F.A.Q.

If your products need US and Canadian safety approvals, you may be faced with the concern over which certification mark to use and what certification mark is acceptable in the U.S. and Canada. The myth that your choices are limited to certification marks issued by UL or CSA is false. To sell your product in the United States, a laboratory that is recognized by OSHA as a Nationally Recognized Testing Laboratory (NRTL) can certify your product. When your product bears a certification mark from an NRTL, you are telling the Authorities having Jurisdiction (AHJ) and consumers that it has been evaluated by a third party and found to comply with the applicable standards. Likewise, when you sell your product in Canada, the law requires that you have it approved by a Certification Organization (CO) accredited by the Standards Council of Canada (SCC). Once your product is evaluated against the applicable Canadian requirements, you can apply the Canadian certification mark to your product, showing it has been certified to the CSA standard(s).  F2 Labs can assist you in obtaining NRTL and SCC certification for your product.

Yes, but is important to remember that the liability for the accuracy and completeness of the testing always remains with you as the manufacturer or your importer.

Most manufacturers benefit from utilizing the services of an independent third-party test laboratory. F2 Labs are technical experts in evaluating products to the applicable harmonized standards so that manufacturers can CE mark their products.

Typically, if products are electrical similar with only minor differences, the manufacturer can determine a worst-case model that will go through the testing.  The report will then contain a statement that the other models are compliant by similarity according to the manufacturer. 

Potentially, any Part 2’s may modify testing that is being performed under the main standard.  These should always be addressed as part of the evaluation. 

REACH governs substances, mixtures, and articles. An article is defined by its physical characteristics rather than its chemical composition. 

• Example: A screw is an article.

• A solenoid valve is a complex article made of multiple articles.

• An engine is a complex article composed of other complex articles and individual articles.

REACH applies to a list of regulated substances, including lead, Diboron trioxide, cadmium, and melamine. 

Before January 5, 2021, companies had to report if they sent more than 1 ton per year of a Substance of Very High Concern (SVHC) at a concentration of 0.1% or higher (homogeneous level) to the EU.

However, the Waste Framework Directive (WFD) removed the 1-ton threshold, meaning that since January 5, 2021, any amount of an SVHC above 0.1% must be reported to the SCIP database, with no exemptions.

The importer (buyer) in the EU is responsible for the SCIP database submission, not the manufacturer.

If your company does not have an EU location, you cannot submit SCIP reports directly. Instead, you must provide the importer with:

1. An I6Z data file for submission, OR

2. A Bill of Materials (BoM), part counts, and supplier contact details to enable them to complete the report.

The WFD extends REACH by requiring detailed tracking of substances in products. It uses this data for regulatory reporting to ECHA (European Chemicals Agency), ensuring greater transparency in material composition for environmental and waste management purposes.

Common EM Emitters Testing.

Your device should be set up to operate as it would under normal operating conditions. Typically, it would be set up the same as it would be for 60601-1-2 testing.

It is up to the client to determine what mode(s) should be tested for Common EM Emitters testing. Essentially, the Common EM Emitters testing is just adding in other types of immunity testing. We recommend that you test in the same mode(s) as you would for 60601-1-2 testing. For example, AC mains while charging mode, Battery only mode, Standby, Operating, etc.

Since there is no formal standard, you will determine pass/fail (what is acceptable). Typically, we see the same pass/fail and EP being applied as what would be chosen for the 60601-1-2 testing. For example, is it acceptable for the device screen to glitch, is it unacceptable for the device to turn off, etc.

There is no set standard for this, nor is a test method called out in the FDA guidance. The FDA has and is currently accepting our reports and we perform this testing weekly for clients.

Your device will be subjected to the particular Common EM Emitter from a very close range. If your device is affected negatively (does not meet your declared pass/fail criteria or EP), we will continue moving the emitter back until it is no longer negatively affected. The distance would be recorded, and you would put this into your documentation/warnings. In your Risk File, this would become your risk mitigation.

Yes, the FDA has and is currently accepting our reports. We perform this testing weekly for clients.

You may do so, but we do not need it. We will collect the information we need to determine our test plan, which ultimately becomes part of the test  report. We will only need to know how the equipment will be set up, what your Pass/Fail criteria will be, and what modes are to be tested.

We do not see this happening during testing because we are able to ‘focus’ the interference on the device under test. If your support equipment was to be negatively affected, we would work to address it. How we do that would depend on how the interference is getting to the support equipment.

No – we consider this information to be proprietary.

We do not require a Test Plan. We will collect the information we need to determine the test plan, which ultimately becomes part of the test  report. If you do prepare a Test Plan, we recommend that you keep it simple – we will only need to know how the equipment will be set up, what your Pass/Fail criteria will be, and what modes are to be tested. The Risk mitigation cannot take place until after you have the results of the testing – it will become the safe distance warnings in your Documentation.

Common EM Emitters testing should still be considered because the FDA has required it on devices in the past. Even prior to use, they have stated that it is likely that a device would be subjected to these phenomena during shipping/other transport, and they want to ensure that it arrives working as intended and safely. It is difficult (if not impossible) to know these days everywhere these technologies are being used, and the use of these technologies is increasingly common. Our pricing does not change if any items are removed from the list for testing – so we recommend completing all of the testing.

You should tell the FDA that the frequencies and levels are to be chosen by F2 Labs who have done this testing many times. F2 Labs has had many customers submit these reports to the FDA and they have been accepted by the FDA. F2 Labs will perform the Common Emitters testing in a chamber using a Radiated Field Method, with the test equipment required to generate the necessary fields and waveforms. They will expose all sides of the product to the interference source one side at a time, to ensure all sides and areas of the product get exposed to interference source to observe if any degradations occur.

For RFID Immunity testing the FDA refers manufacturers to IEC 60601-1-2 Table 11 or AIM 7351731. We typically recommend completing AIM 7351731 in addition to the 60601-1-2 Table 11 testing because it is much more extensive/inclusive and better represents the actual RFID threats that exist (frequencies/modulations).

No – testing to Table 11 of IEC 60601-1-2 is still required. Table 11 outlines requirements specific to different healthcare environments. While the 30 kHz frequency is only applicable to medical equipment (ME) used in home healthcare settings (as indicated by the “a.)” symbol next to that frequency in Table 11), the other two frequencies—134.2 kHz and 13.56 MHz—are still required for all ME equipment, including devices used in professional healthcare settings, such as surgical operating rooms.

In short, devices intended for professional healthcare environments (like surgical settings) are not required to test the 30 kHz frequency, but the 134.2 kHz and 13.56 MHz frequencies must still be tested. We work closely with the FDA and are familiar with their expectations, so we can confirm that they specifically look for this table to be completed as part of the regulatory process.

Canada requires all products coming in that are AC powered to be listed or have a field label at least.

This does not apply to battery powered devices. If a medical device, they may still have to apply or submit to Health Canada (if they are required to, this is for them to figure out).

OSHA requires devices used in the workplace to be Listed.

The standard for field labeling (NFPA 790/791) requires that the Field Label be applied at the final installation site. However, sometimes exceptions are made, and the label can be applied elsewhere (the factory or at F2 Labs) for devices that are mobile, not permanently installed and where the installation method is not critical to safety. In this case, it is important to know that there is a (small) chance that the AHJ at the final location may not accept the U.S. Field Label because the address on the report does not match the installation location.

Annual Factory Inspections of 3rd Party Components

If a listed product contains an unapproved component(s), that component(s) needs to undergo annual testing to ensure it still meets the requirement of the standard. Sales is to issue a proposal for the annual testing, after checking with engineering to find out how long the testing will take. The proposal should be opened as an entirely new product number and not a cost increase or revision, as it creates confusion in deadline, project folders, etc. The body of the proposal should mention the listing project number.

F2 labs does not assist with MRI Conditional Assessments, however these are a couple of labs that specialize in this type of work. In case you find this helpful, I found a couple of places that specialize in this testing:

• Services for MR Safety and Compatibility (mri-safe.org)
• MRSTS Home (magneticresonancesafetytesting.com)

It is the responsibility of manufacturers of devices (“device firms”) to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate. See also Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA.

Choosing a test lab based on price alone can backfire and end up costing time and money if the testing is not done properly. Additionally, in recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs from numerous such facilities based in China and India. See also Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA.

The FDA encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data. Third Party labs that are part of the ASCA program, (such as F2 Labs), had to go through a thorough evaluation with the FDA to be approved. See also Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data | FDA.

As medical devices develop safety history by being on the market, the FDA recognizes that some are just really safe. So, they made some medical devices exempt from 510k submissions. When a device is exempt, the FDA makes it very specific about what they can claim and what they cannot.

Being exempt from 510k doesn’t mean they are exempt from the FDA regulations though. For example, design control, quality management system, validation and verification are all still requirements.

In leu of the 510k, they still must register their establishment as well as register and list their device.

It’s vague but CFR 21 subpart B (is the quality management system requirement, see below for link) – one thing that is required is verification and validation – so per FDA definition, verification is the safety and EMC testing that is required.

When they don’t do the testing even though they registered – you get what’s called a 483 that says these are the nonconformities – it’s a threat – FDA eventually can fine you if you don’t comply.

CFR – Code of Federal Regulations Title 21 (fda.gov) – Link to the FDA QMS regulations

Canada’s “FDA” is Health Canada – very similar to the FDA in terms of structure and classification of devices.

No – the 60601-1 evaluation can proceed, regardless of where they are in their internal process. This would result in two possible scenarios:

1. Most of the time the internal bench testing does not affect the labs safety results, so we would simply be ensuring that they have addressed it/plan to address it (their RMF might indicate “pending bench testing results”). In the end the responsibility is on the manufacturer (not the lab), to ensure this happens successfully.
2. ​If their internal activities could affect how a particular requirement out of the standard is handled, then we would be able to proceed, but could not complete the report until we received the final results/updated RMF. An example of this: the device is intended to provide heat to a person, and the internal manufacturers testing being done is to justify being able to raise the limits beyond what the standard states, then obviously we would need to wait for that before we could call it good/complete our report.

There is an FDA guidance that provides criteria and decision flowcharts for companies to follow when they make changes to a 510K cleared device. FDA relies on the company to follow this guidance to make a decision on whether they submit a new 510K or document the change.

Documenting a change can mean 2 things:

1. Use the change order process and just document the change there. An example of this would be the company has an end of life component that they have to replace but it does not effect the device or the intended use of the device, so the change order process is sufficient
2. Write a letter to file. A letter to file is strictly internal and is never sent to the FDA. The FDA does review a letter to file during their routine facility inspections and it is possible that FDA will disagree with the decision and recommend a 510K. An example of a letter to file would be changing the needle diameter on an RF microneedling device to a smaller size, but not changing the overall output energy.

Regardless of how changes are documented, all the supporting tests must be complete and included in the change order or the letter to file, so even though an IEC test report is not submitted to FDA in a 510K, it is required for the letter to file.

PATIENT is Living being (person or animal) undergoing a medical, surgical or dental PROCEDURE [IEC 60601-1:2005, definition 3.76] (note: This matches with the ANSI/AAMI standard for the USA, and the EN standard for Europe).

Yes. IEC 60601-1 Clause 3.76 calls out a “Patient” as “Living being (person or animal) undergoing a medical, surgical or dental procedure”.

Yes, as that is a dental device being used on an Animal.

Any Mammals, Birds, Reptiles, Amphibians, Fish, etc.

The IEC 60601-1-2:2020 (Ed. 4.1) standard includes a new table, Table 11, which outlines the requirements for testing Radio Frequency Identification (RFID) immunity. Table 11 is required for all medical devices, both battery operated and AC mains (&while charging).

The AIM 7351731 standard includes testing at all the RFID frequencies and test levels specified in its Table 3, whereas IEC 60601-1-2:2020 Table 11 only looks at 3 frequencies.

This means that the frequencies tested under the IEC 60601-1-2:2020 Table 11 are a subset of those tested under the AIM 7351731 standard. The exact frequencies would depend on the specific device and its intended use.

The FDA CDRH stands for the Center for Devices and Radiological Health. It is a branch of the U.S. Food and Drug Administration (FDA) responsible for regulating medical devices and radiation emitting devices, and ensuring their safety and effectiveness. CDRH oversees a wide range of products, including surgical instruments, diagnostic devices, and radiological products like X-ray machines. The center also plays a key role in research and development, as well as post-market surveillance to monitor device performance after they are on the market.

While IEC standards provide technical and safety benchmarks, CDRH enforces compliance with FDA regulations and guidelines. These regulations may incorporate or align with IEC standards to harmonize international safety and performance requirements.

When someone is selling a product with a laser, US Federal Law (21CFR) requires them to file a “Product Report” to the CDRH and obtain an Accession Number.

If you are selling a product that employs a laser and you do not have an active CDRH with the FDA for your product then you are breaking US Federal Law.

It doesn’t matter if the laser diode itself has FDA approval, the end product itself has to have FDA approval.

You could be shut down, fined and all production put on hold if you are not in compliance.

The FDA’s rationale for testing medical devices in both AC and battery modes, even if the device can’t be used while charging, is primarily related to safety and effectiveness.

The FDA wants it done and to show the device will work properly after the tests are performed to the charger with EUT charging from it.

The main reason is because the charger could potentially cause damage to the unit, overcharge the battery in the unit, not charge the battery at all or charge at an improper voltage.

NOTE: There is only Pass/Fail criteria needed for the charger during the testing. No Essential Performance applies during the testing on the charger, if the EUT cannot turn on and operate during charging.

Yes, in December 2024.

This is not a CE Marking Directive/Regulation. This is going to require safety testing for products not in scope of the Radio Equipment Directive or Low Voltage Directive. Any devices with electronic function, even below 50 VAC or below 75 VDC, will require safety testing. Even products with no power are in scope.

The objective of this Regulation is to improve the functioning of the internal market while providing a high level of consumer protection. The EU is mandating a minimum safety level for all products.

The EU announced the New Legislative Framework (aka NLF) in 2008: https://single-market- economy.ec.europa.eu/single-market/goods/new-legislative-framework_en

This is an effort for the EU to force the various working groups responsible for Directives and Regulations to align on their requirements – for example: TF, EU DoC, the various modules, etc. For example… the The EU declaration of conformity should have the same format regardless of Directive.

They also aligned the definitions and responsibilities of actors in the supply chain – Manufacturers, importers, distributors, and Authorized EU Reps.

See the below for more information:

Here is the European Commission GPSR webpage: https://commission.europa.eu/business-economy- euro/doing-business-eu/eu-product-safety-and-labelling/product-safety/general-product-safety- regulation_en

Here is the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0988

See Article 9 – this law applies to things that would normally require no testing – like fishhooks, pocketknives, eye glass cases, guitar strings, etc.

REACH governs substances, mixtures, and articles. An article is defined by its physical characteristics rather than its chemical composition.

Examples:

• A screw is an article.
• A solenoid valve is a complex article made of multiple articles.
• An engine is a complex article composed of other complex articles and individual articles.

REACH applies to a list of regulated substances, including lead, Diboron trioxide, cadmium, and melamine (full list here).

Before January 5, 2021, companies had to report if they sent more than 1 ton per year of a Substance of Very High Concern (SVHC) at a concentration of 0.1% or higher (homogeneous level) to the EU.

However, the Waste Framework Directive (WFD) removed the 1-ton threshold, meaning that since January 5, 2021, any amount of an SVHC above 0.1% must be reported to the SCIP database, with no exemptions.

The importer (buyer) in the EU is responsible for the SCIP database submission, not the manufacturer.

If your company does not have an EU location, you cannot submit SCIP reports directly. Instead, you must provide the importer with:

1. An I6Z data file for submission, OR
2. A Bill of Materials (BoM), part counts, and supplier contact details to enable them to complete the report.

The WFD extends REACH by requiring detailed tracking of substances in products. It uses this data for regulatory reporting to ECHA (European Chemicals Agency), ensuring greater transparency in material composition for environmental and waste management purposes.

• Understanding the Waste Framework Directive (WFD)
• Understanding REACH