Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert
Medical Devices Standards

Medical Devices Standards

Medical devices made to a Standard

Organisations within the medical devices industry have a responsibility to meet safety and quality requirements, to ensure safe use for the end consumer. 

The industry is demanding, where innovation is essential to keep moving forward with medical services, procedures and care. While striving to create better, safer and more reliable products and services, all current and future projects must work towards meeting the regulatory requirements. 

Standards help guide organisations through all business functions, including product development, quality assurance, management strategies and even cost efficiencies. 

It's important to remember that compliance within the medical devices industry means much more than just ticking boxes. It can mean crucial differences of the performance of a product or service, directly affecting the end consumer. Being able to rely on safe, standardised, and predictable devices that meet the required Standards can shorten development and production times, allowing for swift solutions in a variety of circumstances.

Popular medical device Standards


ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14971:2019 Medical devices - Application of risk management to medical devices
ISO 16142 series Set of Standards recognized essential principles of safety and performance of medical devices
ISO 11138 series Sterilization of health care products
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performance requirements for micro-organisms risks
ISO 13688:2013 Protective clothing General requirements
ISO/TR 24971:2020 Medical devices Guidance on the application of ISO 14971
ISO 17664-1:2021 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
ISO 20417:2021 Medical devices Information to be supplied by the manufacturer
AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organizations
AS/NZS 4815:2006 Office-based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
AS 2828.2:2019 Health records Digitized health records
AS/NZS 10542.1:2015 Technical systems and aids for people with disability - Wheelchair tiedown and occupant-restraint systems Requirements and test methods for all systems (ISO 10542-1:2012, MOD)
AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
AS 5182:2018 Vendor Credentialing for Healthcare Facilities
AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
AS/NZS 3551:2012 Management programs for medical equipment
AS 3547:2019 Breath alcohol testing devices
AS 2828.1:2019 Health records Paper health records
AS 3816:2018 Management of clinical and related wastes
ASTM F 3502:2023:REV A Standard Specification for Barrier Face Coverings
ANSI/ISEA Z87.1:2020 American National Standard for Occupational an Educational Personal Eye and Face Protection Devices
EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
IEC 60601-1:2023 SER Medical electrical equipment - ALL PARTS
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices




Access medical device Standards with ease

Related Blogs

Health Care Technology

Health Care Technology

Search ICS Category Code 11

Ultimately, health care technology focuses on improving services, products and treatments. Standards assist by setting industry best practice approaches, test methods, framework for management systems & strategies.


The Power of Predictability in Medical Devices

Predictability in challenging times within the MedDev industry

Challenging times arise from unpredictable circumstances. Predictability usually translates into low risk situations, whereas unpredictability usually translates into varying types of risk (including residual or inherent risks).

Understanding ISO 14971 2019

Understanding ISO 14971:2019

The medical device risk management Standard

The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.


Control the Spread of Infection

Three Important standards in healthcare and medical industries

In hazardous conditions, such as the potential for the spread of infection, the use of specific Standards can assist in guiding businesses and individuals in best practices for controlling the spread.

MDR 2021

Understanding the delay of MDR2020

The Medical Devices Regulation 2020

The transition started in May 2017, and was due to finish in May 2020. There has been an enormous global effort across the industry to meet the new regulations by it's May 2020 deadline, when all previous MDD will become void.

Medical Devices Regulatory Obligations

Medical Devices Regulatory Obligations

Staying compliant in the medical device industry

Continuing to meet your regulatory obligations means ensuring that your organisation is always using up-to-date and current Standards. i2i can help those in the MedDev space to stay compliant past the short-term focus on the EU MDR 2021 deadline.

Quality Management Systems in Medical Devices

Quality Management Systems in Medical Devices

ISO 13485 specifies requirements for a comprehensive QMS

ISO 13485 is the internationally recognised Standard to assist those specifically in the Medical Devices industry to create a quality management system (QMS) that helps ensure safe and high-quality products are delivered.

Medical device labelling

Medical Device Labelling

Medical device manufacturers obligations

Medical device labelling requirements are essential to meet regulatory and compliance obligations and assist with the safe use of the device.

Medical Industry and Device Standards

Medical Industry and Device Standards

Medical device quality management systems

Medical devices are created and used to provide care and services to those who require it. Their role is to assist with the health, wellbeing and safety of everyone involved. Standards are essential to ensure products and services meet benchmarks.

Securing Healthcare Records and Privacy

Securing Healthcare Records and Privacy

A need for standardised patient information security

As the world of technology pushes the boundaries and possibilities within healthcare, a standardised approach to handling, storing and accessing medical data needs to move at the same pace.

Medical Devices Quality Requirements

Medical Devices Quality Requirements

MDR impact on Quality Management Systems

With the medical device industry working hard to update their processes and products to comply with the new MDR regulations, a key focus within the industry needs to be keeping up with quality requirements during this transition.

Guiding safe and Sterile Environments in Healthcare

Guiding safe and Sterile Environments in Healthcare

Standards providing guidance in healthcare

As we are all still getting used to living in a world with COVID-19, sterilising techniques are under the spotlight. To help ensure the safety of healthcare workers, patients and broader community, we all need to do our part to stop the spread.

EU MDR 2020 Transition

Is EU MDR 2020 the Brexit of the Med Dev industry?

EU MDR 2020 Transition

With the looming deadlines and constant headlines talking about the coming changes, the parallels between EU MDR 2020 and Brexit are uncanny.

Medical Devices Product Development

MedDev Product Design to Product Development

Managing production design to development risks in the industry

As regulations are enforcing stricter standards for safety and quality, there is a critical need to have a comprehensive Standards Management system in place to provide access to Standards and technical documents at each stage of the process.

Standards Management

Standards Management

Adopt a powerful, user-friendly Standards Management solution

i2i is a cloud-based, configurable and secure platform for the storage, retrieval and distribution of your Standards, policies and technical documentation

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more