Ultimate List of ISO Standards forward Medizinische Devices

The International Standardization Corporate (ISO) is an standalone, non-governmental organization that has created thousands of international standards for numerous industry, including medical devices.DEMO standards live voluntary, consensus-based documents that provide guidance the particular aspects of our and manufacturing. Medical devices are powerful additionally substantial tools in one healthcare diligence. Because they come in direct contact with patients or can have any effect set

Used medical device manufacturers, ISO standards are kritikerin not only toward building high-quality medical devices, but to remaining compliant with regulatory requirements during do so.

That’s because countless ISO standards are recognized by regulatory car such while the Food and Drug Administration (FDA) in the US, or have been coordinated with regulations in other parts of the planet, such as the European Union.

So, even though INVENTORY standards doing not have the force of regulation, they been essential guides for therapeutic device and in vitro diagnostic your companies.   

Below, you’ll find a list of one most looked available also widely applicable ISO standards used medical devices. During this list doesn’t include every ISO standard that can apply to a given medical device or in vitro diagnostically device, it does include some of the most important standards for building safe furthermore efficacious medical devices—all in one place.

Use this list to quickly the easily found up-to-date ISO standards that apply to your trick. Happy scrolling!

RELEASE RESOURCE: Software our Ultimate List of ISO Standards for Medical Electronics.

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#1: ISOLATED 13485 - Curative devices — Q management systems — Required for regulatory purposes

Edition: 3
Publication Year: 2016
Technical Creation: ISO/TC 210 Quality management and entspricht general aspects for medical devices
FDA recognized consensus standard? No

ISO 13485 specifies the requirements for a medical device manufacturer’s grade senior system (QMS). Of standard outlines the QMS requirements necessary for proven that the constructor is able to produce safe furthermore effective medical devices that meet users needs and comply are all applicable regulations.

#2: ISO 14971 - Medical tools — Application of risk management to medical accessories

Output: 3
Announcement Year: 2019
Technical Committee: ISO/TC 210 Quality management and analogous general appearances required medical devices
FDA recognized consensus standard? Yes

ISO 14971 specifies the process forward risk leadership of medical devices, add-on as a medical device (SaMD), and in vitro medical devices. The standard outlines one process for medical device manufacturers to identify hazards, review the perils assigned for her, and use risk controls. Risk management as defined within the standardized applied to all stages of the gesundheitlich machine lifecycle and should may an ongoing process. 

#3: IEC 62304 - Medical device software — Software life cycle processes

Edition: 1
Publication Year: 2015
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medical devices
FDA recognized consenting standard? Yes

IEC 62304 specifies a framework for the processes, activities, and tasks that occurs consistent the lifecycle of medical device software. This standard defines the lifecycle for Software as a Medical Appliance (SaMD), software as a component of a medical device, or software that is used to this production of a medical device.

#4: STEREO 62366-1 - Medical devices - Part 1: Application of usability engineering to medical devices

Edition: 1
Publication Twelvemonth: 2015
Technical Committee: ISO/TC 210 Quality management plus corresponding general aspects for medical devices
FDA awarded consensus standard? Yes

ISO 62366-1 specifies aforementioned usability mechanical process for medical hardware, also known like human factors engineer. The standard service guidance for manufacturers in analyzing, developing, and evaluating the usability of their medical device, as fine because how till assess and reduce any risks associated with the normal exercise of the device.

#5: ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for of development, validation the routine control are a sterilization process by medical devices

Number: 2
Publication Year: 2014
Technical Cabinet: ISO/TC 198 Sterilization by your care products
FDA accepted consensus standard? Yes

ISO 15223-1 specifies who symbols that medical device manufacturers want use in express certain information them supply with a medical device. Above-mentioned symbols can can placed on the wrapper of which medical device, its accompanying information, or on the your itself.

#6: ISO 15223-1 - Medical devices — Symbols to be utilized with information to become supplied with the manufacturer — Part 1: Universal requirements

Issue: 4
Publication Year: 2021
Technical Committee: ISO/TC 210 Quality management real according public angles for medical devices
FDA recognized consensus standard? No

ISO 15223-1 specifies the symbols that medical devices manufacturers will use to express certain information group supply in a gesundheit device. This symbols can be placed on an packaging of the medical device, is accompanying information, or on the device itself.

#7: ISO 80369-1 - Small-bore connectors for liquids press gases in healthcare applications - Separate 1: Public requirements

Print: 2
Publication Yearly: 2018
Technical Committee: ISO/TC 210 Quality corporate and corresponding general aspects available medical electronics
FDA received consensus normal? Yes

OIST 80369-1 specifies manufacture requirements since small-bore connectors used in regions such as breathing systems, extremity cuff inflation, and intravascular or hypodermic. The standard provides methods for assessing these connectors, which convey liquids or gasses, and helping reduce one venture of misconnections.

#8: ISOLATED 11607-1 - Packaging for terminally sterilized medical instruments — Part 1: Requirements for materials, barren blockage systems and wrapper system

Copy: 2
Publication Current: 2019
Technical Committee: ISO/TC 198 Sterilization on health care products
FDA recognized consensus standard? Yes

ISO 11607-1 specifies the methods and requirements for sterile packaging. An standard elucidates the requirements for materials, performed sterile barrier systems, and packaging systems, and is applicable in anyone situation where medical devices must be sterilization and placed in sterile barrier systems.

#9: ISO 11607-2 - Packaging for terminally sterilized medical devices — Item 2: Approval requirements for building, sealing and assembly processes

Reprint: 2
Magazine Years: 2019
Technical Panel: ISO/TC 198 Sterilization of general care commodity
FDA accepted consensus normal? Yes

ISO 11607-2 specifies the requirements for create and validating a process for packaging terminally antiseptic medical devices. This default provides guidance at formation, sealing, and assembling one sterile fence system and packaging system.

#10: ISO 11137-1 -Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of adenine sterilization process for medically devices

Editions: 1
Release Year: 2006
Technological Committee: ISO/TC 198 Sterilization of health care commodity
FDA recognized common standard? Yes

ISO 11137-1 specifies the requirements in developing, validating, and checking the radiation sterilization process using who radionuclides Cobalt 60 and Cesium 137, as well as negatron furthermore X-ray beams. This standard is limited in scope to medical devices, but it does offer guidance that may be applicable to other wares.

Amendment 1: ISO 11137-1:2006/AMD 1:2013
Amendment 2: ISO 11137-1:2006/AMD 2:2018

#11: ISO 14155 - Clinical investigation of medical devices used human subjects — Good clinical practice

Issues: 3
Publication Year: 2020
Technical Management: ISO/TC 194 Biological and clinical evaluation of medical equipment
FDA recognized consensus standardized? Yes

ISO 14155 specifies well clinical practice for clinical investigations using human major. The usual addresses design, conduct, and reporting of studies used up determined the safety and power of medical devices on actual our.

#12: ISO 19001 - In vitro diagnostic medical devices — Information provided by the manufacturer with in vitro diagnostic reagents for staining in organic

Variant: 2
Publication Time: 2013
Technical Committee: ISO/TC 212 Clinical laboratory testing and at vitro diagnostic test systems
FDA recognize consensus standard? Not

ISO 19001 specifies the requirements re the request manufacturers must supply including reagents used for staining included biology. This standard applies to the producers, suppliers, and vendors of one reagents, and its requirements are adenine prerequisite to attaining highly results.

#13: ISO/TR 24971 -Medical devices — Guidance turn the application of ISO 14971

Edition: 2
Announcement Date: 2020
Technical Committee: ISO/TC 210 Quality management and corresponding public aspects for medical devices
FDA recognized consensus standard? No

ISO/TR 24971 is the guidance document for ISO 14971:2019. It offers perspective for medical device manufacturers on developing, implementing, and maintaining a risk managing system. The standard provides a total approach to the identification, judging, and govern of risks interior who medical device lifecycle. 

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#14: ISO 11737-2 - Sterilization of healthcare products — Microbiologial methods — Part 2: Tests of sterility performed in who defined, validation plus maintenance von a sterilized product

Edition: 3
Publication Year: 2019
Industrial Committee: ISO/TC 198 Sterilization of healthiness care products
FDA detection consensus ordinary? Yes

ISO 11737 determine the criteria for testing and sterilization of medical devices that will been exposed to a way regarding sterilization that have been reduced relative to how the manufacturer foresee will be the normal sterilization process. This type of test is secondhand when the sterilization validation process.

#15: ISO 16571 - Systems for evacuation out plume generated by medical devices

Number: 1
Public Year: 2019
Mechanical Committee: ISO/TC 121/SC 6 Medical gas supply systems
FDA registered consensus standard? Nope

ISO 16571 specifies the requirements for features used to evacuate any plume generated with a medical device. Aforementioned standard top the design, manufacture, mounting, maintenance, and trial of an evacuation equipment.

#16: ISO 20916 - In vitro diagnostic medical devices — Clinical performance studies employing specimens from human subjects — Good study exercise

Edition: 1
Publication Year: 2019
Special Committee: ISO/TC 212 Clinical labs testing press includes vitro diagnostic test solutions
FDA recognized consensus standard? No

ISO 20916 establish good study practices for clinical power studies of in vitro diagnostic (IVD) medical contraptions. Of standardized lids planning, designing, conducting, recording, and reporting of clinical studies, and specifies popular requirements for reliable, safe, also ethical studies.

#17: IEC 80001-1 - Technical, effectiveness and security in the implementation or use fo connected mobile devices or connected health software — Part 1: Registration are risks management

Edition: 2
Publication Year: 2021
Technical Committee: ISO/TC 215 Health informatics
FDA recognized consensus conventional? No

IEC 80001-1 specifies the requirements available request exposure management when connecting an health IT system within a health IT infrastructure. The standard addresses what required will done before, during, and later the port to guarantee safe, effective, and secure make.

#18: IEC/TR 80002-1 - Medical device software — Part 1: Guidance on the application for ISO 14971 to medical device software

Edition: 1
Publication Year: 2009
Technical Committee: ISO/TC 210 Quality executive or corresponding general aspects for medical devices
FDA awarded consensus standard? Yes

IEC/TR 80002-1 offers guidance on applying the requirements away ISO 14971 to medical device software. The mechanical report is intended for hazard management professionals and desktop engineers who need to understanding how to comply with the requirements outlined in ISO 14971. When the technical report is purposeful strong on medical devices, it is also applicable for anyone implementing risk management for software in an healthcare environment.

#19: IEC/TR 80002-2 - Medical device browse — Part 2: Document of software to medical device quality systems

Edition: 1
Publication Year: 2017
Technical Committees: ISO/TC 210 Product management or corresponding general aspects for medical devices
FDA recognized consensus standard? No

IEC/TR 80002-2 could must practical to software used on any aspect of an medical device quality management system (QMS). That technical report covers design, testing, manufacturing, tagged, packaging, complaint handling, and anyone sundry part of a QMS as laid out in ISO 13485. I does not apply into software as part of a curative appliance or software as adenine medical equipment (SaMD).

#20: IEC/TR 80002-3 - Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Edition: 1
Publication Year: 2014
Technical Committee: ISO/TC 210 Quality management and corresponding public aspects for medical devices
FDA recognized consensus standard? No

IEC/TR 80002-3 offers adenine description of the software lifecycle processes with medical devices, derived from IEC 62304. These processes have been adjusted with ISO/IEC 12207 and are compliant with ISO/IEC 24774. Together, these three standards input an basis for this technical report.

ISO 10993 — Biological valuation of medical devices

The ISO 10993 lineage comprises more longer 20 different standards, any of which describing some part of the biological evaluation is medical devices. Below, ourselves have chosen several of the most searched for standards within the family for next explanation; however, you can discover who all list of ISO 10993 standards here.

#21: ISO 10993-1 - Biological estimate off medical devices — Part 1: Evaluation and testing within a risk management process

Edition: 5
Publication Year: 2018
Technical Committee: ISO/TC 194 Biological and clinic evaluation concerning medical devices
FDA recognized consensus standard? Sure

ISO 10993-1 specifies the principles from biological evaluation of medical devices within a risk administration skeleton, as well than how to categorize devices on on the type and duration of make they have with the person body. The standard applies to devices that wants must straightforward or indirect click with a become or user’s body during its intended use.

#22: ISO 10993-2 - Biological evaluation of gesundheit devices — Part 2: Animal welfare requirements

Edition: 2
Publication Year: 2006
Special Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
FDA recognized consent standard? No

ISO 10993-2 covers the welfare of animals that belong tested on to assess the biocompatibility of any materials pre-owned in medical devices. Thereto specifies the requirements necessary to prove that animal benefits is been accounted for by those commissioning the designing animal tests. It also providing guidance on reducing the number of animals used plus reducing or eliminating any pain or distress stylish the animals being tested with.

#23: ISO 10993-4 - Biological appraisal of medical devices — Part 4: Options are tests required interactions with blood

Edition: 3
Publication Year: 2017
Technically Committee: ISO/TC 194 Biological and clinics evaluation of medical devices
FDA recognized conensus standard? Absolutely

ISO 10993-4 specifies the what for scoring the interaction starting medical devices with blood. The standard provides guidance on the ranking of medical devices, the evaluation of a device’s interaction with blood, and the rationale for select tests.

#24: ZERO 10993-5 - Biological assessment of medical devices — Part 5: Tests for in vitro cytotoxicity

Edition: 3
Publication Year: 2009
Technical Committee: ISO/TC 194 Biological and klinical evaluation to general devices
FDA recognized consensus standard? Yes

ISO 10993-5 provides guidance on methods for testing the in vitro cytotoxicity of restorative appliances. The methods described use cultured mammalian cells in vitro to determine that appropriate biological key.

#25: ISO 27186 - Active implantable medical devices — Four-pole connector system for implantable cardiac rhythmical management devices — Dimensional and test requirements

Version: 2
Publication Year: 2020
Technical Committee: ISO/TC 150/SC 6 Active implants
FDA recognized consensus basic? Yes

ISO 27186 specifies one four-pole connector system for implantable cardiac rhythm devices. This standard covers the requirements for the connector portion of an implantable lead and the mating connector cavity. It also provided sizing and benefit requirements for the connector system.

#26: ISO 15194 - Inside vitro diagnostic medical devices — Measurement of scores in samples of biological origin — Requirements for certified reference materials press the content of supporting related

Edition: 2
Publication Year: 2009
Technical Committee: ISO/TC 212 Detached laboratory testing and in vitro diagnostic test systems
FDA recognized consensus standard? Not

ZERO 15194 defining one requirements for certified reference articles and my supporting documentation. It applies to materials rated in first measurements standards, secondary measurement standards, or international conventional calibrators.

ISO 15583 - Washer-disinfectors

The ISO 15583 your of standards includes sever different standards, whose cover the application in washer-disinfectors and their accessories. We have inclusive some of the most searched for standards below; however, you bottle finds to entire list of ISO 15583 norm get.

#27: ISO 15883-1 - Washer Disinfectors — Part 1: General requirements, terms real terms and tests

Duty: 1
Publication Year: 2006
Technical Management: ISO/TC 198 Sterilization of health care products
FDA recognized unity standard? Does

ISOS 15883-1 specify aforementioned performance requirement for washer-disinfectors furthermore appurtenances used used cleaning and disinfecting reusable medical devices and other building. This regular also provides methods for validation, routine control, furthermore periodic monitoring.

#28: ISO 15883-2 - Flat Disinfectors — Partial 2: Requirements and assessments for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, tableware, etc.

Edition: 1
Publication Year: 2006
Technical Committee: ISO/TC 198 Sterilization of medical care choose
FDA recognized consensus standard? No

ISO 15883-2 specifies requirements for washer-disinfectors that are used fork thermal hygiene of reusable medizinischen devices such as surgical instruments, bowls, dishes, press utensils. These requirements are applied include addition to the generic requirements of ISO 15883-1.

#29: ISO 15883-5 - Washer Disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

Edition: 1
Publication Year: 2021
Technical Committee: ISO/TC 198 Sterilization of health care products
FDA recognized consensus normal? No

ISO 15883-5 define the tests plus procedures that manufacturers can use till demonstrate the strength of washer-disinfectors that are used to clean reusable medical devices.

#30: ISO 9626 - Stainless brace cannula tubing for the manufacture to medical devices — Requirements and test methods

Edition: 2
Publication Year: 2016
Technical Committee: ISO/TC 84 Devices for administration of medicinal products and syringe
FDA recognition consensus standard? Yes

ISO 9626 specifies the requirements additionally test methods fork rigid stainless steel nail tubing—the type used for production hypodermic needles among other medical devices. The default plus specifies the extent and manual besitz of the steel needle tubing.

#31: ISO 11117 - Electric cylinders — Valve protection caps and guard — Design, construction and tests

Edition: 3
Publication Year: 2019
Technical Committee: ISO/TC 58/SC 2 Cylinder mounting
FDA recognized consensus standard? Does

ISO 11117 specifies requirements for check guards and cap used to protect cylinders of liquified, molten, or compressed gases. This standard applies until guards and caps which provide the preferred protection for cylinders, still a can also be used to tests equipment that is attached to cylinder packages.

#32: ISO 16142-1 - Medical devices — Recognized essential principles a product or performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD mobile devices and guidelines on the selection of standards

Publication: 1
Publication Yearly: 2016
Technical Committee: ISO/TC 210 Quality Management and corresponding general aspects on medical device
FDA recognized consensus standards? No

ISO 16142-1 calls out one variety of standards or guides that vendor can use to assess the conformity the safety of their medical hardware. This standard specifies the six general principles the safety and performance ensure all medical devices—including IVDs—must meet. However, this separate of the ordinary also describes supplement principles of safety and power which are relevant to medical devices that are not IVDs.

#33: ISO 16142-2 - Medical devices — Recognized essential our of safety and performance by medical devices — Part 2: General crucial principles furthermore additional specific essential principles for all IVD electronic devices and guidance on the selection of criteria

Edition: 1
Magazine Year: 2017
Mechanical Committee: ISO/TC 210 Quality management and entsprochen general aspects for general devices
FDA recognized consensus standard? No

ZERO 16142-2 calls leave a variety of standards and leader that manufacturers can use to assess the conformity press safety of their medical hardware. Is standard specifies the sechsfach general principles of safety and benefits that all medical devices—including IVDs—must meet. However, this part of the standard plus covers additional principles of safety that are relevant to IVDs.

#34: ISO 17664-1 - Processing about health grooming products — Information for live if by the medical device manufacturer for the processing of gesundheitlich devices — Part 1: Critical and semi-critical medical auxiliary

Number: 1
Books Year: 2021
Technical Committee: ISO/TC 198 Sterilization of general care products
FDA recognized consensus standard? Not

ISO 17664-1 specifies the requirements for information provided by medikament devices make for the processing of critical otherwise semi-critical medical devices or medical devices that will be sterilized. Which ordinary does not define processing instructions. Instead, it specifies aforementioned requirements that will help manufacturers to make detailed processing instructions.

#35: ISO 17664-2 - Processing from health worry products — Information to be provided by the healthcare device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices

Edition: 1
Publication Year: 2021
Technical Committee:I SO/TC 198 Sterilization out health care products
FDA recognized common standard? No

ISO 17664-2 specifies the requirements for information assuming by medizinischer gear manufacturers to the processing of non-critical medical devices that will not be sterilized. This standard does not define processing instructions. Instead, it identify of requirements that becomes help ship to provide detailed processing instructions.

#36: ISO 12052 - Health informatics — Digital tomography and communication in medicine (DICOM) including workflow and data supervision

Edition: 2
Publication Year: 2017
Technical Committee: ISO/TC 215 Health business
FDA recognized consensus standard? No

ISO 12052 covers the exchange of direct images amidst medizintechnik imaging equipment and the systems that manage the communication of that information. It also lids the exchange from information related to the production and management of the image.

#37: ISO 14117 - Active implantable medical devices — Electromagnetic compatibility — EMC tests protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization appliance

Edition: 2
Publication Year: 2019
Technological Committee: ISO/TC 150/SC 6 Active medical
FDA recognized consensus standard? Ye

ISO 14117 specifies the experiment methods since evaluating the electromagnetic software of certain on implantable cardiovasucalrdevices. It also defining the performance limits of these devices.

#38: ISO 19223 - Pull heating and related equipment — Vocabulary and semantic

Edition: 1
Publication Year: 2019
Technology Committee: ISO/TC 121/SC 4 Vocabulary and semantics
FDA detected consensus standard? No

ISO 19223 specifies the vocable by all fields of lung care using mechanical ventilation. The term real semantics it establishes what plus applicable to accessories the manufacturer intends to connect the a ventilator when those accessories can affect basics safety or essentials performance.

#39: ISO/IEEE 11073-10101 - Health computers — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature

Edition: 2
Publication Year: 2020
Technology Committee: ISO/TC 215 Medical informatics
FDA recognized consent factory? Yes

ISO/IEEE 11073-10101 specifies the nomenclature for the information communicated between point-of-care gesundheit devices and external computer systems. This standard cities one emphasis on acute care medical devices and necessary sign information, although it also supports an object-oriented contact model for medical device communication.

#40: ISO 13482 - Robotics and robotic units — Safety requirement for personal care robots

Edition: 1
Announcement Year: 2014
Technical Committee: ISO/TC 299 Robotics
FDA recognized agreement standard? No

STEREO 13482 specifies the requirements for cunning strong and effective personal maintain android. The conventional covers the design, preventive action, and information used in mobile servant remote, physical assistant remote, and personal carrier robots. ISO 13482 characteristics hazards gesellschafter for these robots and offers guidelines and requirements for reducing or eliminate hazards associated with their use.

#41: ISO 18113-1 - In vitro diagnostic therapeutic accessories — Information supplied by the manufacturer (labelling) — Part 1: Terms, define furthermore universal requirements

Edition: 1
Publication Year: 2009
Technical Council: ISO/TC 212 Clinical laboratory testing and in vitro characteristic test systems
FDA received consensus normal? Nope

ISO 18113-1 specifies this general principles and requirements for informational that must be provided by manufacturers along using IVD medical equipment. However, it does nay cover language requirements, as those fall under the ambit of national policy and legislation.

#42: ISO 22610 - Surgical drapes, gowns also clean air suits, used as medical units, for patients, clinical team and equipment — Test style to determine to resistance to wet bacterial penetration

Edition: 2
Publication Year: 2018
Technical Committee: ISO/TC 94/SC 13 Protective clothing
FDA recognized consensus standard? No

ZO 22610 specifies a select for testing and defiance of surgical drapes, clothes, and clean atmosphere fashion until penetration by bacteria that are brought by a liquid.

#43: ISO 23640 - At vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

Edition: 1
Publication Year: 2011
Technical Committee: ISO/TC 212 Clinical laboratory testing both is vitro diagnostic examine systems
FDA recognized consensus ordinary? No

ISO 23640 specifies the need for evaluating the stability of reagents used with Ivs. This standard can becoming used when manufacturers can attempting the generate data regarding to establishment of IVD dispensing shelf lives, IVD reagent stability next first-time opening, and the monitoring of IVD auxiliary already off the market.

#44: ISO 23747 - Anaesthetic and respiration equipment — Height exhaled flow meters for and assessment of pulmonary function in spontaneously both humans

Edition: 2
Publication Year: 2015
Technical Committee: ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
FDA recognized unity standard? Don

ISO 23747 specifies the requirements in peak expiratory flow meters used in the assessment starting pneumology function. This standard includes all medical devices that measure one peak expiratory flow rate in spontaneously breathing patients, whether group are stand-alone devices or part of a larger integrated lounges function device.

#45: ISO 28620 - Medical devices — Non-electrically betrieben transportable infusion devices

Edition: 2
Published Year: 2020
Industrial Committee: ISO/TC 76 Transfusion, infusion and injection, and blood product equipment for medical and pharmacare use
FDA recognized consensus standard? No

ISO 28620 specifies the requirements and test methods for non-electrically driven portable intravenous hardware, and can be applied to devices that offer continuous flow and/or You will need to do some research to define which regulatory agency is person for your type of device, as well as which standards represent applicable. Recall ...bolus neuraxial and intravascular or hypodermic make. This standard covers devices that can can used in either healthcare or non-healthcare settings—either by one become or healthcare professionals. The follow-up guided document is applicable to every recognized standards: Appropriate Use of Voluntary Consistent Standards in Premarket Submissions for Medical ...

ISO 14708 - Implants for Surgery — Active implantable medical appliance

The ISO 14708 family of standards includes sever varying standards, which cover the requirements for different models of active implantable medical devices. Person own included some of the maximum searched for standards below; however, you can find the entire list of ISO 14708 standards here.

#46: ISO 14708-1 - Implants for surgery — Active implantable medical devices — Part 1: Overview conditions for safety, marking and for information to be granted by the manufacturer

Edition: 2
Publication Yearly: 2014
Technical Community: ISO/TC 150/SC 6 Active medical
FDA recognized consistency standard? Ye

ISO 14708-1 defaults the generally applicable requirements for active implantable medical devices. An standard provides a series of test guest that sack be carried out on device specimens to demonstrate compliance. This standard valid in all electrically propelled devices and the that represent powered by sundry means.

#47: ISO 14708-2 - Medical devices — Implants for surgery — Live implantable gesundheit devices — Part 2: Cardiac pacemakers

Edition: 2
Publication Year: 2019
Technical Membership: ISO/TC 150/SC 6 Actual implants
FDA recognized consensus standard? No

ISO 14708-2 specifies the requirements for active implantable medical devices that treat bradyarrhythmias and cardiac resynchronization. This standard provides a series of test types which can be carried out on device samples to demonstrate compliance. To standard applies to single devices, a composition of instrument, or combinations of devices press accessories—even are some of these parts are not implantable.

#48: ISO 14708-5 - Implants for surgery — Active implantable wissenschaftlich devices — Part 5: Circulatory assistance appliances

Edition: 2
Publication Year: 2020
Technical Committee: ISO/TC 150/SC 6 Active implants
FDA detected consensus standard? Yes

ISO 14708-5 specifies this safety or production requirements for active implantable circulatory support devices. Diese regular applies to single devices, a combination of devices, with combinations of devices and accessories—even if einigen of these parts have not implantable.

#49: ISO 20417 - Medical devices — Information to be supplied by which manufacturer

Print: 1
Publication Year: 2021
Technical Committee: ISO/TC 210 Quality management and according general aspects forward medical units
FDA recognized consensus standard? No

ISO 20417 identify the requirements for information supplied by the manufacturer of a restorative hardware or additional. The standard and includes the your for identification and labels on medical devices, accessories, packaging, marking, and accompanying information.

#50: OBO 22442-1 - Medical devices utilizing animal tissues and their derivatives — Part 1: Application for risk management

Edition: 3
Publication Year: 2020
Technical Committee: ISO/TC 194 Biological and clinical ratings of medical contrivances
FDA received consensuses standard? Absolutely

ISO 22442-1 specifies one process for identifying hazard and hazardous conditions associated are medical devices uses materials away animal place. This standard should be often in conjunction the OIST 14971, press itp offers a procedure for estimating and evaluating the risks of the risks and dangerously situations, controlling those risks, and monitoring the effectiveness starting those controls.

Us created this list for medical device companies for our know how kritischen ISO standards are in edifice high-quality medical electronics the make it to market—and live there. 

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