Formlabs Inc.は、本書に記載の製品が、現時点で、EU規則2017/745の第II条または連邦食品医薬品化粧品法（FD&C法）の第201条（h）で定義されている医療機器に分類されることを宣言します。このリストに含まれていないその他のFormlabs製品は、医療機器には分類されません。

Formlabsの電気機器は、ISO 9001 QMS認証を取得した施設で製造されています。Formlabsプリンタの製造基準に関する正式な声明については、こちらの文書をご参照ください。Formlabsは証明書を共有することはできません。

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.

Formlabsのプリンター、材料、および関連製品は、各管轄地域で適用されている様々な安全性や品質に関する規格に準拠し、様々な地域で製造されています。特定のFormlabs製品の製造国の情報については、御社内の営業担当者にお問い合わせください。