EBOOK
ULTIMATE LIST OF ISO STANDARDS FOR RMEDICAL DEVICES
TOM RISH MANAGER MEDICALDEVICE GURU GREENLIGHTGURU
ULTIMATE LIST OF ISO STANDARDSFOR MEDICALDEVICES
TABLEOFCONTENTS
2 OVERVIEW 14 ISO 10993-BIOLOGICAL EVALUATION OF MEDICAL 25 ISO19223 24ISO 141173 ISO 13485 DEVICES ISO/IEEE 11073-10101ISO 14971 IEC 62304 14 ISO 10993-1 26 ISO 13482 254 4 IEC 62366-1 ISO 10993-2 ISO 18113-15 ISO 11135 16 ISO 10993-4 27 ISO 226106 ISO 15223-1 16 ISO 10993-5 ISO 236406 ISO 80369-1 17 ISO 27186 28ISO 237477 ISO 11607-1 17 ISO 15194 28ISO 286207 ISO 11607-2 18 ISO15583- WASHER-DISINFECTORS 29 ISO 14708IIMPLANTS8 ISO 11137-1 18 ISO 15883-1 FORSURGERY-ACTIVE IMPLANTABLE MEDICAL9 ISO 14155 19 ISO 15883-2 DEVICES9 ISO 19001 ISO/TR 24971 19 ISO 15883-5 29ISO14708-110 10 ISO 11737-2 20 ISO 9626 ISO 14708-211 ISO 16571 20 ISO 11117 30ISO 14708-511 ISO 20916 21 ISO16142-1 31 ISO IEC 80001-1 22 ISO 16142-2 ISO 17664-1 31 ISO 22442-112 IEC/TR 80002-1 22 ISO 17664-213 IEC/TR 80002-2 ISO 12052
13 IEC/TR80002-3
OVERVIEW
The International Standardization Organization (ISO) is an independent non-governmental organization that has created thousands of international standardsfor numerous industries including medical devices.
ISO standards are voluntary consensus-based documents that provide guidanceon particular aspects of technology and manufacturing. For medlical devicemanufacturers ISO standlards are critical not only to building high-quality medlicaldevices but to remaining pliant with regulatory requirements while doing so.
ns sapoq oteinba a paziuooai aie spiepues oi uew asneoaq seuas the Food and Drug Administration (FDA) in the US or have been harmonizedwith regulations in other parts of the world such as the European Union. So even though ISO standards do not have the force of law they are essentialguides for medical device and in vitro diagnostic device panies.
Below you'll find a list of the most searched for and widely applicable ISOstandardls for medical devices. While this list doesn't include every ISO standardinclude some of the most important standards for building safe and effectivemedical devices-all in one place.
Use this list to quickly and easily find up-to-dlate ISO standards that apply to yourdevice. Happy scrolling!
ISO13485IMEDICALDEVICES-QUALITYMANAGEMENT SYSTEMS-REQUIREMENTSFORREGULATORYPURPOSES
Edition:3
Publication Year: 2016
Technical Committee: ISO/TC 210 Quality management andcorresponding general aspects for medlical devices
FDA recognized consensus standard? No
ISO 13485 specifies the requirements for a medical device manufacturer’s qualitymanagement system (QMS). The standard outlines the QMS requirementsnecessary to prove that the manufacturer is able to produce safe and effectivemedical dlevices that meet user needs and ply with all applicable regulations.
ISO14971IMEDICALDEVICES-APPLICATIONOFRISK MANAGEMENTTOMEDICALDEVICES
Edition: 3
Publication Year: 2019
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medlical devices
FDA recognized consensus standard? Yes
ISO 14971 specifies the process for risk management of medical devices
software as a medical device (SaMD) and in vitro medical devices. The standardoutlines a process for medical dlevice manufacturers to identify hazards evaluatethe risks associated with them and implement risk controls. Risk management as
defined within the standlard applies to all stages of the medlical device lifecycleand should be an ongoing process.
IEC62304IMEDICALDEVICESOFTWARE-SOFTWARELIFE CYCLEPROCESSES
Edition:1
PublicationYear:2015
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medical devices
FDA recognized consensus standard? Yes
IEC 62304 specifies a framework for the processes activities and tasks thatoccur throughout the lifecycle of medical device software. This standard definesthe lifecycle for Software as a Medical Device (SaMD) software as a ponent of a medlical device or software that is used in the production of a medicaldevice.
IEC62366-1IMEDICALDEVICES-PART1:APPLICATIONOF USABILITYENGINEERING TO MEDICALDEVICES
Edition:1
Publication Year: 2015
Technical Committee: ISO/TC 210 Quality management andcorresponding general aspects for medical devices
FDA recognized consensus standard? Yes
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