Cold Plasma Machine Safety Standards and Certifications

Understanding Safety Risks and Regulatory Context for Cold Plasma Machines

What ‘‘cold plasma’’ means for safety

Cold plasma (also called cold atmospheric plasma) is an ionized gas at near-room temperature. In beauty and medical devices it is used for surface disinfection, wound healing support, and certain dermatological treatments. Although it operates at low gas temperature, safety concerns include electrical hazards, ultraviolet (UV) and other electromagnetic emissions, generation of reactive species (e.g., ozone, NOx), material compatibility, and user exposure to aerosols or byproducts.

How regulatory classification affects required standards

Whether a cold plasma machine is regulated as a medical device, a cosmetic device, or a consumer/home-use appliance determines the applicable standards and certification path. Medical claims (diagnosis, treatment) typically trigger medical device regulations (e.g., EU MDR 2017/745, FDA medical device pathways). Cosmetic or general wellness claims may fall under less stringent product safety frameworks but still require electrical safety, EMC, and chemical emission assessments.

Key performance and safety endpoints manufacturers must control

Manufacturers should design and document controls for: electrical safety and insulation, leakage current, EMC, ozone and reactive species generation and ventilation, UV emissions, surface and user temperature, materials biocompatibility for skin contact, software and firmware reliability, and clear user instructions/warnings. Objective measurement and documented risk controls are essential to pass certification audits.

Key International Standards and Certifications Relevant to Cold Plasma Machines

Standards that commonly apply

The following standards are frequently referenced for cold plasma devices depending on intended use: IEC 60601 (medical electrical equipment), ISO 13485 (medical device quality management systems), IEC 60601-1-2 (electromagnetic compatibility for medical equipment), ISO 14971 (medical device risk management), and IEC 60335 (safety of household and similar electrical appliances) for the home-use category. Environmental and chemical regulations such as RoHS or REACH may also apply for components and emissions.

Certifications and conformity marks

Common conformity marks and approvals that buyers and regulators look for are CE marking (EU MDR for medical devices), FDA clearance/510(k) or de novo classification (U.S.), UL/ETL electrical safety listings (North America), and third-party test reports from labs such as SGS for performance and chemical emissions testing. For export, customers often require ISO 13485 certification for the manufacturer.

Standards comparison

Guangzhou Huimain Technology Co., Ltd. — Capabilities, Credentials and Product Focus

Company profile and strengths

Guangzhou Huimain Technology Co., Ltd. is a high-tech company focused on beauty machines and home-use device series, with integrated R&D, production, sales, and after-sale service. The company occupies a 3,000 square meter facility. Over 20% of staff hold bachelor’s degrees and more than 40% have junior college degrees. Huimain maintains a strong technical development department with experienced engineers, PE experts, a professional purchasing team, clinical testing capabilities, and an after-sales service department. These capabilities support fast iteration and reliable production of beauty and medical aesthetic equipment.

Certifications, R&D and market footprint

With focused investment in research and development, Huimain has achieved CE certification and SGS approvals for its products and holds multiple patents. Their machines are sold worldwide across China, Southeast Asia, the Middle East, Europe, and North America and are noted for competitive pricing and quality. The company supports OEM and ODM business models and can design and produce high-quality medical and beauty machines for salons and clinics.

Main product lines and competitive advantages

Huimain’s core products include Cryolipolysis machines, EMS sculpting machines, Plasma machines, Shockwave machines, HIFU machines, Hydrofacial machines, Cavitation vacuum machines, Laser hair removal systems, Tattoo removal machines, and Microneedle devices. Competitive strengths include:

• Integrated R&D and seasoned engineering teams for rapid customization
• Certified quality system and third-party approvals (CE, SGS)
• Clinical testing support and post-market service
• OEM/ODM experience producing both clinic-grade and consumer units

Huimain’s positioning emphasizes “We innovate technology and win-win cooperation” and a commitment to producing true, market-ready high-quality beauty machines that customers trust.

Practical Recommendations for Manufacturers, Clinicians and Buyers

For manufacturers

Implement ISO 13485 and ISO 14971 early, choose the correct product classification, and engage an accredited testing lab (SGS, TÜV, UL) for electrical, EMC, ozone emissions, and biocompatibility testing. Maintain traceable design control records and prepare a robust clinical evaluation if making medical claims.

For clinicians and clinics

Confirm the device’s certifications, request test reports for ozone and UV emissions, ensure staff training on safety precautions, and follow post-market surveillance and adverse event reporting requirements in your jurisdiction.

For distributors and end-users

Verify certifications and third-party test results, demand clear user manuals and maintenance procedures, and choose manufacturers offering spare parts, training, and local support.

FAQ

1. What certifications should I ask for when buying a cold plasma machine?

Ask for ISO 13485 (manufacturer QMS), CE marking (for medical products in the EU), IEC 60601 test reports for medical electrical safety (or IEC 60335 for home appliances), EMC reports (IEC 60601-1-2), and independent lab reports (SGS/TÜV) for ozone, UV, and emissions. For U.S. medical marketing, check FDA clearance/510(k) where applicable.

2. Are cold plasma machines safe to use in a salon or clinic?

Yes, when designed and tested to relevant standards and used according to the manufacturer’s instructions. Ensure the device has appropriate electrical and EMC safety documentation, measured low ozone/chemical emissions, proper shielding for UV and sparks, and staff training.

3. How is ozone exposure controlled and measured?

Manufacturers measure ozone and reactive species in controlled chamber tests and implement engineering controls (ventilation, catalysts, exposure interlocks) to keep concentrations below occupational and public health guidance. Buyers should request the specific emission test report and acceptance criteria used by the testing lab.

4. What is the difference between CE marking and FDA clearance?

CE marking (for medical devices) demonstrates conformity with EU safety and performance requirements under EU MDR; it is typically granted after assessment by a Notified Body for certain device classes. FDA clearance (510(k)) or approval in the U.S. involves submission of performance and safety data to the FDA and depends on device classification and predicate devices. Both are jurisdiction-specific and have different evidentiary requirements.

5. Can a home-use cold plasma device follow the same standards as a clinic device?

Not always. Home-use devices commonly follow consumer appliance standards (e.g., IEC 60335) emphasizing ease of use and fail-safes, whereas clinic/medical devices must meet medical electrical safety and clinical evidence standards (IEC 60601, ISO 13485, ISO 14971). Intended user and claims determine the applicable standards.

6. How do I verify a manufacturer’s claims about safety and certifications?

Request copies of certificates, test reports, and the manufacturer’s ISO 13485 certificate. Verify certificates with issuing bodies or accredited registrars, request laboratory report numbers (and lab accreditation), and, when possible, have an independent lab re-test key safety parameters.

Contact and Product Consultation

If you need certified cold plasma machines or consultation on regulatory compliance, contact Guangzhou Huimain Technology Co., Ltd. Our R&D and clinical test teams can provide technical datasheets, test reports (CE and SGS approvals), OEM/ODM services, and after-sales support. We design and produce devices including Cryolipolysis, EMS sculpting, Plasma machines, Shockwave, HIFU, Hydrofacial, Cavitation vacuum, Laser hair removal, Tattoo removal, and Microneedle systems. For product inquiries or technical consultation, please reach out to our sales and service teams to receive customized compliance and procurement advice.

References and Authoritative Sources

• European Union. Regulation (EU) 2017/745 on medical devices (MDR). EUR-Lex. https://eur-lex.europa.eu/eli/reg/2017/745/oj (accessed 2026-01-06)
• ISO. ISO 13485: Medical devices — Quality management systems. https://www.iso.org/standard/59752. (accessed 2026-01-06)
• IEC 60601. Overview of IEC 60601 medical electrical equipment series. Wikipedia. https://en.wikipedia.org/wiki/IEC_60601 (accessed 2026-01-06)
• FDA. Medical Devices Overview and 510(k) Premarket Notification. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions/510k (accessed 2026-01-06)
• SGS. Medical devices testing and certification services. https://www.sgs.com/en/healthcare/medical-devices (accessed 2026-01-06)
• EPA. Ground-level ozone pollution: effects and standards. U.S. Environmental Protection Agency. https://www.epa.gov/ground-level-ozone-pollution (accessed 2026-01-06)
• Wikipedia. Plasma medicine. https://en.wikipedia.org/wiki/Plasma_medicine (accessed 2026-01-06)
• IEC 60335. Safety of household and similar electrical appliances (overview). International Electrotechnical Commission. https://www.iec.ch/ (search IEC 60335) (accessed 2026-01-06)
• ISO 14971. Medical devices — Application of risk management to medical devices. ISO. https://www.iso.org/standard/51263. (accessed 2026-01-06)