equipment — Part 2-69: Oxygen concentrator equipment2026
11IEC 62366-1Medical devices — Part 1: Application of usability engineering2021
12IEC 62304Medical device software — Software life cycle processes2021
13ISO 15189Medical laboratories — Requirements for quality and competence2022
14ISO 7101Healthcare organization management — Management systems for quality in healthcare organizations2023
Biological Evaluation & Biocompatibility Standards
15ISO 10993-12Biological evaluation of medical devices — Part 12: Sample preparation and reference materials2021
16ISO 10993-17Biological evaluation of medical devices — Part 17: Toxicological risk assessment2023
17ISO 10993-18Biological evaluation of medical devices — Part 18: Chemical characterization2025
18ISO 10993-23Biological evaluation of medical devices — Part 23: Tests for irritation2021
19ISO 10993-4Biological evaluation of medical devices — Part 4: Tests for interactions with blood2017
20ISO 10993-10Biological evaluation of medical devices — Part 10: Tests for skin sensitization2021
21ISO 10993-5Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity2022
22ISO 10993-11Biological evaluation of medical devices — Part 11: Tests for systemic toxicity2017
23ISO 10993-7Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals2008
24ISO 10993-3Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity2014
25ISO 10993-6Biological evaluation of medical devices — Part 6: Tests for local effects after implantation2016
26ISO/TR 24971Medical devices — Guidance on the application of ISO 149712020
Sterilization Standards
27ISO 11135Sterilization of health-care products — Ethylene oxide2014
28ISO 11137-1Sterilization of health care products — Radiation — Part 1: Requirements2025
29ISO 17665Sterilization of health care products — Moist heat2024
30ISO 11607-1Packaging for terminally sterilized medical devices — Part 1: Requirements2024
31ISO 11607-2Packaging for terminally sterilized medical devices — Part 2: Validation requirements2024
32ISO 11737-1Sterilization of health care products — Microbiological methods — Part 1: Population of microorganisms2018
33ISO 11737-2Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility2025
34ISO 11737-3Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing2023
35ISO 14937Sterilization of health care products — General requirements for characterization of a sterilizing agent2009
36ISO 22441Sterilization of health care products — Low temperature vaporized hydrogen peroxide2022
37ISO 11138-1Sterilization of health care products — Biological indicators — Part 1: General requirements2022
38ISO 11140-1Sterilization of health care products — Chemical indicators — Part 1: General requirements2014
Cleanrooms & Controlled Environments
39ISO 14644-1Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness2021
40ISO 14644-2Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance2021
41ISO 14644-3Cleanrooms and associated controlled environments — Part 3: Test methods2019
42ISO 14644-4Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up2022
43ISO 14644-5Cleanrooms and associated controlled environments — Part 5: Operations2025
44ISO 14644-7Cleanrooms and associated controlled environments — Part 7: Separative devices2004
45ISO 14644-8Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness by chemical concentration2022
46ISO 14644-9Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness for particle concentration2022
47ISO 14644-10Cleanrooms and associated controlled environments — Part 10: Assessment of surface cleanliness for chemical contamination2022
48ISO 14644-12Cleanrooms and associated controlled environments — Part 12: Specifications for monitoring air cleanliness2018
49ISO 14644-13Cleanrooms and associated controlled environments — Part 13: Cleaning of surfaces to achieve defined levels of cleanliness2026
50ISO 14644-14Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use of equipment2026
51ISO 14644-15Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment2017
52ISO 14644-16Cleanrooms and associated controlled environments — Part 16: Energy efficiency in cleanrooms2019
53ISO 14644-17Cleanrooms and associated controlled environments — Part 17: Particle deposition rate applications2021
54ISO 14644-18Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables2023
Software & Digital Health Standards
55IEC 62304Medical device software — Software life cycle processes2021
56IEC 62366-1Medical devices — Part 1: Application of usability engineering2021
57IEC/TR 62366-2Medical devices — Part 2: Guidance on the application of usability engineering2016
58IEC 81001-5-1Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle2021
59IEC 82304-1Health software — Part 1: General requirements for product safety2021
60ISO/IEC 29138-1Information technology — User interface accessibility — Part 1: User accessibility needs2024
61ISO 27799Health informatics — Information security management in health using ISO/IEC 270022025
62ISO 81001-1Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts2021
63IEC 80001-1Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security2021
In Vitro Diagnostic (IVD) Standards
64ISO 15189Medical laboratories — Requirements for quality and competence2022
65ISO 22367Medical laboratories — Application of risk management to medical laboratories2026
66ISO 23640In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents2011
67ISO 17511In vitro diagnostic medical devices — Requirements for establishing metrological traceability2026
68ISO 20916In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice2025
69ISO 5649Medical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed tests2024
70ISO 20387Biotechnology — Biobanking — General requirements for biobanking2018
71ISO 20395Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR2019
72CLSI EP SeriesIVD performance evaluation standardsVarious dates
Medical Electrical Equipment (IEC 60601 Series)
73IEC 60601-1-8Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: Alarm systems2006
74IEC 60601-1-11Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Home healthcare environment2025
75IEC 60601-1-12Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral standard: Emergency medical services environment2014
76IEC 80601-2-61Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment2026
77IEC 80601-2-69Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment2026
78IEC 80601-2-74Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment2026
79IEC 80601-2-49Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment2018
80IEC 80601-2-77Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment2019
81IEC 80601-2-78Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation2019
82IEC 80601-2-89Medical electrical equipment — Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children2025
Labelling & Symbols Standards
83ISO 20417Medical devices — Information to be supplied by the manufacturer2026
84ISO 15223-1Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements2021
85ISO 15223-2Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation2010
86ISO 18113-1In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements2022
87ISO 18113-2In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use2022
88ISO 18113-3In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use2022
89ISO 18113-4In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing2022
90ISO 18113-5In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing2022
Quality Management & Risk Management Standards
91ISO 13485Medical devices — Quality management systems — Requirements for regulatory purposes2025
92ISO 14971Medical devices — Application of risk management to medical devices2025
93ISO/TR 24971Medical devices — Guidance on the application of ISO 149712020
94ISO 15378Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)2023
95ISO 7101Healthcare organization management — Management systems for quality in healthcare organizations — Requirements2023
96ISO 35001Biorisk management for laboratories and other related organisations2019
Implants & Surgical Devices Standards
97ISO 14630Non-active surgical implants — General requirements2024
98ISO 5832-1Implants for surgery — Metallic materials — Part 1: Wrought stainless steel2024
99ISO 5832-2Implants for surgery — Metallic materials — Part 2: Unalloyed titanium2025
100ISO 5832-3Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy2021
101ISO 5832-4Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy2024
102ISO 5832-5Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel2022
103ISO 5832-6Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy2022
104ISO 5832-11Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy2024
105ISO 5832-12Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy2019
106ISO 5834-1Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form2025
107ISO 5834-2Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms2025
108ISO 5834-3Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods2025
109ISO 5834-4Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method2025
110ISO 5834-5Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method2025
111ISO 5840-1Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements2021
112ISO 5840-2Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes2021
113ISO 5840-3Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques2021
114ISO 14607Non-active surgical implants — Mammary implants — Specific requirements2024
115ISO 21534Non-active surgical implants — Joint replacement implants — Particular requirements2021
116ISO 21535Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants2023
117ISO 21536Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants2023
118ISO 25539-1Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses2022
119ISO 25539-2Cardiovascular implants — Endovascular devices — Part 2: Vascular stents2020
120ISO 25539-3Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters2024
121ISO 7198Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches2016
122ISO 14708-1Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer2014
123ISO 14708-2Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers2025
124ISO 14708-3Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators2017
125ISO 14708-4Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems2022
126ISO 14708-5Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices2020
127ISO 14708-6Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)2025
128ISO 14708-7Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems2026
Post-Market Surveillance & Vigilance Standards
129ISO/TR 20416Medical devices — Post-market surveillance for manufacturers2020
130ISO/TS 5137Medical device maintenance management programme for healthcare delivery organizations (HDO)2026
131ISO/TR 18965Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems2025
Cosmetic & Personal Care Product Standards
132ISO 22716Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices2022
133ISO 24444Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)2019
134ISO 24442Cosmetics — Sun protection test methods — In vivo determination of sunscreen UVA protection2022
135ISO 23675Cosmetics — Sun protection test methods — In vitro determination of sun protection factor (SPF)2024
136ISO 23698Cosmetics — Measurement of the sunscreen efficacy by diffuse reflectance spectroscopy2024
137ISO 16128-1Cosmetics — Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients — Part 1: Definitions for ingredients2016
138ISO 16128-2Cosmetics — Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients — Part 2: Criteria for ingredients and products2017

How Satori One Click Solutions LLP Can Help

We support medical device manufacturers with:

  • ISO 13485 QMS implementation & certification support
  • ISO 14971 risk management file development
  • ISO 10993 biological evaluation planning
  • IEC 62304 software lifecycle documentation
  • IEC 62366-1 usability engineering
  • ISO 20417 labeling compliance
  • Sterilization validation (ISO 11135, 11137, 17665)
  • Cleanroom compliance (ISO 14644 series)
  • Post - Market surveillance & vigilance (ISO/TR 20416)
  • Regulatory submissions (FDA, CDSCO, TGA, Health Canada, EU MDR)

Contact us:

  • 📧 satoriocs@gmail.com
  • 📞 +91 9829098077 / +91 9216598077
  • 🌐 satoriocs.com

🔖Tags: ISO ISO 13485 medical device
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