Effective September 19, 2023, the FDA is converting the Accreditation Scheme for Conformity 
Assessment program from a pilot to a permanent program. This transition is authorized by the 
Medical Device User Fee Amendments of 2022 (MDUFA V). This guidance was developed and 
issued prior to the enactment of MDUFA V. FDA is assessing how to revise this guidance to 
represent our current thinking on this topic, including the incorporation of best practices gained 
from the pilot phase of the Accreditation Scheme for Conformity Assessment program. For more 
information, please contact the ASCA Program at ASCA@fda.hhs.gov.   Contains Nonbinding Recommendations
Basic Safety and Essential 
Performance of Medical Electrical 
Equipment, Medical Electrical 
Systems, and Laboratory Medical 
Equipment  Standards Specific 
Information for the Accreditation 
Scheme for Conformity Assessment 
(ASCA) Pilot Program
Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and
Food and Drug Administration Staff
Document issued on September 25, 2020.
The draft of this document was issued on September 23, 2019.
For questions about this document regarding CDRH-regulated devices, contact the ASCA 
Pilot Program at ASCA@fda.hhs.gov. For questions about this document regarding CBER-
regulated devices, contact the Office of Communication, Outreach, and Development 
(OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research
OMB Control No. 0910-0889
Current expiration date available at https://www.reginfo.gov
See additional PRA statement in Section VI of this guidance. Contains Nonbinding Recommendations 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-3805. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 20011 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov, or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction .......................................................................................................................... 1 
II.  Scope .................................................................................................................................... 2 
III.  List of FDA-Recognized Consensus Standards in the ASCA Pilot for Basic Safety and 
Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and 
Laboratory Medical Equipment ...................................................................................................... 2 
IV.  Accreditation and Assessment of Testing Laboratories by ASCA- Recognized 
Accreditation Bodies ....................................................................................................................... 8 
A.  Scope of Assessments ...................................................................................................... 8 
B.  ASCA Program Specifications for Basic Safety and Essential Performance of Medical 
Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment .......... 8 
V.  Premarket Submission Contents for FDA-Recognized Consensus Standards in the ASCA 
Pilot for Basic Safety and Essential Performance ......................................................................... 15 
A.  Cover Letter .................................................................................................................... 15 
B.  Declaration of Conformity ............................................................................................. 15 
C.  Supplemental Documentation ........................................................................................ 15 
VI.  Paperwork Reduction Act of 1995 ..................................................................................... 16 
Appendix A: Example ASCA Declaration of Conformity (DOC) for Basic Safety and Essential 
Performance Standards in the ASCA Pilot ................................................................................... 18 
Appendix B: Example ASCA Summary Test Report for Basic Safety and Essential Performance 
Standards in the ASCA Pilot......................................................................................................... 21  Contains Nonbinding Recommendations 
Basic Safety and Essential 
Performance of Medical Electrical 
Equipment, Medical Electrical 
Systems, and Laboratory Medical 
Equipment  Standards Specific 
Information for the Accreditation 
Scheme for Conformity Assessment 
(ASCA) Pilot Program 
Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic. It does not establish any rights for any person and is not binding 
on FDA or the public. You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations. To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page. 
I.  Introduction 
This guidance provides information regarding how the basic safety and essential performance 
standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment 
Program (hereafter referred to as the ASCA Pilot). The ASCA Pilot is described in FDAs 
guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.1
                                                
1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-
conformity-assessment-asca-pilot-program 
1  Contains Nonbinding Recommendations 
For the edition of the FDA-recognized consensus standard(s) included in the ASCA Pilot, see 
the FDA Recognized Consensus Standards Database.2 For more information regarding use of 
consensus standards in regulatory submissions, please refer to FDAs guidance Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices3 and 
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in 
the Center for Biologics Evaluation and Research.4  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidance means that 
something is suggested or recommended, but not required.  
II.  Scope 
This guidance includes the following: 
  A list of the FDA-recognized consensus standards included in the ASCA Pilot for 
basic safety and essential performance; 
  The program specifications for the FDA-recognized consensus standards in the 
ASCA Pilot for basic safety and essential performance; and 
  The recommended premarket submission contents specific to FDA-recognized 
consensus standards for basic safety and essential performance when testing is 
conducted by an ASCA-accredited testing laboratory. 
FDA guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 
describes how accreditation bodies, testing laboratories, device manufacturers, and FDA staff 
participate in the ASCA Pilot as well as how FDA-recognized consensus standards and test 
methods are selected and how program specifications are developed. 
III.  List of FDARecognized Consensus Standards in the 
ASCA Pilot for Basic Safety and Essential Performance of 
Medical Electrical Equipment, Medical Electrical 
Systems, and Laboratory Medical Equipment
                                                
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
4 Available at Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the 
Center for Biologics Evaluation andhttps://www.fda.gov/regulatory-information/search-fda-guidance-
documents/standards-development-and-use-standards-regulatory-submissions-reviewed-center-biologics-
evaluation Research 
2 Contains Nonbinding Recommendations 
Evaluation of safety is critical for electrically powered medical devices. The IEC 
60601/806015 series of standards applies to devices used in patient care settings, while the 
IEC 61010-1 series applies to devices used in laboratory settings. These standards are used in 
the majority of premarket submissions for electrically powered medical devices to support 
device safety. These standards take an all-hazards approach to device safety, encompassing 
electrical, mechanical, and radiation hazards, among others, in addition to hazards posed by 
the environment of use. Besides addressing the wide range of generic safety requirements, 
the IEC 60601/80601 and IEC 61010 series include close to 100 particular standards with 
safety requirements for specific types of devices, such as clinical thermometers, infusion 
pumps, infant incubators, and laboratory centrifuges. 
The FDA-recognized consensus standards eligible for inclusion in the ASCA Pilot for basic 
safety and essential performance of medical devices and laboratory equipment are listed 
below. Any activities carried out by the testing laboratory under its scope of ASCA 
Accreditation to assess the conformity of a product to one or more of these standards is 
within the scope of the ASCA Pilot. The extent of FDA recognition (complete or partial) is 
provided in the Supplemental Information Sheet (SIS) for each standard listed in the FDA 
Recognized Consensus Standards Database.6 The SIS provides additional information to 
consider when using FDA-recognized consensus standards, such as relevant guidance 
documents that provide clarity on FDA recommendations for testing to support premarket 
submissions. 
  ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General 
requirements for basic safety and essential performance. 
  IEC 61010-1 Safety requirements for electrical equipment for measurement control 
and laboratory use - Part 1: General requirements. 
  IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for 
basic safety and essential performance - Collateral Standard: Electromagnetic 
disturbances - Requirements and tests. 
  IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirements for 
basic safety and essential performance - Collateral Standard: Radiation protection in 
diagnostic X-ray equipment. 
  IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for 
basic safety and essential performance - Collateral standard: Usability. 
  IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for 
basic safety and essential performance - Collateral Standard: General requirements 
tests and guidance for alarm systems in medical electrical equipment and medical 
electrical systems. 
                                                
5 In this document, the reference to the IEC 60601/80601 series of standards includes the ANSI/AAMI ES 
60601-1, the IEC and US adopted collaterals [6060-1-xx], the IEC 60601-2-xx, and the IEC or ISO 80601-2-xx 
particulars. 
6 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Contains Nonbinding Recommendations 
  IEC 60601-1-10 Medical electrical equipment - Part 1-10: General requirements for 
basic safety and essential performance - Collateral Standard: Requirements for the 
development of physiologic closed-loop controllers. 
  IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for 
basic safety and essential performance - Collateral Standard: Requirements for 
medical electrical equipment and medical electrical systems used in the home 
healthcare environment. 
  ANSI/AAMI HA60601-1-11 Medical Electrical Equipment - Part 1-11: General 
requirements for basic safety and essential performance - Collateral Standard: 
Requirements for medical electrical equipment and medical electrical equipment and 
medical electrical systems used in the home healthcare environment. 
  IEC 60601-1-12 Medical electrical equipment - Part 1-12: General requirements for 
basic safety and essential performance - Collateral Standard: Requirements for 
medical electrical equipment and medical electrical systems intended for use in the 
emergency medical services environment. 
  IEC 60601-2-1 Medical electrical equipment - Part 2-1: Particular requirements for 
the basic safety and essential performance of electron accelerators in the range 1 
MeV to 50 MeV. 
  IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for 
the basic safety and essential performance of high frequency surgical equipment and 
high frequency surgical accessories. 
  IEC 60601-2-5 Medical electrical equipment - Part 2-5: Particular requirements for 
the basic safety and essential performance of ultrasonic physiotherapy equipment. 
  IEC 60601-2-6 Medical electrical equipment - Part 2-6: Particular requirements for 
the basic safety and essential performance of microwave therapy equipment. 
  IEC 60601-2-8 Medical electrical equipment - Part 2-8: Particular requirements for 
the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV. 
  IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements 
for the basic safety and essential performance of nerve and muscle stimulators. 
  IEC 60601-2-11 Medical electrical equipment - Part 2-11: Particular requirements 
for the basic safety and essential performance of gamma beam therapy equipment. 
  IEC 60601-2-16 Medical electrical equipment - Part 2-16: Particular requirements 
for the basic safety and essential performance of haemodialysis haemodiafiltration 
and haemonfiltration equipment. 
  IEC 60601-2-17 Medical electrical equipment - Part 2-17: Particular requirements 
for the safety of automatically-controlled brachytherapy after loading equipment. 
  IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements 
for the basic safety and essential performance of endoscopic equipment. 
4 Contains Nonbinding Recommendations 
  IEC 60601-2-19 Medical electrical equipment - Part 2-19: Particular requirements 
for the basic safety and essential performance of infant incubators. 
  IEC 60601-2-20 Medical electrical equipment - Part 2-20: Particular requirements 
for the basic safety and essential performance of infant transport incubators. 
  IEC 60601-2-21 Medical electrical equipment - Part 2-21: Particular requirements 
for the basic safety and essential performance of infant radiant warmers. 
  IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements 
for basic safety and essential performance of surgical cosmetic therapeutic and 
diagnostic laser equipment. 
  IEC 60601-2-23 Medical electrical equipment - Part 2-23: Particular requirements 
for the basic safety and essential performance of transcutaneous partial pressure 
monitoring equipment. 
  IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements 
for the basic safety and essential performance of electrocardiographs. 
  IEC 60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements 
for the basic safety and essential performance of electrocardiographic monitoring 
equipment. 
  IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements 
for the basic safety and essential performance of X-ray tube assemblies for medical 
diagnosis. 
  IEC 60601-2-29 Medical electrical equipment - Part 2-29: Particular requirements 
for the basic safety and essential performance of radiotherapy simulators. 
  IEC 60601-2-31 Medical electrical equipment Part 2-31: Particular requirements for 
the basic safety and essential performance of external cardiac pacemakers with 
internal power source. 
  IEC 60601-2-33 Medical electrical equipment - Part 2-33: Particular requirements 
for the basic safety and essential performance of magnetic resonance equipment for 
medical diagnosis. 
  IEC 60601-2-34 Medical electrical equipment - Part 2-34: Particular requirements 
for the basic safety including essential performance of invasive blood pressure 
monitoring equipment. 
  IEC 60601-2-36 Medical electrical equipment - Part 2-36: Particular requirements 
for the safety of equipment for extracorporeally induced lithotripsy. 
  IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements 
for the basic safety and essential performance of ultrasonic medical diagnostic and 
monitoring equipment. 
  IEC 60601-2-43 Medical electrical equipment - Part 2-43: Particular requirements 
for the safety and essential performance of X-ray equipment for interventional 
procedures. 
5 Contains Nonbinding Recommendations 
  IEC 60601-2-44 Medical electrical equipment - Part 2-44: Particular requirements 
for the basic safety and essential performance of x-ray equipment for computed 
tomography. 
  IEC 60601-2-45 Medical electrical equipment - Part 2-45: Particular requirements 
for the basic safety and essential performance of mammographic X-ray equipment 
and mammographic stereotactic devices. 
  IEC 60601-2-47 Medical electrical equipment - Part 2-47: Particular requirements 
for the basic safety and essential performance of ambulatory electrocardiographic 
systems. 
  IEC 60601-2-50 Medical electrical equipment - Part 2-50: Particular requirements 
for the basic safety and essential performance of infant phototherapy equipment. 
  IEC 60601-2-52 Medical electrical equipment - Part 2-52: Particular requirements 
for basic safety and essential performance of medical beds. 
  IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements 
for the basic safety and essential performance of X-ray equipment for radiography 
and radioscopy. 
  IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular requirements 
for the basic safety and essential performance of non-laser light source equipment 
intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use. 
  IEC 60601-2-62 Medical electrical equipment - Part 2-62: Particular requirements 
for the basic safety and essential performance of high intensity therapeutic 
ultrasound (HITU) equipment. 
  IEC 60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements 
for the basic safety and essential performance of dental extra-oral X-ray equipment. 
  IEC 60601-2-64 Medical electrical equipment - Part 2-64: Particular requirements 
for the basic safety and essential performance of light ion beam medical electrical 
equipment. 
  IEC 60601-2-65 Medical electrical equipment - Part 2-65: Particular requirements 
for the basic safety and essential performance of dental intra-oral-X-ray equipment. 
  IEC 60601-2-68 Medical electrical equipment - Part 2-68: Particular requirements 
for the basic safety and essential performance of X-ray-based image-guided 
radiotherapy equipment for use with electron accelerators light ion beam therapy 
equipment and radionuclide beam therapy equipment. 
  IEC/TR IEC 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and 
interpretation - Electromagnetic immunity: performance of medical electrical 
equipment and medical electrical systems. 
  ISO 80601-2-12 Medical electrical equipment - Part 2-12: Particular requirements 
for the safety of lung ventilators - Critical care ventilators. 
6 Contains Nonbinding Recommendations 
  ISO 80601-2-13 Medical electrical equipment - Part 2-13: Particular requirements 
for basic safety and essential performance of an anaesthetic workstation. 
  IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular requirements 
for the basic safety and essential performance of automated non-invasive 
sphygmomanometers. 
  IEC 80601-2-35 Medical electrical equipment-Part 2-35: Particular requirements for 
the basic safety and essential performance of heating devices using blankets pads or 
mattresses and intended for heating in medical use. 
  ISO 80601-2-55 Medical electrical equipment - Part 2-55: Particular requirements 
for the basic safety and essential performance of respiratory gas monitors. 
  ISO 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements 
for basic safety and essential performance of clinical thermometers for body 
temperature measurement. 
  IEC 80601-2-59 Medical electrical equipment - Part 2-59: Particular requirements 
for the basic safety and essential performance of screening thermographs for human 
febrile temperature screening. 
  IEC 80601-2-60 Medical electrical equipment - Part 2-60: Particular requirements 
for the basic safety and essential performance of dental equipment. 
  ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements 
for basic safety and essential performance of pulse oximeter equipment. 
  ISO 80601-2-69 Medical electrical equipment - Part 2-69: Particular requirements 
for basic safety and essential performance of oxygen concentrator equipment. 
  ISO 80601-2-70 Medical Electrical Equipment - Part 2-70: Particular Requirements 
for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy 
Equipment. 
  ISO 80601-2-72 Medical electrical equipment - Part 2-72: Particular requirements 
for basic safely and essential performance of home healthcare environment 
ventilators for ventilator-dependent patients. 
  ISO 80601-2-74 Medical electrical equipment - Part 2-74: Particular requirements 
for basic safety and essential performance of respiratory humidifying equipment. 
  IEC 80601-2-77 Medical electrical equipment - Part 2-77: Particular requirements 
for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED 
SURGICAL EQUIPMENT. 
  ISO 80601-2-79 Medical electrical equipment - Part 2-79: Particular requirements 
for basic safety and essential performance of ventilatory support equipment for 
ventilatory impairment. 
  ISO 80601-2-80 Medical electrical equipment - Part 2-80: Particular requirements 
for basic safety and essential performance of ventilatory support equipment for 
ventilatory insufficiency. 
7 Contains Nonbinding Recommendations 
IV.  Accreditation and Assessment of Testing Laboratories 
by ASCA Recognized Accreditation Bodies
A.  Scope of Assessments 
Section 7 of ISO/IEC 17011: Conformity assessment  Requirements for accreditation bodies 
accrediting conformity assessment bodies (hereafter referred to as ISO/IEC 17011) 
describes processes by which accreditation bodies assess testing laboratories. In order to 
maintain conformance to ISO/IEC 17011, an accreditation body assesses a sample of the 
scope of accreditation of its accredited testing laboratories at least every two years.7 There 
are no additional expectations for assessments under the ASCA Pilot for basic safety and 
essential performance standards. That is, in the ASCA Pilot, ASCA-recognized accreditation 
bodies may assess a sample of the basic safety and essential performance standards in order 
to ensure competence across the testing laboratorys entire scope of ASCA Accreditation. 
B.  ASCA Program Specifications for Basic Safety and 
Essential Performance of Medical Electrical Equipment, 
Medical Electrical Systems, and Laboratory Medical 
Equipment 
The ASCA program specifications in this section provide expectations for the accreditation 
of testing laboratories for basic safety and essential performance of medical electrical 
equipment, medical electrical systems, and laboratory medical equipment under the ASCA 
Pilot.  ASCA-recognized accreditation bodies, following the processes of ISO/IEC 17011, 
accredit testing laboratories to ISO/IEC 17025:2017: General requirements for the 
competence of testing and calibration laboratories (hereafter referred to as ISO/IEC 
17025) as well as the ASCA program specifications identified in this section. In addition, all 
testing should be conducted considering the recommendations of relevant FDA guidance 
documents (Refer to Section III. of this guidance). For readability and ease of reference, the 
numbering and nomenclature (including the term requirements)8 below correspond to the 
numbering and nomenclature of clauses/subclauses in ISO/IEC 17025.  
ISO/IEC 17025 Section 4 General requirements 
For the purposes of the ASCA Pilot, testing laboratories inspect the manufacturers risk 
management file to the extent necessary to assess compliance with the expectations of IEC 
60601/80601 or IEC 61010. The testing laboratories do not make judgments concerning the 
adequacy of the manufacturers risk management process. Nor do they make judgments 
concerning the acceptability of risk or the adequacy of the manufacturers decisions 
concerning risk. Each time a clause of IEC 60601/80601 or IEC 61010 calls for inspection of 
the risk management policy, plan, or records (i.e., the risk management file), it is to check to 
see if a related IEC 60601/80601 or IEC 61010 expectation has been complied with. 
                                                
7 See 7.9.3 of ISO/IEC 17011: 2017: Conformity assessment  Requirements for accreditation bodies 
accrediting conformity assessment bodies. 
8 Some definitions within voluntary consensus standards refer to requirements.  FDAs references to them for 
the ASCA Pilot do not make them legal or regulatory requirements unless specifically identified as such.  
8 Contains Nonbinding Recommendations 
4.1 Impartiality 
If any services, such as consulting, design, or research, are offered by the testing laboratory, 
it will have a policy and procedure for maintaining impartiality through separation of those 
services from its testing activities. 
A device manufacturers internal testing laboratory agrees to have policy and procedures that 
specifically ensure and protect the impartiality of the laboratory to test or otherwise evaluate 
devices manufactured by the laboratorys parent organization and, if applicable, other 
manufacturers without regard to the impact of the test results on the parent organizations 
business interests. 
4.2 Confidentiality 
There are no additional specifications above those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 5 Structural requirements 
There are no additional specifications above those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 6 Resource requirements 
6.1 General 
There are no additional specifications above those set forth in ISO/IEC 17025. 
6.2 Personnel 
a)  The testing laboratory agrees to maintain technical personnel who are qualified and 
competent to: 
  Establish and carry out the appropriate test methods required for the standard. 
  Understand and apply the specifications and underlying rationale (including 
concepts of basic safety and essential performance). 
  Understand other normative references in the relevant standards forming part of 
the requested scope of accreditation. 
  Assure the suitability of means used to confirm the basic safety and essential 
performance of the medical device under test. 
b)  The testing laboratory agrees to: 
  Document and maintain a program for the initial and ongoing training of technical 
personnel, including procedures for applying new/updated test methods and 
performing required tests. 
  Provide ongoing training of technical personnel at defined intervals or when test 
standards or methods are updated or developed, as well as when responsibilities 
have changed. 
  Conduct training through appropriate training mechanisms, such as on-the-job 
training or formal classroom training. 
  Document and maintain records of training for technical personnel. 
9 Contains Nonbinding Recommendations 
c)  The job descriptions specify and document the responsibilities and required 
competencies of managerial, technical, and key support personnel involved in 
requested scope of accreditation. 
6.3 Facilities and environmental conditions 
There are no additional specifications to those set forth in ISO/IEC 17025. 
6.4 Equipment 
a)  The testing laboratory agrees to ensure that all equipment used for testing and 
evaluating devices is available and in proper working order for requested scope of 
accreditation. 
b)  The testing laboratory agrees to ensure that its procedures specify the steps for 
establishing calibration intervals for each type or item of equipment, and specify 
criteria, steps, and approvals for extending the calibration interval of an instrument. 
c)  The testing laboratory agrees to ensure that its procedures address adding, deleting, 
modifying, or maintaining information in equipment records in an accurate and timely 
manner, and specify the personnel responsible for these tasks. 
d)  The testing laboratory agrees to have procedures to examine the effects of defective 
or out-of-tolerance equipment on calibrations and tests. The testing laboratory further 
agrees that procedures will identify the personnel responsible for such examinations, 
specify their responsibilities, and provide the steps for the examination, including: 
  Determining whether the effects are unacceptable (including the accept/reject 
criteria) 
  Identifying the devices affected 
  Analyzing the particular tests impacted for these devices; and determining 
whether retesting is required 
  Preparing a report of the examination 
  Notifying customers when retesting is required; and 
  Specifying the steps to follow to perform the retesting 
6.5 Metrological traceability 
There are no additional specifications to those set forth in ISO/IEC 17025. 
6.6 Externally provided products and services 
There are no additional specifications to those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 7 Process requirements 
7.1 Review of requests, tenders and contracts 
a)  The testing laboratory agrees to have contracts with customers that require the 
customer to: 
  Identify those tests and test results that are intended to be used to support 
premarket submissions to the FDA; 
10 Contains Nonbinding Recommendations 
  Identify special test conditions and additions or modifications to test methods 
and/or acceptance criteria as permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5 
and ISO/IEC 17025 subclause 7.2.1.4; and 
  Indicate that per the risk management requirements of IEC 60601/80601 and IEC 
61010 the customer maintains responsibility for specifying and documenting 
acceptance criteria. 
7.2 Selection, verification and validation of methods 
a)  The testing laboratory agrees that its management system will include procedures 
governing the development, maintenance, and use of test procedures (including 
associated records in paper or electronic format such as test data forms and 
checklists). The testing laboratory further agrees that these management system 
procedures will include steps for: 
  Ensuring that test procedures are documented and reviewed prior to use; 
  Identifying the personnel responsible for developing, reviewing, and maintaining 
test procedures; 
  Ensuring that new and revised test procedures are reviewed by personnel who are 
competent and trained in the applicable standard(s); and 
  Specifying the criteria for review. 
b)  The testing laboratory agrees that test procedures and project-specific test plans will 
include or specify, as appropriate, the following information: 
  Unique identification, including title, document number, revision, and effective 
date; 
  Specific test equipment to use or the salient performance characteristics required 
of the equipment to be used; 
  Warnings/caution statements to alert the operators of potential hazards; 
  Normal and any unusual ambient conditions (including tolerances) for tests; 
  Test data to be obtained and recorded; 
  Objective acceptance criteria for results including the essential performance 
required to be maintained; 
  Testing techniques required to ensure consistent results; 
  Instructions on equipment operation and on handling and preparation of test 
samples (including instructions on multiple sample marking, if applicable); and 
  The methods to be used to assess or monitor the performance of the test sample. 
c)  The testing laboratory agrees to ensure that relevant contextual information from the 
intended use of the device and manufacturers essential performance specifications, 
including any metrological stability, are reflected in the relevant test procedure or 
project-specific test plan. 
d)  The testing laboratory agrees to ensure that each test procedure adequately addresses 
all the applicable specifications of the standard for the equipment under test. 
11 Contains Nonbinding Recommendations 
e)  The testing laboratory agrees to give preference to using test methods in the requested 
scope of accreditation. Modified test methods as permitted by IEC 60601-1 
subclauses 4.2.3.2 and 4.5 and ISO/IEC 17025 subclause 7.2.1.4 may be used within 
the ASCA Pilot as long as details of the test method and results are provided.  
Note: Recommendations for how to report the modified test method can be found in 
FDAs guidance Recommended Content and Format of Non-Clinical Bench 
Performance Testing Information in Premarket Submissions.9
f)  The testing laboratory agrees to include relevant sections of the test report in the 
ASCA summary test report as necessary to explain any testing to address risks that 
are different or in addition to those found in the FDA-recognized consensus standard. 
g)  Where a clause of the FDA-recognized consensus standard requires inspection of the 
risk management file to obtain objective evidence, the testing laboratory agrees, at a 
minimum, to include pass/fail criteria in the inspection procedure and record the list 
of documents examined during the inspection in the testing laboratorys records. 
7.3 Sampling 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.4 Handling of test or calibration items 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.5 Technical records 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.6 Evaluation of measurement uncertainty 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.7 Ensuring the validity of results 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.8 Reporting of results 
a)  The testing laboratory agrees to have procedures to record and report all required 
information in ISO/IEC 17025 for each test conducted, including the following: 
  A statement of the extent to which the articles that were tested complied or did 
not comply with the specifications of each clause that were part of the standard 
tested; 
  A detailed description of the medical device tested including accessories, options, 
software versions, and configurations tested; 
  A test plan including reference to the manufacturers stated intended use and 
essential performance claims monitored during testing, reporting of the 
operational state(s) of the equipment during each test, as well as, if needed, any 
                                                
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-
content-and-format-non-clinical-bench-performance-testing-information-premarket 
12 Contains Nonbinding Recommendations 
modified test methods as permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5 
and ISO/IEC 17025 subclause 7.2.1.4. 
Note: Recommendations for how to report the modified test methods can be found 
in the guidance document Recommended Content and Format of Non-Clinical 
Bench Performance Testing Information in Premarket Submissions. 
  The date and location of the test(s) undertaken; 
  The test reports unique identifier; 
  The signatures and printed names of the personnel responsible for the test results; 
  The test conditions, e.g., supply voltage, ambient temperature or humidity, when 
relevant to the test; 
  All of the applicable data required for equipment under test according to the 
standard; 
  A statement of the estimated uncertainty of measurement, when it is relevant to 
the validity or application of the test results, when a customers instructions so 
requires or when the uncertainty affects compliance to a specification limit; and  
  A statement that test report meets ASCA program specifications. 
b)  The testing laboratory agrees not to report test results in a simplified way as 
mentioned in subclause 7.8.1.3. Instead, the applicant agrees to report to the customer 
all information listed in subclauses 7.8.2 through 7.8.7 to the extent applicable. 
(subclause 7.8.4 is for calibration certificates and is not applicable when testing to the 
requirements of IEC 60601.) 
c)  The testing laboratory agrees to convey in writing to the customer all opinions and 
interpretations, including concerns about basic safety and essential performance such 
as: 
  Anomalous test results noted during any part of the testing that were not resolved 
to the testing laboratorys satisfaction. 
  Concerns regarding any other aspect of conformity to the standard. 
d)  The testing laboratory agrees to require that testing conducted by subcontractors will 
also comply with the above test report specifications, as applicable.  
e)  The testing laboratory agrees that an ASCA Summary Test Report as specified in this 
guidance will be submitted to the client at the end of testing activities.  
f)  The testing laboratory agrees to convey in writing to the customer all observations 
recorded during execution of a project test plan. 
Note. An observation is a device behavior that is not directly related to the pass/fail 
assessment being made at that time. An observation is recorded to make the customer 
aware of a device behavior which, while it might be out-of-scope for the test plan 
being executed, could indicate a potential quality issue. It is the customers 
responsibility to assess this further. 
13 Contains Nonbinding Recommendations 
7.9 Complaints 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.10 Nonconforming work 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.11 Control of data and information management 
There are no additional specifications to those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 8 Management system requirements 
8.1 Options 
Regardless of the option selected (i.e., ISO/IEC 17025 Option A or Option B), the testing 
laboratory agrees to maintain an index of standard operating procedures (SOPs) and any 
relevant ASCA test-related documents (e.g., SOPs, test methods, work instructions, master 
protocols, test-specific protocols, data collection worksheets, training information) applicable 
to any of the standards included in the ASCA Pilot for basic safety and essential performance 
of medical devices and laboratory equipment program specifications in this Appendix. 
14 Contains Nonbinding Recommendations 
V.  Premarket Submission Contents for FDARecognized 
Consensus Standards in the ASCA Pilot for Basic Safety 
and Essential Performance
FDA recommends that the following be included in any regulatory submission that contains 
basic safety and essential performance testing conducted by an ASCA-accredited testing 
laboratory. 
A.  Cover Letter 
FDA recommendations for a cover letter for a premarket submission containing testing 
results from an ASCA-accredited testing laboratory are provided in FDAs guidance The 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. 
B.  Declaration of Conformity 
Section IV.A. of FDAs guidance Appropriate Use of Voluntary Consensus Standards in 
Premarket Submissions for Medical Devices10 recommends contents for a DOC to an FDA-
recognized consensus standard. For basic safety and essential performance testing from an 
ASCA-accredited testing laboratory, FDA recommends the device manufacturer include the 
following additional items in a DOC: 
  Date(s) the testing was conducted 
  Location(s) where the testing was conducted 
  Confirmation that the FDA-recognized consensus standards used during testing were 
within the laboratorys scope of ASCA Accreditation and not subject to any temporary 
labeling constraints as a result of a suspension of ASCA Accreditation at the time 
testing was conducted. If the relevant standard was impacted by a suspension of 
ASCA Accreditation, the DOC should include an explanation of how this suspension 
may or may not affect the testing results.  
  Limitations on the validity of the DOC: 
  How the test article compares with the device provided in this premarket 
submission (including any modifications made during testing) 
  How any concerns communicated by the test laboratory were resolved 
  How any observations and/or degradations during testing were resolved 
An example DOC is provided in Appendix A of this guidance. This example provides one 
approach to how a single DOC might contain testing to FDA-recognized consensus standards 
included and not included in a testing laboratorys scope of ASCA Accreditation. 
C.  Supplemental Documentation 
                                                
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
15 Contains Nonbinding Recommendations
An ASCA summary test report is recommended for all testing conducted under the ASCA 
Pilot.11 An example ASCA summary test report is provided in Appendix B of this guidance. 
Note that the ASCA-accredited testing laboratory provides the ASCA summary test report to 
the device manufacturer who then includes it with its own DOC in a premarket submission to 
FDA.
During the ASCA Pilot, FDA generally will accept determinations from ASCA-accredited 
testing laboratories (i.e., test results) when the standard and test methods are within the 
testing laboratorys scope of ASCA Accreditation at the time of testing. Circumstances where 
FDA may request and review additional information relating to testing from an ASCA-
accredited testing laboratory are described in the bulleted points of Section XIII.A of the 
guidance titled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot 
Program. 
The ASCA Pilot processes and policies enhance confidence in testing results only when 
specific test methods and acceptance criteria are used. In cases where the standard permits  
modifications or additions to individual clauses to ensure basic safety and essential 
performance, FDA recommends that the premarket submission include the test plan and 
procedure, acceptance criteria, and results justifying the safety claim. In such cases, FDA 
recommends that the ASCA summary test report include relevant information about the 
testing that was performed. The following examples illustrate a few situations where this 
additional documentation is appropriate. 
 Where a test method specified in a clause of the standard was modified based on 
specific characteristics and/or intended use of the device or its operating conditions.
 Where the acceptance criteria specified in a clause was modified based on the 
manufacturers risk management.
 Where clauses in the IEC 60601/80601 and IEC 61010 series do not provide specific 
test methods and acceptance criteria. For example, a clause might indicate 
compliance is checked by inspection of the risk management file and functional tests 
if necessary. In other cases, a clause may provide for revision of the specific test 
methods and acceptance criteria based on risk management. 
VI.  Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521). 
11An ASCA summary test report is different from the test report summary described in FDAs guidance 
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket 
Submissionsavailable at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket
16 Contains Nonbinding Recommendations
The time required to complete this information collection is estimated12 to average 95 hours 
per response for accreditation bodies and 47 hours for testing laboratories. Send comments 
regarding this burden estimate or suggestions for reducing this burden to: 
FDA PRA Staff, 
Office of Operations, 
Food and Drug Administration, 
PRAStaff@fda.hhs.gov
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number. 
The OMB control number for this information collection is 0910-0889 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov).
12Rounded to the nearest whole number.
17 Contains Nonbinding Recommendations 
Appendix A: Example ASCA Declaration of Conformity 
(DOC) for Basic Safety and Essential Performance 
Standards in the ASCA Pilot 
Note: This example is intended to illustrate elements of the Declaration of Conformity per 
FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices that the device manufacturer submits as part of their 
premarket submission. 
Responsible Party 
Name of entity responsible for DOC: ____________________________________________ 
Address of entity responsible for DOC: ___________________________________________ 
Product/Device Identification 
All identifying information for the product/device including (e.g., product code(s), device 
marketing name(s), model number(s), etc.). 
Statement of Conformity 
 The test results demonstrate that the device is in conformity with the standard(s) listed 
below13: 
  Title of Standard: (e.g., ANSI/AAMI ES60601-1 Medical electrical equipment - 
Part 1: General requirements for basic safety and essential performance.)______ 
  FDA Recognition #: (e.g., 19-4) 
  Options Selected 
   Standard included no options 
   Standard included options
List of options selected in standard (e.g., clause 5.3 permits modified test 
conditions if ambient temperature cannot be maintained). No information is 
needed in this section if testing is from an ASCA-accredited test lab; instead, 
this section may reference the ASCA summary test report provided as 
supplementary documentation. 
  Testing Laboratory Name: (e.g., Testing Laboratory ABC)___________________ 
  ASCA Testing Laboratory Identification Number (as applicable): (e.g., ASCA001) 
  Testing Location(s): (e.g., 1234 Example Road, Silver Spring, MD 20993)______ 
  Testing Date(s): (e.g., Sep 1, 2020  Sep 15, 2020)_________________________ 
  ASCA Accreditation Status on the Date(s) of Testing: 
   Standard was not in testing laboratorys scope of ASCA Accreditation 
   Standard was in testing laboratorys scope of ASCA Accreditation; 
                                                
13 See section 514(c)(3)(A)(i) of the FD&C Act, cited in Section IV.A.(3)(f) of FDAs guidance Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Device. 
18 Contains Nonbinding Recommendations 
   ASCA Accreditation was not suspended
   ASCA Accreditation was suspended
Description of reasons for suspension and their impact on testing results, 
including date(s) of suspension. 
  Supplemental Documentation (Refer to Section V.C. of this guidance for specific 
recommendations): 
   Supplementary documentation is not included 
   Supplementary documentation is included at the following location within the 
submission, and I have checked that there are no differences regarding 
protocol and data between the testing conducted and the supplemental 
documentation: (e.g., Appendix A of this premarket submission)__________
<Repeat for each standard in DOC> 
Limitations on Validity of DOC 
Description of any limitation on the validity of the DOC (e.g., how long the declaration is 
valid, what was tested, or concessions made about the testing outcomes). For testing from an 
ASCA-accredited test lab, this should include: 
  Information on how the test article compares with the device provided in this 
premarket submission (including, any modifications made during testing for basic 
safety and essential performance can be found at the following location in this 
premarket submission: (e.g., Section V, pages 45-50)_______________________ 
  Information on how any concerns communicated by the test laboratory were 
resolved can be found at the following location in this premarket submission: (e.g., 
Appendix D of this premarket submission) 
  Information on how any observations and/or degradations during testing were 
resolved can be found at the following location in this premarket submission: (e.g., 
Appendix D of this premarket submission) 
  Information about how conformity was assessed for clauses of the relevant 
standard(s) that were not evaluated by an ASCA-accredited testing laboratory, 
including detailed information about who performed such testing, the test methods 
used, and the test results: (e.g., identification, marking and documents (clauses 7.1-
7.9) were evaluated by the manufacturer and are described in section X. of this 
premarket submission; all aspects of these clauses have been adequately addressed 
to support conformance to the standard) 
  Information on how the labeling requirements of the standard are met can be found 
at the following location(s) in this premarket submission: (e.g., Section X. of this 
premarket submission)______________________________________________ 
19 Contains Nonbinding Recommendations 
Signature 
Printed name: _______________________________________________________________ 
Function within entity responsible for DOC: _______________________________________ 
___________________________________________________________________________
Signature                                Date 
20 Contains Nonbinding Recommendations 
Appendix B: Example ASCA Summary Test Report for 
Basic Safety and Essential Performance Standards in the 
ASCA Pilot 
Note: This example is intended to illustrate the supplemental documentation that should 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number: 
3.  Testing Location(s): 
4.  Testing Date(s): 
5.  ASCA Accreditation Status on the Date(s) of Testing: 
   Standard was *NOT* in testing laboratorys scope of ASCA Accreditation14
   Standard was in testing laboratorys scope of ASCA Accreditation
   ASCA Accreditation was not suspended
   ASCA Accreditation was suspended
Description of reasons for suspension and their impact on testing results. 
Device Essential Performance Characteristics 
Description of the device essential performance characteristics supplied by the device 
manufacturer to the testing laboratory (including reference to any relevant particular 
standards with essential performance specified) and which were included in the testing. List 
any differences (if any identified) between the essential performance identified by the 
standard and the essential performance considered during the test. For multiple standards 
and/or multiple tests, include the essential performance characteristics used for each. 
Use Environment 
   Home Healthcare Environment [IEC 60601-1-11]
   Professional Healthcare Facility Environment
   Magnetic Resonance (MR) Environment 
   Aircraft Environment
  Emergency Medical Services Environment [IEC 60601-1-12]
   Special / Other Environment
                                                
14 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
21 Contains Nonbinding Recommendations 
Include any relevant details regarding the specified use environment here. 
Clauses Tested 
1.  Clauses Deemed Applicable 
   All clauses were deemed applicable. 
   The following clauses were deemed not applicable. 
List of and rationale for any clauses identified as not applicable 
    
2.  Clauses Tested 
   All clauses were tested
   The following clauses were not tested
List of any clauses not tested. 
3.  Clauses with Failing Results 
   No clauses had failing results
   The following clauses had failing results
List of any clauses with failing results. Descriptions of any failures. 
Modification(s)15 to Test Methods and/or Acceptance Criteria 
   No test methods specified in the standard were modified
   No acceptance criteria specified in the standard were modified
   One or more test methods or acceptance criteria were modified
List of test methods and/or acceptance criteria that were modified. Appropriate supporting 
documents should be attached to this ASCA summary test report including the test plan and 
procedure, acceptance criteria that were applied, and the test results. 
Additional Testing Performed to Demonstrate Conformity with the Standard16
   No additional testing was performed other than that specified in the standard
   Additional testing was performed as specified by the manufacturer to address a 
hazardous situation not specifically addressed by the standard
                                                
15 Modification(s) include special test conditions and additions or modifications to test methods and/or 
acceptance criteria as permitted by IEC 60601-1 subclauses 4.2.3.2 and 4.5 and ISO/IEC 17025 subclause 
7.2.1.4. 
16 For example, clause 4.2 of ANSI/AAMI ES60601 indicates that hazards not specifically addressed in the 
ANSI/AAMI ES60601-1 are to be addressed in the risk management process. 
22 Contains Nonbinding Recommendations 
Description of additional testing performed to address a hazardous situation not specifically 
addressed by the standard. Appropriate supporting documents are attached to this ASCA 
summary test report including the test plan and procedure, acceptance criteria that were 
applied, and the test results. 
Device Configuration(s) and Mode(s) of Operation 
Description of how device was configured including modes of operation used during testing. 
Observations and Degradations During Testing 
   Observations and degradations were NOT found during testing 
   Observations and degradations were found, but deemed acceptable based on the pass/fail 
criteria identified by the device manufacturer
Description of observations and degradations of concern to the testing laboratory but deemed 
acceptable. Example include: 
  Instances of device showing unexpected behaviors (e.g., display of incorrect values, 
display of error messages, device or components need to be restarted, if the device or 
components restart unexpectedly). 
  Instances of device or components being unexpectedly damaged and need replacement 
or other intervention to return to normal operation. 
This list should capture unexpected events. As an example, an error message would be 
unexpected (and therefore would be listed) during EMC testing when a valid input is present; 
conversely, the same error message would be expected (and therefore would not be listed) 
during a test that feeds an out-of-range input to verify the function of input errors. Any 
unexpected behavior is reported even if acceptable per the pass/fail criteria. If the unexpected 
behavior is listed as possible in the labeling (e.g., the device may restart unexpectedly), it 
would still be reported here. 
Modifications to Test Article(s) During Testing 
   No modifications were made to the test articles during testing
   Modifications were made to the test articles during testing. Description of modification 
including their impact on prior test outcome(s) are provided below. 
Description of modifications made to test articles during testing. Description of prior tests that 
were repeated based on modifications made or justification for not repeating prior tests. 
Concerns Identified 
   No concerns were identified.
   Concerns were communicated to the device manufacturer; see list below.
23 Contains Nonbinding Recommendations 
List and description of concerns communicated to the device manufacturer. 
I confirm that: 
 The above summary information includes all original and any retest data
 The above summary information is an accurate representation of the testing conducted
__________________________________________________________________________ 
Name: [TYPED NAME POSITION]               Date 
24