Expanded Scope of Accreditation for Medical Devices
As one of the first independent EMC laboratories to gain accreditation in the United States, Retlif supports conformity assessment schemes which rely on test data provided by ISO/IEC 17025 accredited laboratories. The US Food and Drug Administration (FDA) has recently embraced accreditation through a Pilot Program, the Accreditation Scheme for Conformity Assessment (ASCA).
ASCA incorporates international conformity assessment standards and practices with the goal of increasing confidence in medical device testing among FDA reviewers and medical device manufacturers. Anticipations are that this will decrease requests for additional information relating to testing methodologies when pre-market submissions include a declaration of conformity to an FDA-recognized consensus standard within the FDA ASCA Pilot Program.
Access For Retlif Customers:
Retlif medical equipment manufacturers can readily access this alternative path for FDA acceptance of EMC test reports. All three Retlif EMI facilities (Ronkonkoma NY, Goffstown NH, Harleysville PA) have achieved FDA ASCA Pilot Program accreditation.
Scopes Of Accreditation:
Scopes include basic EMC requirements contained within IEC 60601-1-2, Edition 4.0, 2014 and specific requirements for:
- Medical Electrical Equipment and Medical Electrical Systems used in the Home Health Care Environment
- Medical Electrical Equipment and Medical Electrical Systems used in the Emergency Medical Services Environment
- Endoscopic Equipment
- Infant Radiant Warmers
- Infant Transport Incubators
- Infant Incubators
- Ultrasonic Medical Diagnostic and Monitoring Equipment
- X-Ray Equipment for Computed Tomography
- Ambulatory Electrocardiographic Systems
- Medical Beds
- Nerve and Muscle Stimulators
- Dental Intra-Oral X-Ray Equipment
Contact ASCA@Retlif.com for more information.