High-quality, efficacy, and safety are of paramount importance in the medical device industry. Medical devices are required to perform as intended for effective health care delivery. Hence, regulatory guidelines and industry standards have been set to monitor medical devices. The International Standardization Organization (ISO) provides frameworks and guidelines for various industries, including medical devices. The medical device ISO standards provide essential guidelines for manufacturers to consistently manufacture high-quality devices. We have listed some of the important ISO Standards for medical devices that manufacturers should be aware of.

List of ISO standards for medical devices

No.	Standard	Name
1.	ISO 13485	Medical devices — Quality management systems — Requirements for regulatory purposes
2.	ISO 14971	Medical devices — Application of risk management to medical devices
3.	IEC 62304	Medical device software — Software life cycle processes
4.	ISO 62366-1	Medical devices – Part 1: Application of usability engineering to medical devices
5.	ISO 11135	Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
6.	ISO 15223-1	Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
7.	ISO 80369-1	Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
8.	ISO 11607-1	Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
9.	ISO 11607-2	Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
10.	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
11.	ISO 14155	Clinical investigation of medical devices for human subjects — Good clinical practice
12.	ISO 19001	In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
13.	ISO/TR 24971	Medical devices — Guidance on the application of ISO 14971
14.	ISO 11737-2	Sterilization of healthcare products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilized product
15.	ISO 16571	Systems for evacuation of plume generated by medical devices
16.	ISO 20916	In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
17.	IEC 80001-1	Safety, effectiveness and security in the implementation and use for connected medical devices or connected health software — Part 1: Application of risk management
18.	IEC/TR 80002-1	Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
19.	IEC/TR 80002-2	Medical device software — Part 2: Validation of software for medical device quality systems
20.	IEC/TR 80002-3	Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
21.	ISO 10993-1	Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
22.	ISO 10993-2	Biological evaluation of medical devices — Part 2: Animal welfare requirements
23.	ISO 10993-4	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
24.	ISO 10993-5	Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
25.	ISO 27186	Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
26.	ISO 15194	In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
27.	ISO 15883-1	Washer Disinfectors — Part 1: General requirements, terms and definitions and tests
28.	ISO 15883-2	Washer Disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
29.	ISO 15883-5	Washer Disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
30.	ISO 9626	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
31.	ISO 11117	Gas cylinders — Valve protection caps and guards — Design, construction and tests
32.	ISO 16142-1	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
33.	ISO 16142-2	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
34.	ISO 17664-1	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
35.	ISO 17664-2	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
36.	ISO 12052	Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management
37.	ISO 14117	Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
38.	ISO 19223	Lung ventilators and related equipment — Vocabulary and semantics
39.	ISO/IEEE 11073- 10101	Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature
40.	ISO 13482	Robots and robotic devices — Safety requirements for personal care robots
41.	ISO 18113-1	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
42.	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
43.	ISO 23640	In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
44.	ISO 23747	Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
45.	ISO 28620	Medical devices — Nonelectrically driven portable infusion devices
46.	ISO 14708-1	Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
47.	ISO 14708-2	Medical devices — Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
48.	ISO 14708-5	Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
49.	ISO 20417	Medical devices — Information to be supplied by the manufacturer
50.	ISO 22442-1	Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
51.	ISO 8871-1	Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -1: Extractables in Aqueous Autoclaves
52.	ISO 8871-2	Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -2: Identification and Characterization
53.	ISO 8871-3	Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -3: Determination of Released-Particle Count
54.	ISO 8871-4	Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -4: Biological requirement and test method
55.	ISO 8871-5	Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -5: Functional Requirements and Testing
56.	ISO 11040-4	Pre-fillable Syringe, Part 4: Glass barrels for injectables and sterilized sub assembled syringes ready for filling
57.	ISO 11040-5	Pre-filled Syringes, Part 5: Plunger Stoppers for Injectables
58.	ISO 11040-7	Prefill able Syringe, Part 7: packaging systems for sterilized sub assembled syringes ready for filling
59.	ISO 11040-8	Requirements and test methods for finished prefilled syringes
60.	ISO 4802-1	Glassware – Hydrolytic Resistance of The Interior Surface of Glass Containers, Part 1: Determination By titration method And Classification
61.	ISO 4802-2	Glassware – Hydrolytic Resistance of The Interior Surface of Glass Containers, Part 2: Determination by Flame Spectrometry and Classification
62.	ISO 15378	Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001: 2008, With Reference to Good Manufacturing Practice (GMP)
63.	ISO 10993-1	Biological Evaluation of Medical Devices – Part-1: Evaluation and Testing
64.	ISO 10993-7	Biological Evaluation of Medical Devices – Part-7: Ethylene Oxide Sterilization Residuals
65.	ISO 13485	Medical Devices – Quality Management Systems – Requirements for Regulatory Purpose
66.	ISO 7886 – 1	Sterile hypodermic syringes for single use
67.	ISO 14971	Medical Devices- Application of Risk Management to Medical Devices
68.	ISO 720	Glass – Hydrolytic Resistance of Glass Grains a 121º C – Method of Test and Classification
69.	ISO 7864	Sterile Hypodermic Needles for Single Use
70.	ISO 9626	Stainless steel needle tubing for manufacture of medical devices
71.	ISO 10993-4	Biological evaluation of medical devices – Selection of tests for interactions with blood
72.	ISO 10993-5	Biological evaluation of medical devices – Tests for in vitro cytotoxicity
73.	ISO 10993-6	Biological evaluation of medical devices – Tests for local effects after implantation
74.	ISO 10993-10	Tests for irritation and skin sensitization
75.	ISO 10993-11	Test for systemic toxicity

Important ISO standards for medical devices industry: A quick reference for manufacturers

1. ISO 13485 (Publication Year: 2016; Edition: 3^rd): ISO 13485 standards outline the guidelines for quality management system for medical device manufacturers. These guidelines mention the QMS criteria that medical device manufacturers must meet. By complying with these guidelines, manufacturers will be able to demonstrate they are capable of consistently producing safe and effective medical devices.
2. ISO 14971 (Publication Year: 2019; Edition: 3^rd): ISO 14971 guidelines state theprocedure for risk management of medical devices, software as a medical device (SaMD), and in vitro medical devices.Guidelines formanufacturers to identify hazards, assess the risks they pose, and implement risk control measures have been outlined. Moreover, ISO 14971’s definition of risk management applies to all stages of the medical device’s lifecycle. 
3. IEC 62304 (Publication Year: 2015; Edition: 1^st): IEC 62304 provides guidelines for the processes, activities, and tasks that occur during the lifecycle of medical device software as well as SaMD.
4. ISO 62366-1 (Publication Year: 2015; Edition: 1^st): ISO 62366-1 outlines instructions on how to assess and mitigate any hazards associated with the device’s routine use. Additionally, it provides guidelines on how to analyze, design, and evaluate the usability of medical devices. Thus, these standards provide usability engineering process for medical devices.
5. ISO 11135 (Publication Year: 2014; Edition: 2^nd): ISO 11135 focuses on requirements for the development, validation, and routine control of a sterilization process for medical devices. This standard lays frameworks for ethylene oxide sterilization of medical devices in both industrial and healthcare environments. 
6. ISO 15223-1 (Publication Year: 2021; Edition: 4^th): These guidelines mention the symbols medical device manufacturers will use to indicate certain information that they will provide with their device. Basically, these are symbols displaying information on the medical equipment’s package, supporting material, or even on the device itself. 
7. ISO 14155 (Publication Year: 2020; Edition: 3^rd): ISO 14155 provides guidelines for clinical investigation of medical devices for human subjects. The standard focuses on good clinical practice for medical device investigation. It encompasses planning, execution, and reporting of studies intended to evaluate the safety and efficacy of medical devices in real-world scenarios.
8. ISO 13482 (Publication Year: 2014; Edition: 1^st): This standard specifies the parameters for creating safe and effective personal care robots. Moreover, it identifies the dangers that these robots pose along with rules and standards for limiting or eliminating the risks that come with their use. 
9. ISO 23640 (Publication Year: 2011; Edition: 1^st): This standard focuses on outlining the criteria for determining the stability of reagents used in IVDs. Moreover, it can be used as a guideline to generate data for IVD reagent shelf life, IVD reagent stability after first opening, and monitoring of IVD reagents already in the market.

Pharmadocx Consultants: Your trusted consultant for medical device ISO standards

 We have listed some of the important ISO standards for medical devices. As an experienced ISO 13485 medical device consultant, we help our clients achieve ISO 13485 compliance in a hassle-free manner. Additionally, we help medical device manufacturers effectively implement the quality management system. Furthermore, we can help you easily secure ISO 13485 certification. Drop an email at [email protected] or call/Whatsapp on 9996859227, for guidance on medical device ISO Standards.