- Home
- Accreditations
Accreditations
Sigma Scientific Services is an FDA ASCA accredited testing laboratory and is accredited by A2LA to ISO/IEC 17025:2017. Tests within our ASCA scope come with an ASCA summary test report for your FDA submission.
- FDA ASCA TL-114
- A2LA 4896.01
- ISO/IEC 17025:2017
Overview
Two accreditations, one laboratory
Our accreditations tell reviewers and notified bodies that our results are technically valid and that our test methods were assessed by an independent body.
- FDA ASCA, laboratory TL-114: accredited under the FDA Accreditation Scheme for Conformity Assessment since August 2022.
- A2LA certificate 4896.01: accredited to ISO/IEC 17025:2017 for medical electrical equipment and acoustic test methods.
- 11 standards in our ASCA scope: IEC 60601-1 and its collateral and particular standards for ultrasound, endoscopes, incubators, alarms, usability and home use.
- Clear reporting: every result is reported under the accreditation that covers it.
FDA ASCA scope · TL-114
Standards in our ASCA scope
As listed by the FDA for Sigma Scientific Services LLC, accredited by A2LA. Recognition numbers refer to the FDA recognized consensus standards database.
| Standard | Scope | Service |
|---|---|---|
| IEC 60601-2-37 | Ultrasonic medical diagnostic and monitoring equipment Recognition no. 12-293 · Ed. 2.1 (2015) · Granted Aug 17, 2022 | Service → |
| IEC 60601-2-5 | Ultrasonic physiotherapy equipment Recognition no. 12-205 · Ed. 3.0 (2009) · Granted Aug 17, 2022 | Service → |
| IEC 60601-2-62 | High intensity therapeutic ultrasound (HITU) equipment Recognition no. 12-281 · Ed. 1.0 (2013) · Granted Aug 17, 2022 | Service → |
| IEC 60601-1-11 | Home healthcare environment Recognition no. 19-38 · Ed. 2.1 (2020) · Granted Aug 17, 2022 | Service → |
| IEC 60601-1 | General requirements for basic safety and essential performance Recognition no. 19-49 · Ed. 3.2 (2020) · Granted Sep 9, 2024 | Service → |
| ANSI/AAMI ES60601-1 | US national version of IEC 60601-1 Recognition no. 19-46 · 2005/(R)2012 & A1:2012, A2:2021 · Granted Sep 9, 2024 | Service → |
| IEC 60601-1-6 | Usability Recognition no. 5-132 · Ed. 3.2 (2020) · Granted Sep 9, 2024 | Service → |
| IEC 60601-1-8 | Alarm systems Recognition no. 5-131 · Ed. 2.2 (2020) · Granted Sep 9, 2024 | Service → |
| IEC 60601-2-18 | Endoscopic equipment Recognition no. 9-114 · Ed. 3.0 (2009) · Granted Sep 9, 2024 | Service → |
| IEC 60601-2-19 | Infant incubators Recognition no. 6-461 · Ed. 3.0 (2020) · Granted Sep 9, 2024 | Service → |
| IEC 60601-2-20 | Infant transport incubators Recognition no. 6-462 · Ed. 3.0 (2020) · Granted Sep 9, 2024 | Service → |
Exclusion: clauses 10.1 to 10.7 of ANSI/AAMI ES60601-1 (radiation) are outside our ASCA scope. The FDA listing is the official reference: see TL-114 on the FDA website →
A2LA · ISO/IEC 17025:2017
Accredited test methods
Our A2LA scope covers the standards in our ASCA scope plus acoustic, imaging, optical and photobiological test methods.
| Standard | Scope | Accreditation |
|---|---|---|
| IEC 60601 series | The 11 standards in our ASCA scope, listed above | ASCA · A2LA |
| IEC 62127-1 | Hydrophones: measurement and characterization of medical ultrasonic fields | A2LA |
| IEC 62359 | Field characterization: test methods for the thermal and mechanical indices | A2LA |
| AIUM/NEMA UD 2 | Acoustic output measurement standard for diagnostic ultrasound equipment | A2LA |
| JIS T 1501 | Performance of pulse-echo ultrasound imaging equipment (image quality) | A2LA |
| IEC 61689 | Physiotherapy systems: field specifications and methods of measurement | A2LA |
| IEC 63045 | Non-focusing and ballistic pressure pulse sources: field characterization | A2LA |
| IEC 61846 | Pressure pulse lithotripters: characteristics of fields | A2LA |
| ISO 8600-1, -3, -4, -5 | Endoscopes: general requirements, field and direction of view, insertion width, optical resolution | A2LA |
| ISO 15739 | Electronic still-picture imaging: noise measurements | A2LA |
| ISO 12233 | Electronic still-picture imaging: resolution and spatial frequency response | A2LA |
| IEC 62471 | Photobiological safety of lamps and lamp systems (excludes 1100 to 3000 nm) | A2LA |
| ISO 15004-1, ISO 15004-2 | Ophthalmic instruments: general requirements and light hazard protection (excludes 1150 to 2500 nm) | A2LA |
Our A2LA certificate and full scope of accreditation: view the certificate and scope (PDF).
For your submission
What ASCA means for your 510(k)
ASCA lets the FDA rely on the test methods of an accredited laboratory, so reviewers can focus on your results.
FAQ
Frequently asked questions
How can I verify your ASCA accreditation?
The FDA publishes the list of ASCA accredited laboratories and their scope. Sigma Scientific Services LLC is listed as laboratory TL-114, accredited by A2LA. See the FDA listing.
What if my standard is not in your ASCA scope?
We can often still test to it: our A2LA ISO/IEC 17025 scope covers many methods beyond the ASCA program. Tell us the standard and we will tell you how it would be reported.
Can I get a copy of your certificates?
Yes. Request our A2LA certificate and scope of accreditation through the form below and we will send them to you.
Which edition of each standard do you test to?
The editions listed in our ASCA scope above. If you need a different edition, contact us and we will confirm how it can be tested and reported.
Request a quote or our certificates
Tell us about your device and the standards you need. You’ll have a quote within 24 hours.
(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325