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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.

Medical devices Quality management systems Requirements for regulatory purposes
Published: 25-Feb-2016
Medical devices Application of risk management to medical devices
Published: 10-Dec-2019
Set of Standards recognized essential principles of safety and performance of medical devices
Sterilization of health care products
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published: 17-Aug-2018
Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performance requirements for micro-organisms risks
Published: 12-Oct-2016
Protective clothing — General requirements
Published: 04-Jul-2013
Medical devices Guidance on the application of ISO 14971
Published: 16-Jun-2020
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices Part 1
Published: 06-Jul-2021
Medical devices — Information to be supplied by the manufacturer
Published: 13-Apr-2021
Reprocessing of reusable medical devices and other devices in health and non-health related facilities
Published: 15-Dec-2023
Health records Digitized health records
Published: 24-Jul-2019
Technical systems and aids for people with disability
Published: 16-Oct-2015
Vendor Credentialing for Healthcare Facilities
Published: 12-Apr-2018
Management programs for medical equipment
Published: 31-Oct-2012
Breath alcohol testing devices
Published: 28-Jun-2019
Health records Paper health records
Published: 24-Jul-2019
Management of clinical and related wastes
Published: 21-Dec-2018
Standard Specification for Barrier Face Coverings
Published: 15-Mar-2024
American National Standard for Occupational an Educational Personal Eye and Face Protection Devices
Published: 13-Apr-2020
Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
Published: 06-May-2009
Fundamental aspects of safety standards for medical electrical equipment
Medical electrical equipment - ALL PARTS
Published: 09-Jan-2024
Medical devices - Part 1: Application of usability engineering to medical devices
Published: 17-Jun-2020
Access medical device Standards with ease

Essential Safety and Quality Standards for Medical Devices

Medical device safety and quality Standards are fundamental for ensuring that devices meet rigorous requirements for reliability and patient safety. These Standards encompass various elements, including electrical safety, alarm system protocols, and battery Standards, providing a robust framework to minimise risks and improve device performance. Compliance with these Standards helps manufacturers meet global regulations, supporting the safe use of medical devices across different healthcare settings and instilling confidence in healthcare providers and patients alike. Popular Standards include:

  • ISO 14971:2019 - Medical devices — Application of risk management to medical devices
  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes
  • ISO 10993-1:2018 - Biological evaluation of medical devices Part 1
  • ISO 18562-1:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1


Medical Device Design and Manufacturing Standards

Standards for the design and manufacturing of medical devices guide manufacturers in creating products that are both safe and functional. Design Standards address requirements for usability, safety, and compatibility, while manufacturing Standards ensure consistent quality during production. These Standards also incorporate best practices in engineering, helping to streamline the production process while maintaining high levels of safety and compliance. By adhering to these Standards, manufacturers can produce devices that meet international expectations and are fit for use in diverse medical environments. Popular Standards include: 

  • ISO 11607-1:2019 - Packaging for terminally sterilized medical devices
  • ISO 14160:2020 - Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices
  • ANSI/AAMI ST90:2017(R2024) - Processing of health care products—Quality management systems for processing in health care facilities
  • ISO 14708-5:2020 - Implants for surgery — Active implantable medical devices — Part 5

 

Medical Device Testing

 

Medical Device Software, Cybersecurity, and Validation Standards

As medical devices integrate more advanced software, cybersecurity and software validation have become crucial elements of industry Standards. Software Standards define protocols for development and testing, ensuring reliability and accuracy in device operation. Cybersecurity Standards protect devices from unauthorised access, securing sensitive patient data and maintaining device integrity. Validation Standards confirm that device software performs as intended, providing a secure and efficient framework for use in healthcare settings and addressing the critical importance of data protection. Popular Standards include: 


Medical Device Packaging, Labelling, and Compliance Standards

Packaging, labelling, and compliance Standards ensure that medical devices are clearly identified, safely stored, and accessible for healthcare professionals and patients. Labelling Standards provide essential information, such as usage guidelines, safety warnings, and regulatory details, while packaging Standards protect devices during transport and storage. Compliance Standards ensure that devices meet all applicable national and international regulations, supporting manufacturers in delivering devices that adhere to high safety and usability criteria. Together, these Standards help streamline the distribution and use of medical devices across healthcare markets. Popular Standards include: 

  • ISO 3826-2:2008 - Plastics collapsible containers for human blood and blood components — Part 2
  • ISO/TS 82304-2:2021- Health software — Part 2: Health and wellness apps — Quality and reliability
  • ASTM D 6603 : 2019 - Standard Specification for Labeling of UV-Protective Textiles
  • ISO 15223-2:2010 - Medical devices — Symbols to be used with medical device labels

 

Medical Device packaging

 

Testing, Risk Management, and Reliability Standards for Medical Devices

Reliability and risk management Standards for medical devices cover essential testing processes that ensure product durability, stability, and consistent performance. Testing Standards define protocols for verifying device functions and resilience, while risk management Standards guide the identification and mitigation of potential hazards. By implementing these Standards, manufacturers can proactively address device risks and enhance reliability, reducing the chance of failures in clinical settings and promoting patient safety. This rigorous approach to testing and risk management supports the production of dependable medical devices that maintain high Standards of quality and safety throughout their lifecycle. Popular Standards include: 

  • ISO 7405:2018 - Dentistry Evaluation of biocompatibility of medical devices used in dentistry
  • ISO 10993-17:2023 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
  • AS ISO 20776.2:2024 - Clinical laboratory testing and in vitro diagnostic test systems
  • ISO 21649:2023 - Needle-free injection systems for medical use — Requirements and test methods

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