When you are sick and injured the last thing you want to worry about is the safety, quality and effectiveness of medical equipment and products.

We need international standards to protect the health and safety of patients and healthcare providers.

ISO standards mean different things to different stakeholders. For governments, standards are a fundamental technical basis for healthcare legislation, that ensures communities receive the quality of care they deserve. For healthcare organizations, standards are a harmonizing force that helps increase the effectiveness and reliability of medical care across countries. For manufacturers, standards make it easier to develop the products that the market needs.

International Standards are important to us all.

Are your health services up to standard?

Are your health services up to standard?

What if there were no standards in the health industry? Standards ensure things work, from keeping bugs at bay of our medical devices to making sure all the important medical information is clearly labelled.


How do standards contribute to better healthcare?

"Standards contribute to make the work of health professionals more effective and easy, and are instrumental for the efficiency of healthcare systems,” says Avelino Brito, Managing Director at AENOR, the ISO member for Spain. Find out what else standards do.

ISO and health brochure

ISO and health

We have over 1200 standards focusing on health in many sectors, from dentistry to medical devices, and health informatics to traditional medicines.

Health professionals

We need to set up an environment that ensures the best possible conditions for healthcare professionals to do their job.

An important role of international standards is making it easier for healthcare professionals to focus on what’s important - their patients. They do this by ensuring that medical devices are up to speed, that laboratory results are reliable and comparable, and much more.

One area where standards are making a difference is labelling. Standardized graphical symbols, for example, help professionals understand important information across language barriers. A new set of standards to unambiguously identify medicines across regions will improve transparency of medical product information and reduce medical error.

Medicine pills

The right medication for the right patient

Medication errors and adverse drug events can occur in nearly half of all surgical procedures, according to one study. Many are caused by mistakes in labelling, incorrect dosage and documentation errors. ISO can help.

Australian Health Professionals

Australian health experts on standards

Why do healthcare standards matter? These Australian health experts tell it like it is.

Identification of medicinal products

Medical experts from nearly 60 countries are working to develop five International Standards for the identification of medicinal products.

Traditional Chinese medicine

From healing herbs to pain-reducing acupuncture, Traditional Chinese Medicine takes a holistic approach to health and wellness, focusing as much on prevention as it does on treatment.

The 2015 Nobel Prize in Medicine took many by surprise, when it was awarded to a Traditional Chinese Medicine (TCM) expert for her landmark discovery of anti-malarial Artemisinin. This award was a huge leap for the industry, raising hopes of more mainstream recognition of traditional therapies.

There is currently a great risk of inferior practitioners and treatments in poorly regulated markets that can undermine public safety, and the reputation of TCM. An ISO committee developing TCM standards is poised to bring confidence and reliability to the field.

Old Chinese medicine book

Putting traditions to the test

Despite being in existence for so long, Traditional Chinese Medicine is still clouded in mystery and myths. Hereʼs one mystery revealed.

The 5 elements in Chinese medicine: Fire, Wood, Metal, Earth, Water

The five elements

What are the five elements of Chinese medicine and how do they manifest themselves in our bodies?

Ms. Amanda Gcabashe

Serving South Africa the Chinese way

Marrying TCM to modern medicine faces numerous challenges, but South Africa is taking a bold step forward in this direction.

Quality of medical devices

Quality and safety are non-negotiable in the medical devices industry. ISO 13485 intends to keep it that way.

Medical devices refer to the products used in the diagnosis, prevention and treatment of medical conditions, from wound dressings to life-support machines.

ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. The standard has recently been updated with improvements that broaden its applicability to all organizations involved in the life cycle of medical products, ensure greater alignment with regulatory requirements, and place more focus on post-market surveillance, including complaint handling, infrastructure and risk management.

Medical staff pushing a patient on a stretcher

The patient comes first

With medical devices ranging from simple needles to life-saving high-tech implants, how can we ensure the highest possible level of safety?

Test tubes

The new ISO 13485

All you need to know about the revised ISO 13485, a key standard for organizations working in the design, production, installation and servicing of medical devices and related services.


Ensuring healthy lives and promoting well-being for all ages is essential to sustainable development

Goal 3 of the United Nations Sustainable Development Goals focuses on good health and well-being. ISO standards contribute in many ways to this important milestone, not least by ensuring the devices and products we need to keep healthy, or recover from illness, work as intended.

For example, there are ISO guidelines for the delivery of telehealth services that ensure consistent, quality remote medical assistance, while safeguarding a client’s data. Similarly, standards can help regulate the effect on our body of light from electronic devices, shown in recent studies to have an adverse impact on sleep. These are just a few examples of how standards are looking out for us, but there are many more.

Light bulb

Things you need to know about health-centric lighting

Feeling tired this morning? Blame it on the light. In fact, light impacts our circadian rhythms more powerfully than any drug. Welcome to the world of "health-centric lighting" and find out how it affects you.

Illustration of effects of diabetes

What do you know about diabetes?

“Beat diabetes” is the theme of World Health Day 2016 (7 April). Did you know there is a standard for self-testing blood-glucose monitoring devices?

Learn more with this interactive infographic.

Woman pointing at a digital screen with health information

Telehealth for long distance care

Itʼs midnight and youʼre burning with fever and you would like a medical consultation right here at home. With telehealth you can, all it takes is a computer and you can soon back in bed resting with a prescription waiting to be filled.