Formlabs Inc. erklärt hiermit, dass die in diesem Dokument aufgeführten Produkte derzeit als Medizinprodukte im Sinne von Artikel II der Verordnung (EU) 2017/745 oder von Abschnitt 201(h) des Federal Food Drug & Cosmetic (FD&C) Act eingestuft sind. Alle anderen Formlabs-Produkte, die nicht in dieser Liste aufgeführt sind, sind nicht als Medizinprodukte eingestuft.

Die elektrischen Geräte von Formlabs werden in Anlagen hergestellt, die nach ISO 9001 QMS zertifiziert sind. Eine formelle Erklärung zu den Fertigungsstandards für Formlabs-Drucker finden Sie in diesem Schreiben. Formlabs ist nicht in der Lage, die Zertifikate zu veröffentlichen.

Support articles:

• Safety with Formlabs SLA printers
• Safety with Formlabs SLS products

Formlabs hardware products are certified to the following relevant US, Canadian, and European safety standards:

Fuse X1

• UL 2011
• CSA C22.2 No. 301
• EN 60204-1
• IEC 60825-1
• IEC 62368-1
• FCC 47CFR Part 15 Subpart B: 12/2025
• AS/NZS CISPR 32:2015
• CENELEC EN 55032:2015+A11
• ETSI EN 301 489-1:2019 Ed.2.2.3
• ETSI EN 301 489-3:2023 Ed.2.3.2

Fuse 1 and Fuse 1+ 30W

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• ISO 11553-1:2020
• ISO 11252:2013
• ISO 11554:2017
• UL/CSA/IEC 62368-1:2014 Ed.2
• IEC 60825-1:2014
• Intertek Control Number: 5020213

Fuse Sift

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL/CSA/IEC 62368-1:2014 Ed.2
• IEC 60825-1:2014
• Intertek Control Number: 5020214

Fuse Blast

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• Outline of Investigation for Machinery [UL SUBJECT 2011:2022 Ed.7]
• Industrial Electrical Machinery (R2021) [CSA C22.2#301:2016 Ed.1]
• IEC 61010-1:2010, IEC 61010-1:2010/AMD1:2016
• Intertek Control Number: 5020214

Form 4/Form 4B

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 62368-1:2019 Ed.3+R:22Oct2021
• CSA C22.2#62368-1:2019 Ed.3+U1
• IEC 61000-3-2: 2018
• Intertek Control Number: 5029059

Form 4L/Form 4BL

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 62368-1:2019 Ed.3+R:22Oct2021
• CSA C22.2#62368-1:2019 Ed.3+U1
• Intertek Control Number: 5029059

Form 3/Form 3+ and Form 3B/Form 3B+

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• UL/CSA/ IEC 62368-1:2014
• UL E File #: E477754

Form Auto

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 62368-1:2019 Ed.3+R:22Oct2021
• CSA C22.2#62368-1:2019 Ed.3+U1
• IEC 62368-1:2018
• Intertek Control Number: 5025752

Form 3L and Form 3BL

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL/CSA/ IEC 62368-1:2014
• UL E File #: E477754

Form 2

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL E File #: E477754

Form Wash and Form Wash (2nd Generation)

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 62368-1:2019 Ed.3
• CSA C22.2#62368-1:2019 Ed.3
• IEC 62368-1:2018
• Intertek Control Number: 5009963

Form Cure

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 62368-1:2019 Ed.3
• CSA C22.2#62368-1:2019 Ed.3
• IEC 62368-1:2018
• Intertek Control Number: 5009963

Form Wash L

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL-61010-1:2012 Ed.3+R:19Jul2019
• CSA C22.2#61010-1-12:2012 Ed.3 +U1;U2;A1
• IEC 61010-1:2010/AMD1:2016
• Intertek Control Number: 5009963

Form Cure L

• European Machinery Directive 2006/42/EC
• Electromagnetic Compatibility 2014/30/EU
• Restriction of Hazardous Substances Directive 2011/65/EU
• EN ISO 12100:2010
• UL 61010-1:2012 Ed.3+R:19Jul2019
• UL 61010-2-010:2019 Ed.4
• CSA C22.2#61010-1-12:2012 Ed.3 +U1;U2;A1
• CSA C22.2#61010-2-010:2019 Ed.4
• IEC 61010-1:2010/AMD1:2016, IEC 61010-2-010:2019
• Intertek Control Number: 5009963

FDA Laser Accession

Formlabs has a laser accession number which is applicable to all our printers that have a laser: 2531030-000. This number is valid until August/September 2026.

Safe Unattended Use

This is to certify that Formlabs LFS and SLS 3D printers are safe for unattended / overnight use when operating according to the prescriptions from the latest versions of Formlabs operation manuals and with Formlabs manufactured resin.

• Formlabs LFS printers
• Formlabs SLS printers

Fire safety

Fire safety is evaluated as part of safety as a whole during hardware compliance testing. All Formlabs hardware products that have been certified through a Nationally Recognized Testing Laboratory (NRTL) have been evaluated for fire safety.

German Social Accident Insurance (DGUV)

Formlabs expects all printers to comply with DGUV requirements. If you are going to test a Fuse 1 generation printer for DGUV compliance, please contact Formlabs in advance to obtain full context on the best way to validate DGUV compliance.

Specifically, for RISO (insulation resistance) testing: The Fuse 1+ 30W contains Metal Oxide Varistors (MOVs) at the line inlet designed to shunt overvoltage to the ground. During a standard 500 VDC insulation test, these MOVs naturally conduct a small amount of current. This is a common occurrence in industrial electronics where surge protection is present, causing the tester to report a low resistance value despite the insulation being intact.

Formlabs verifies safety using dielectric strength testing per IEC 62368-1 and IEC 60204-1 during manufacturing. We recommend following the protocols within EN 50699 that account for electronic components. Specifically, the installer should perform a Protective Conductor Current measurement using the differential current method while the device is running. If the leakage current is within the limits specified by IEC 62368-1, the machine is safe for operation and the insulation resistance result can be documented as influenced by protective components. Alternatively, testing at a reduced voltage of 250 VDC may prevent the MOVs from conducting and allow for a passing resistance reading.

Die Drucker, Materialien und Produkte von Formlabs werden an verschiedenen Standorten hergestellt und erfüllen eine Vielzahl von Sicherheits- und Qualitätsnormen in unterschiedlichen Ländern. Bitte wenden Sie sich an Ihren Vertriebsmitarbeiter, um Informationen über das Herkunftsland eines bestimmten Produkts von Formlabs zu erhalten.