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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.

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

 

 

 

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