SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 INTERTEK JAPAN K.K. Yasuda Shibaura No.2 Bldg. 4F 3-2-12, Kaigan, Minato-ku Tokyo, Japan  108-0022 Ms. Masako Oyamada Phone: +81 465 89 2316 masako.oyamada@intertek.com ELECTRICAL Valid To: September 30, 2024 Certificate Number: 4046.01 In recognition of the successful completion of the A2LA evaluation process (including an assessment of the organization's compliance with A2LA's FDA ASCA Accreditation Program³ requirements), accreditation is granted to this laboratory to perform the following product safety tests: Test Technology: Product Safety MEAS, Measurement (excluding Ionizing Measurement, Laser Testing) MED, Medical (excluding Resistance to Environment Stress, Cathode Ray Tubes, Lasers and Light Emitting Diods, Primary Lithium Batteries, Protection against Hazards of Ignition of Flammable Anesthetics Mixtures, Simulated Use) Test Method(s) ¹,²: IEC 61010-1; ANSI UL 61010-1 3rd Ed dated May 12 2012 with revision through July 19 2019; IEC 61010-2-081; IEC 61010-2-101 ANSI AAMI ES60601-1:2005/®2012 and A1:2012, C1:2009/®2012 and A2:2010/®2012 (Consolidated Text); ANSI AAMI ES60601-1:2005/®2012 & A1:2012 C1:2009/®2012 & A2:2010/®2012 (Cons. Text) [Incl. AMD2:2021]; EN 60601; IEC 60601-1 ³; IEC 60601-1-1 ; IEC 60601-1-3 ³; IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION; IEC 60601-1-4 ; IEC 60601-1-6; IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION; IEC 60601-2-5; IEC 60601-2-18; IEC 60601-2-28 (Ed 2, Ed 3); IEC 60601-2-33; IEC 60601-2-33 Edition 4.0 2022-08: IEC 60601-2-37; IEC 60601-2-38; IEC 60601-2-41; IEC 60601-2-43 (Ed 2, Ed 2.1) (A2LA Cert. No. 4046.01) Revised 12/05/2023 Page 1 of 3 5202 Presidents Court, Suite 220 | Frederick, MD 21703-8515 | Phone: 301 644 3248 | Fax: 240 454 9449 | www.A2LA.org
On the following products or types of products: Medical Electrical Equipment, Laboratory Equipment, Information Technology Equipment. ¹When the date, revision or edition of a test method standard is not identified on the scope of accreditation, the laboratory is expected to be using the current version within one year of the date of publication, per part C., Section 1 of A2LA R101 - General Requirements - Accreditation of ISO-IEC 17025 Laboratories. ² The laboratory is only accredited for testing activities outlined within the test methods listed above. Reference to any other activity within these standards, such as risk management or risk assessment, does not fall within the laboratory's accredited capabilities.
3 These methods have been assessed by A2LA according to A2LA's FDA ASCA Program requirements. Accreditation by A2LA does not imply FDA ASCA-Accreditation. All ASCA-accreditation decisions for testing laboratory applications are made solely by the FDA, a list of approved laboratories can be found at FDA.gov. Accredited Laboratory A2LA has accredited INTERTEK JAPAN K.K. Tokyo, Japan for technical competence in the field of Electrical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This laboratory also meets A2LA R256 - Specific Requirements - FDA ASCA Program. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 9th day of December 2022. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 4046.01 Valid to September 30, 2024 For the tests to which this accreditation applies, please refer to the laboratory's Electrical Scope of Accreditation.