Ali TizMaghz

Standards in Medicine

Standards are the shared rules behind safe medical devices and well-run medical centers. Here I introduce the twenty-six I find most useful in medical engineering and in running a medical center: what each one is for, who uses it and why it matters, and where to get its official text, in Persian or Arabic where an official edition exists.

About this page: An introduction in my own words: not a substitute for the standards, and not a translation of them. The official texts are linked at the end of the page, and I earn nothing from the links.

Five families of cells met to agree on one way of doing things. It took a lot of dividing, but in the end they stood in a single ring, closed it and signed it with a tick. That’s more or less how a standard is made, only much faster.

What a standard is

A standard is an agreed way of doing something: how to manage the risks of a device, how to test it, which symbol on its label means what. International standards are written by committees of experts from many countries, at ISO, the International Organization for Standardization, and, for electrical and electronic technology, at the IEC, the International Electrotechnical Commission. They are agreed by vote, reviewed every few years, and replaced by new editions as practice moves on. National bodies, such as INSO in Iran and GSO for the Gulf states, adopt many of them as national standards, often in their own language.

A standard is not a law. Following one is voluntary in itself, but regulators rely on them: since February 2026 the US FDA’s quality rules for device makers have included ISO 13485, and the European Union lists the standards that show a device meets its rules. In practice, a maker or a medical center that follows the right standards can show that it has done its work properly.

Why standards matter in medicine

In medicine, standards are about people: the safety that a patient on a treatment couch and a nurse at the bedside can expect, the evidence that a device does what its maker says, and a shared language between makers, medical centers, regulators and auditors.

For a medical center, standards are practical tools. They help decide what to ask for when buying a device, how to accept it before its first use, how to test it after a repair and at regular intervals, how to plan its maintenance, and how to manage the risks when devices are connected to a network or used by busy staff.

Why medical engineers should know them

Medical engineers meet standards every working day, often without naming them: judging a supplier’s quality system, accepting a new device, testing a device after a repair, planning maintenance, writing a risk or incident report, connecting equipment to the hospital network. Knowing the standards behind this work makes it safer, and easier to explain to managers, auditors and regulators.

Standards change: they are revised, amended and replaced. Knowing them well is not a course taken once, but a habit worth keeping over a whole career.

Quality and risk

How device makers run their quality systems, how anyone, maker or medical center, manages the risks of a device, and how any organization manages its risks, with the methods to assess them.

ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Current edition: ISO 13485:2016

The quality management system of an organization that designs, makes, stores, services or sells medical devices. It asks for documented processes and records as evidence: design, purchasing, production and traceability, complaints, corrective action, internal audits and management review. Unlike ISO 9001, it is written around what regulators need, so it puts safety and evidence before customer satisfaction.

Who uses it: Device makers and their suppliers, quality managers, auditors and regulators; and medical centers judging a supplier.

Why it matters: A supplier that works to ISO 13485 shows that it follows a recognized quality system. For a medical engineer it is the shared quality language of the device world, and it is part of the US rules for device makers since February 2026.

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ISO 14971

Medical devices — Application of risk management to medical devices

Current edition: ISO 14971:2019

How to manage the risks of a medical device over its whole life: find the hazards, estimate and evaluate the risks, control them (by safer design first, then protective measures, then information for users), weigh what risk remains against the benefit, and keep learning from what happens in use. A separate guide, ISO/TR 24971, explains how to apply it.

Who uses it: Device makers above all; also regulators, and medical centers, whose reports of problems feed back into the makers’ risk files.

Why it matters: Risk management is the idea that ties the other standards together. An engineer who thinks in hazards, harms and controls makes better decisions about buying, using and maintaining devices.

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ISO 31000

Risk management — Guidelines

Current edition: ISO 31000:2018

IEC 31010

Risk management — Risk assessment techniques

Current edition: IEC 31010:2019

ISO 31000 gives principles, a framework and a process for managing risk in any organization: setting the scope and context, identifying, analyzing and evaluating risks, treating them, and monitoring, reviewing and communicating all along. It offers guidelines, not requirements, so organizations are not certified to it. IEC 31010 is its toolbox: it describes many ways to assess risk, from brainstorming and structured interviews to failure mode and effects analysis (FMEA), fault trees and bow-tie diagrams, and helps choose among them.

Who uses it: Managers, quality and patient safety teams and clinical engineers in medical centers, and risk managers in every field.

Why it matters: ISO 14971 is about the risks of a device. A medical center has many other risks, clinical, technical and financial, and ISO 31000 gives one shared way to manage them all. IEC 31010 gives the practical methods, such as FMEA, that engineers use to study a process or a failure.

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Electrical safety

The safety of the electrical equipment around patients: how it is designed, the extra rules for radiotherapy accelerators, how it is tested in service, and the electrical installation of the rooms where patients are treated.

IEC 60601-1

Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

Current edition: IEC 60601-1:2005+AMD1:2012+AMD2:2020

The general safety standard for medical electrical equipment: protection against electric shock, heat, fire, moving parts and unwanted radiation, and the performance a device must keep to stay safe. It heads a large family: collateral standards (IEC 60601-1-x) on shared topics such as electromagnetic compatibility and alarms, and particular standards (IEC 60601-2-x) for each kind of device.

Who uses it: Device makers and test laboratories; medical engineers and students learning how medical equipment is kept safe.

Why it matters: Almost every electrical device in a medical center is designed to it. Its ideas, such as two independent means of protection and the types of parts that touch the patient, help an engineer understand the equipment and its tests.

PaidWhere to get it

IEC 60601-2-1

Medical electrical equipment — Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

Current edition: IEC 60601-2-1:2020

The particular standard for the electron accelerators (linacs) used in radiotherapy. It adapts the general standard to these machines: how the dose is monitored, by two independent channels that back each other up; the interlocks that stop or prevent a beam; how a treatment is interrupted and ended; and which tests the maker does and which are done at installation.

Who uses it: Makers of radiotherapy machines, radiotherapy engineers and medical physicists, and students.

Why it matters: A linac treats patients with high-energy radiation, so its safety systems must work every time. For engineers in a radiotherapy center, it explains the safety logic of the machine they look after.

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IEC 62353

Medical electrical equipment — Recurrent test and test after repair of medical electrical equipment

Current edition: IEC 62353:2014

The tests done on medical electrical equipment in service: before its first use, at regular intervals and after a repair. It describes the usual order (a visual inspection, the protective earth, insulation and leakage currents, a check that the device works) and how to record the results. These tests differ from a maker’s type tests, which are done once, on a design.

Who uses it: Clinical engineering and service teams in medical centers, and service engineers.

Why it matters: It is the standard closest to a medical engineer’s daily work: the tests that show a repaired or aging device is still safe for patients. Only trained staff with the right equipment should do them.

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IEC 60364-7-710

Low-voltage electrical installations — Part 7-710: Requirements for special installations or locations — Medical locations

Current edition: IEC 60364-7-710:2021

The electrical installation of the rooms where patients are examined and treated. It sorts these medical locations into groups by what a power failure would mean for the patient, from rooms where no equipment touches the patient to operating rooms and intensive care units, where equipment may reach the heart or keep a patient alive. For these it asks for extra protection: a medical IT system, fed through an isolating transformer and watched by an insulation monitor, so that a first fault sounds an alarm instead of cutting the power; bonding that keeps the metal parts around the patient at the same potential; and a safety power supply that takes over within seconds when the main power supply fails.

Who uses it: Electrical engineers who design hospitals, the engineering and maintenance teams of medical centers, and clinical engineers.

Why it matters: The safety of a medical device also depends on the installation it is plugged into. In an operating room or an intensive care unit, a single fault must not stop life-support equipment, and stray currents must be kept away from a patient whose heart may be reached by a catheter. This standard explains the isolated outlets, alarm panels and backup supplies of these rooms, and what to check when a room is built or changed.

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Equipment in the medical center

Looking after devices well once they are in use: a planned maintenance program and the engineering behind it, the full cost of a device from purchase to disposal, and devices connected to networks, including remote maintenance by their makers.

ISO/TS 5137

Medical device maintenance management programme for healthcare delivery organizations (HDO)

Current edition: ISO/TS 5137:2026

A new technical specification, published in February 2026, on how a medical center runs the care of its reusable devices as a planned program: who does what, checks before use, preventive maintenance and calibration, repairs, records, and taking devices out of service, with the effort set by risk. It does not cover makers who service their own devices.

Who uses it: Medical centers and their clinical engineering services, health care managers, and students.

Why it matters: It describes the heart of a clinical engineer’s work in a medical center, which is why it is the one I would read first.

PaidWhere to get it

IEC 60300-3-14

Dependability management — Part 3-14: Application guide — Supportability and support

Current edition: IEC 60300-3-14:2024

IEC 60300-3-11

Dependability management — Part 3-11: Application guide — Reliability centred maintenance

Current edition: IEC 60300-3-11:2009

Two application guides in the IEC’s series on dependability, the ability of an item to perform as and when required. IEC 60300-3-14, whose 2024 edition is called “Supportability and support”, is about the support an item needs over its life, such as maintenance, spare parts, tools, people and documents, and about designing items that are easy to support. IEC 60300-3-11 explains reliability-centered maintenance (RCM): for each way an item can fail, choosing the task that prevents the failure or finds it in time, according to its consequences.

Who uses it: Maintenance managers and engineers in every industry; in medicine, clinical engineering teams planning the maintenance of devices and systems.

Why it matters: They are general standards, not written for medicine, but they explain the reasoning behind a good maintenance program: why some devices need scheduled tasks, others only checks, and some may be used until they fail. They give a medical center’s planned program a sound engineering basis.

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IEC 60300-3-3

Dependability management — Part 3-3: Application guide — Life cycle costing

Current edition: IEC 60300-3-3:2017

Life cycle costing: estimating the total cost of an item over its whole life, from buying and installing it, through running, maintaining and repairing it, to taking it out of service and disposing of it. It explains how to build a cost model, which costs to include and how to use the results to compare options.

Who uses it: Engineers, purchasing and finance teams, and managers deciding what to buy and when to replace it.

Why it matters: The cheapest device to buy is not always the cheapest to own. For a medical center, life cycle costing gives a fair way to compare offers and to plan the replacement of aging equipment.

PaidWhere to get it

IEC 80001-1

Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Current edition: IEC 80001-1:2021

Connecting medical devices to a network brings new risks to safety, effectiveness and security. This standard sets out how a health care organization manages those risks when devices or health software are connected, changed or disconnected, and who is responsible for what.

Who uses it: Health care managers, hospital IT staff and clinical engineers, working with the makers of connected devices.

Why it matters: Today a radiotherapy system, a patient monitor or an infusion pump is often part of a network. A medical engineer needs to see how a change to the network can affect a patient.

PaidWhere to get it

ISO/TS 11633-1

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

Current edition: ISO/TS 11633-1:2026

The information security of remote maintenance, when a maker or a service company maintains medical devices or medical information systems over a network: the risks to patient data and to the systems, and what the health care organization and the service provider must each do about them, such as controlling who connects and when, and which information they may reach and how far, protecting the connection and keeping records of each session.

Who uses it: Health care IT and security staff, clinical engineers, and makers and service companies that offer remote maintenance.

Why it matters: More and more devices, such as imaging systems, are maintained remotely by their makers. A medical engineer needs to know what to ask of such a service, so that a remote connection does not open a door to patient data or to the device itself.

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Materials, labels and use

What a device is made of, the general requirements for implants, what its label says, and how its design helps people use it without mistakes.

ISO 10993-1

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Current edition: ISO 10993-1:2025

How to judge whether the materials of a device are safe for the body they touch. It treats this as part of risk management, not as a checklist of tests: first describe the device, its materials, and how and for how long it touches the body; then decide which effects need evidence, and test only where it is needed. The 2025 edition also asks makers to consider misuse that can reasonably be foreseen.

Who uses it: Device makers, biomaterials and tissue engineering researchers, test laboratories and students.

Why it matters: For biomaterials and tissue engineering, my own field, it is the starting point for biological safety, and it helps avoid animal tests where they are not needed.

PaidWhere to get it

ISO 14630

Non-active surgical implants — General requirements

Current edition: ISO 14630:2024

General requirements for non-active surgical implants, those without a power source of their own, such as joint replacements, bone plates and screws, and breast implants: their intended performance, design, materials, the evaluation of the design, manufacture, sterilization, packaging, and the information the maker supplies. More specific standards, such as those for joint replacements and for implants that fix bones, build on it.

Who uses it: Implant makers and designers, test laboratories and regulators; researchers in biomaterials and tissue engineering; and students.

Why it matters: It joins the materials and their biological evaluation, the subject of ISO 10993-1, to the finished implant: what has to be shown before an implant can be used safely in the body. For biomaterials and tissue engineering, it is the frame into which the more specific implant standards fit.

PaidWhere to get it

ISO 15223-1

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Current edition: ISO 15223-1:2021 and Amd 1:2025

ISO 20417

Medical devices — Information to be supplied by the manufacturer

Current edition: ISO 20417:2026

ISO 15223-1 brings together the symbols used on device labels and packaging, such as those for “use by”, “do not reuse” and “consult the instructions for use”, so that key information needs no words. ISO 20417 sets out what information a maker supplies with a device: on the label, in the instructions for use and on the packaging.

Who uses it: Device makers and regulators, and everyone who reads a device label, in a medical center or at home.

Why it matters: Reading a label correctly prevents mistakes, such as using an expired sterile product, or a single-use device twice. For anyone curious, these two are also the friendliest way into the world of standards.

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IEC 62366-1

Medical devices — Part 1: Application of usability engineering to medical devices

Current edition: IEC 62366-1:2015+AMD1:2020

Usability engineering: how a maker studies who will use a device, where and how, finds the ways they could make mistakes, and designs and tests the device so that those mistakes become less likely. It works hand in hand with risk management.

Who uses it: Device makers, designers and human factors specialists; and medical centers that report problems in use.

Why it matters: Many incidents with devices begin with a mistake in use, not a broken part. An engineer who knows this standard sees such problems as questions of design and training, not only of people’s errors.

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Running the medical center

Managing the health care organization as a whole: the quality of its care and of its laboratory, its assets and buildings, keeping its services going through a crisis, and the security of health information.

ISO 7101

Healthcare organization management — Management systems for quality in healthcare organizations — Requirements

Current edition: ISO 7101:2023

A management system standard for quality in a health care organization as a whole: care centered on the patient, leadership, planning, measuring and improving care, and the safety of patients and staff.

Who uses it: Managers of hospitals and clinics, quality teams, and staff who want to improve care.

Why it matters: It brings the quality thinking of the device world to the running of the medical center itself. It is new, published in 2023.

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ISO 15189

Medical laboratories — Requirements for quality and competence

Current edition: ISO 15189:2022

The quality and competence of medical laboratories: impartiality and confidentiality; competent staff; suitable rooms, equipment, calibration and reagents; and sound processes before, during and after each examination, from the request and the sample to the report of the result, with attention to the risks to patients and to continual improvement. The 2022 edition also covers tests done near the patient, outside the laboratory (point-of-care testing), which used to have a standard of their own.

Who uses it: Medical laboratories, their managers and quality teams, the bodies that accredit them, and the clinicians who rely on their results.

Why it matters: Many decisions about a patient rest on a laboratory result. Accreditation to ISO 15189 shows that a laboratory’s results can be trusted. For a medical engineer, it also explains what a laboratory expects of its equipment: calibration, maintenance, verification and records.

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ISO 55001

Asset management — Asset management system — Requirements

Current edition: ISO 55001:2024

ISO 55000

Asset management — Vocabulary, overview and principles

Current edition: ISO 55000:2024

Asset management standards: how an organization protects or increases the value of its assets, such as buildings and equipment, throughout their working life. ISO 55000 explains the principles and the terms; ISO 55001 sets the requirements for an asset management system: a policy and objectives linked to the organization’s goals, plans, decisions that weigh cost, risk and performance, and continual improvement.

Who uses it: Managers of organizations with many physical assets, such as hospitals, utilities and transport; in a medical center, its managers and its engineering and maintenance teams.

Why it matters: A medical center’s devices and buildings are its assets. ISO 55001 ties their care to the center’s goals, so that buying, maintaining and replacing are decided with the whole life of each asset in mind, not one budget year at a time.

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ISO 41001

Facility management — Management systems — Requirements with guidance for use

Current edition: ISO 41001:2018 and Amd 1:2024

Facility management: the services that keep a building and the people in it working, such as the upkeep of the building and its systems, cleaning, security, energy and space. ISO 41001 sets the requirements for a management system for facility management, linking these services to what the organization needs.

Who uses it: Facility and property managers, hospital managers, and the companies that provide these services.

Why it matters: A hospital depends on its building as much as on its devices. Its electricity, medical gases, ventilation and water all come through the building’s systems. ISO 41001 helps the hospital manage these services with the same discipline it applies to its medical equipment.

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ISO 22301

Security and resilience — Business continuity management systems — Requirements

Current edition: ISO 22301:2019 and Amd 1:2024

Business continuity: how an organization prepares to keep its most important activities going through a disruption, such as a power outage, a flood, a fire, an epidemic or a cyberattack, and to recover afterwards. It sets the requirements for a management system: finding what matters most and how quickly it must be restored, planning, exercising the plans and improving them.

Who uses it: Managers of hospitals and clinics, emergency and safety teams, and engineering and IT staff.

Why it matters: A hospital cannot simply close when something goes wrong. Engineers play a large part in its continuity: backup power, spare devices, and plans for when a critical system fails.

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ISO 27799

Health informatics — Information security controls in health based on ISO/IEC 27002

Current edition: ISO 27799:2025

Information security in health care: how the controls of ISO/IEC 27002, the general guide to information security controls, apply to personal health information, so that it stays confidential, accurate and available to those who need it.

Who uses it: Health care managers, IT and security staff, and the teams responsible for patient records and data protection.

Why it matters: Health information is among the most sensitive data there is, and medical devices create and store more of it every year. ISO 27799 helps a medical center protect it, alongside IEC 80001-1 for connected devices.

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Which standard would you reach for?

Twelve situations from a medical center. For each one, choose the standard that helps most.

Question 1 of 12

Your team has repaired an infusion pump. Before it goes back to the ward, which standard describes the safety tests to do?
The hospital wants to connect its patient monitors to the hospital network. Which standard helps manage the risks?
A box of sterile dressings carries a symbol you don’t recognize, next to a date. Where would you look it up?
A supplier says it is certified to ISO 13485. What does that tell you?
Your medical center is setting up a planned maintenance program for its reusable devices. Which document describes how to run one?
A long power outage or a flood could stop your hospital’s operating rooms for days. Which standard helps plan how to keep essential services going?
Two ventilators do the same job. One costs less to buy, but its parts and maintenance cost more. Which standard helps compare their costs over their whole life?
A device maker asks for remote access over the internet to service your MRI scanner. Which document deals with the security of such remote maintenance?
Your hospital is building a new operating room, and its outlets will be fed from an isolated supply, so that a first fault only sounds an alarm instead of cutting the power. Which standard sets the rules for the room’s electrical installation?
Your hospital’s laboratory is preparing for accreditation. Which standard sets the requirements for its quality and competence, from its staff to the calibration of its equipment?
Your hospital decides each year, budget by budget, which devices to buy, repair or replace. It now wants these decisions to follow its goals and to take the whole life of each device into account. Which standard sets the requirements for such an asset management system?
Your hospital is setting rules on who may see patient records and how they are kept safe. Which standard shows how information security controls apply to health information?

Where to get each standard

Each standard from its official publisher: in English from ISO or the IEC, which sell them, and in Persian from INSO or in Arabic from GSO where an official edition exists. A national edition may follow an earlier international edition; the (i) beside it shows which.

StandardWhere to get itAccess
Quality and risk
ISO 13485:2016 (its card)English editionEnglish edition: Paid
Persian editionINSO-ISO 13485 based on ISO 13485:2016Persian edition: Free
Arabic editionGSO ISO 13485:2016 based on ISO 13485:2016Arabic edition: Paid
ISO 14971:2019 (its card)English editionEnglish edition: Paid
Persian editionINSO 12136 based on ISO 14971:2019Persian edition: Free
Arabic editionGSO ISO 14971:2024 based on ISO 14971:2019Arabic edition: Paid
ISO 31000:2018 (its card)English editionEnglish edition: Paid
Persian editionINSO 13245 based on ISO 31000:2018Persian edition: Free
IEC 31010:2019 (its card)English editionEnglish edition: Paid
Persian editionINSO 14560 based on IEC 31010:2019Persian edition: Free
Electrical safety
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (its card)English editionEnglish edition: Paid
Persian editionINSO 3368-1 based on IEC 60601-1:2005Persian edition: Free
IEC 60601-2-1:2020 (its card)English editionEnglish edition: Paid
Persian editionINSO 3368-2-1 based on IEC 60601-2-1:2009+AMD1:2014Persian edition: Free
IEC 62353:2014 (its card)English editionEnglish edition: Paid
Persian editionINSO 15522 based on IEC 62353:2014Persian edition: Free
IEC 60364-7-710:2021 (its card)English editionEnglish edition: Paid
Persian editionINSO 1937-7-710 based on IEC 60364-7-710:2021Persian edition: Free
Equipment in the medical center
ISO/TS 5137:2026 (its card)English editionEnglish edition: Paid
IEC 60300-3-14:2024 (its card)English editionEnglish edition: Paid
Persian editionISIRI-IEC 60300-3-14 based on IEC 60300-3-14:2004Persian edition: Free
IEC 60300-3-11:2009 (its card)English editionEnglish edition: Paid
Persian editionISIRI-IEC 60300-3-11 based on IEC 60300-3-11:2009Persian edition: Free
IEC 60300-3-3:2017 (its card)English editionEnglish edition: Paid
Persian editionISIRI-IEC 60300-3-3 based on IEC 60300-3-3:2004Persian edition: Free
IEC 80001-1:2021 (its card)English editionEnglish edition: Paid
Persian editionISIRI-IEC 80001-1 based on IEC 80001-1:2010Persian edition: Free
ISO/TS 11633-1:2026 (its card)English editionEnglish edition: Paid
Persian editionINSO 16289-1 based on ISO/TR 11633-1:2009Persian edition: Free
Materials, labels and use
ISO 10993-1:2025 (its card)English editionEnglish edition: Paid
ISO 14630:2024 (its card)English editionEnglish edition: Paid
Persian editionINSO 18188 based on ISO 14630:2012Persian edition: Free
ISO 15223-1:2021 and Amd 1:2025 (its card)English editionEnglish edition: Paid
Persian editionINSO 8629-1 based on ISO 15223-1:2016Persian edition: Free
Arabic editionGSO ISO 15223-1:2024 based on ISO 15223-1:2021Arabic edition: Paid
ISO 20417:2026 (its card)English editionEnglish edition: Paid
IEC 62366-1:2015+AMD1:2020 (its card)English editionEnglish edition: Paid
Persian editionINSO 12137-1 based on IEC 62366-1:2015Persian edition: Free
Running the medical center
ISO 7101:2023 (its card)English editionEnglish edition: Paid
ISO 15189:2022 (its card)English editionEnglish edition: Paid
Persian editionINSO-ISO 15189 based on ISO 15189:2022Persian edition: Free
ISO 55001:2024 (its card)English editionEnglish edition: Paid
Persian editionINSO-ISO 55001 based on ISO 55001:2014Persian edition: Free
ISO 55000:2024 (its card)English editionEnglish edition: Paid
Persian editionINSO-ISO 55000 based on ISO 55000:2014Persian edition: Free
ISO 41001:2018 and Amd 1:2024 (its card)English editionEnglish edition: Paid
Persian editionINSO 20597 based on ISO 41001:2018Persian edition: Free
ISO 22301:2019 and Amd 1:2024 (its card)English editionEnglish edition: Paid
Persian editionINSO 11311 based on ISO 22301:2019Persian edition: Free
ISO 27799:2025 (its card)English editionEnglish edition: Paid
Persian editionINSO 13220 based on ISO 27799:2016Persian edition: Free

Links and editions last checked:

Where to start learning

Editions change. Before relying on a standard, check its current edition on the publisher’s page.

Last reviewed by Ali TizMaghz on .

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