EN 14683 — Standard

About the Standard

Scope title: requirements and test methods for medical face masks

EN 14683 is a standard published by European Standard (EN) (EN). Standards published by the European standardisation organisations and adopted as national standards in member states; they are used as harmonised standards under EU directives.

See the other 194 codes from EN

Coverage areas

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that code EN 14683 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Medical device testing shows that a device is safe for the patient and the user and maintains its intended performance. In this family safety is not only about avoiding harm; a device failing to perform its expected function is also treated as a risk. A monitor missing an alarm or a pump delivering the wrong dose is directly a patient safety event.

At the centre of the field is RISK MANAGEMENT, and this is what sets medical apart from other sectors. The risk management process run under ISO 14971 also determines which tests are required. The test list is not copied from a table of standards; it is derived and justified from the device's intended use, the nature and duration of patient contact, the use environment and foreseeable misuse.

Assessment consists of several separate bodies of work, each with its own set of standards. Biocompatibility runs through the ISO 10993 series, electrical device safety through the IEC 60601 series, sterilisation through ISO 11135/11137/17665, packaging through ISO 11607, software through IEC 62304 and usability through IEC 62366. The quality system (ISO 13485) is the framework that binds these together.

Which tests are required is determined by the device's CLASS and its MODE OF CONTACT WITH THE BODY. A product in brief contact with skin and an implant entering the bloodstream do not go through the same test set; the scope is set by a biological evaluation plan prepared under ISO 10993-1. That plan justifies in writing which endpoints are required and why the others are not.

Packaging and sterilisation are taken as seriously as the device itself in this field. For a sterile device the packaging is not a transport container but the barrier that maintains sterility; if the barrier is breached, the device is no longer sterile. Packaging processes are therefore validated and shelf life is supported by real-time ageing data.

For devices containing software, assessment shifts from testing towards PROCESS assurance. IEC 62304 defines which development and verification steps must be followed according to the safety class of the software; the evidence is the traceability of the development process. Testing software does not make it safe — the process record does.

The clinical side is a separate column of the technical file. Test reports show that the device is technically safe; clinical evaluation establishes that the device delivers the intended clinical benefit and that the benefit-risk balance is acceptable. Neither replaces the other.

Method groups in this field

Biocompatibility
Cytotoxicity, irritation, skin sensitisation, systemic toxicity, haemocompatibility, genotoxicity and local effects after implantation. The required endpoints are set by the ISO 10993-1 plan.
Electrical device safety
IEC 60601-1 basic safety and essential performance; EMC, alarm, usability and environmental requirements through the collateral standards.
Sterilisation validation
Validation of sterilisation processes by ethylene oxide, radiation or moist heat; bioburden and sterility assurance level studies.
Packaging
Integrity of the sterile barrier system, seal strength, distribution simulation and shelf-life studies.
Microbiological tests
Bioburden determination, sterility testing, bacterial endotoxin and, where required, carrier validation studies.
Software and usability
IEC 62304 life cycle evidence and use-error focused evaluation under IEC 62366.

Commonly confused in this field

Cytotoxicity alone is not evidence of biocompatibility; the required set of endpoints is determined and justified according to ISO 10993-1.
An ISO 13485 certificate does not confer CE marking; classification under the MDR, the technical file and the notified body process run separately.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
A change of material (supplier, pigment, sterilisation method) may require the biological evaluation to be repeated; it is not a silent change.
An assessment made without the collateral and particular standards for IEC 60601-1 is incomplete; which -1-x and -2-x standards were applied must appear in the report.
In vitro diagnostic devices fall under the IVDR rather than the MDR, and laboratory equipment is often on the IEC 61010-1 side.

Which decisions these results support

MDR/IVDR technical file and notified body assessment
Completing the biological evaluation plan
Sterilisation and packaging validation
Determining shelf life and storage conditions
Determining the scope of reassessment after a design change

Structure of the Code

Published by: EN
Serial number: 14683
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Related Tests and Services

A separate test page based on this code has not yet been released. The code falls within the scope of the following test families.

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA, Saudi Arabia, China. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

2014/35/EULVDThe Low Voltage Directive. Governs the electrical safety of equipment operating in the 50–1000 V AC range; the manufacturer makes the declaration, with no notified body involvement.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Covers both the interference a device emits into its environment (emission) and its resistance to interference from outside (immunity).
(AB) 206/2012EcodesignEcodesign requirements for air conditioners and comfort fans. Sets minimum thresholds and a declaration obligation for seasonal efficiency and sound power level.
(AB) 626/2011Energy LabelEnergy labelling for air conditioners. The class on the label is based on measurement and is one of the first points examined in market surveillance.
(EU) 2024/573F-GasThe Fluorinated Greenhouse Gases Regulation. The refrigerant type and its GWP value directly affect the product's placement on the market and labelling obligation.
2011/65/EURoHSRestriction of certain hazardous substances in electrical and electronic equipment; an integral part of the CE declaration.
2000/14/ATOutdoor NoiseNoise emitted into the environment by outdoor equipment. Whether the outdoor unit falls within scope is assessed according to product type.
(AB) 2019/2021EcodesignEcodesign requirements for electronic displays. Includes on-mode power consumption, standby mode and repairability requirements.
(AB) 2019/2013Energy LabelEnergy labelling for electronic displays. Requires a separate class declaration for SDR and HDR modes and EPREL registration.
2014/53/EUREDThe Radio Equipment Directive. For a product with a radio interface, spectrum, EMC and electrical safety are assessed together; the 3.3(d)(e)(f) cybersecurity articles also apply.
2012/19/ABWEEEWaste electrical and electronic equipment. Requires product marking and registration with the collection system.
(AB) 2019/2020EcodesignEcodesign requirements for light sources. Covers efficiency, colour consistency, switching-cycle durability and product-information requirements.
(AB) 2019/2015Energy LabelEnergy labelling for light sources. An A–G class and EPREL registration are mandatory.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals. Creates a notification obligation for SVHC substances in the product's content.
(AB) 2019/1782Ecodesign (external power supplies)Ecodesign requirements for external power supplies. Sets minimum thresholds for loaded efficiency and no-load power consumption.
(AB) 2022/2380Common Charging InterfaceA common charging solution for certain radio equipment. Requires a USB-C interface and declaration of charging information on the label.
(EU) 2023/1542Batteries RegulationSustainability, safety and transparency for batteries. Carbon footprint declaration, recycled content and the battery passport apply on a staged timetable.
UN Manual of Tests and CriteriaUN 38.3Transport safety of lithium cells and batteries. The T1–T8 test series is applied in the defined order; shipment cannot proceed without a report.
(EU) 2023/988GPSRThe General Product Safety Regulation. Establishes a safety framework for aspects not covered by sector-specific legislation.
(EU) 2024/2847CRAThe Cyber Resilience Act. Cybersecurity requirements for products with digital elements; reporting from 11 September 2026, full application from 11 December 2027.
(AB) 1275/2008Ecodesign (networked standby)Minimum requirements for standby and off-mode power consumption in networked equipment.
(EU) 2022/2555NIS2 (indirect)Cybersecurity risk management for essential and important entities; a network-equipment supplier is affected through its customers' obligations.
(EU) 2016/679GDPR (indirect)Devices that process personal data incur a data-protection-by-design obligation.
(AB) 2023/1670Ecodesign (smartphones)Ecodesign requirements for smartphones and tablets. Sets requirements for durability, repairability, spare parts and software-update duration.
(AB) 2023/1669Energy Label (smartphones)Energy labelling for smartphones and tablets; battery life, drop resistance and a repair score are declared on the label.
(AB) 617/2013Ecodesign (computers)Ecodesign requirements for computers and servers. Includes requirements for annual energy consumption, standby mode and power management.
(AB) 2023/1804Alternative Fuels InfrastructureThe Regulation on the deployment of alternative fuels infrastructure. Governs connector type, payment and data-sharing requirements at public charging points.
2006/42/ATMachinery DirectiveRisk assessment, essential health and safety requirements and a technical-file obligation.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC, mandatory on 20 January 2027 with no further transition period.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(AB) 2023/1464Formaldehyde EmissionRestriction on formaldehyde emission from wood-based products (an amendment to REACH Annex XVII).
(EU) 2023/1115Wood and Forest ProductsThe Deforestation Regulation. A deforestation-free supply declaration for wood and derived products; 30 December 2026 for large operators.
(EU) 2024/3110Construction Products (fixed furniture)The Construction Products Regulation's scope is assessed for furniture permanently fixed to a building.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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