Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

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 [email protected]. For questions about this document regarding CBER-regulated
devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-8354709 or 240-402-8010, or by email at [email protected].
The OMB control number for this information collection is 0910-0889 (expires 06-30-2023).

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Preface

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
[email protected] to receive a copy of the guidance. Please include the document
number 20001 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, [email protected], or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/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 FDA’s
guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.1

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-schemeconformity-assessment-asca-pilot-program

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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 FDA’s 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
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s 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:
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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
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-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-guidancedocuments/standards-development-and-use-standards-regulatory-submissions-reviewed-center-biologicsevaluation Research
3

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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.
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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

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Contains Nonbinding Recommendations

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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.

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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.

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Contains Nonbinding Recommendations

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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.

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Contains Nonbinding Recommendations

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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.

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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 laboratory’s 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 manufacturer’s 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 manufacturer’s risk management process. Nor do they make judgments
concerning the acceptability of risk or the adequacy of the manufacturer’s 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.’ FDA’s references to them for
the ASCA Pilot do not make them legal or regulatory requirements unless specifically identified as such.

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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 manufacturer’s 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 laboratory’s parent organization and, if applicable, other
manufacturers without regard to the impact of the test results on the parent organization’s
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.

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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;

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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 manufacturer’s 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.

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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
FDA’s 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 laboratory’s 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 manufacturer’s 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/recommendedcontent-and-format-non-clinical-bench-performance-testing-information-premarket

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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 report’s 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 customer’s 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 laboratory’s 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 customer’s
responsibility to assess this further.

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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.

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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 FDA’s guidance The
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

B.

Declaration of Conformity

Section IV.A. of FDA’s guidance Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices10 recommends contents for a DOC to an FDArecognized 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 laboratory’s 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 laboratory’s scope of ASCA Accreditation.

C.

Supplemental Documentation

10

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-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 laboratory’s scope of ASCA Accreditation at the time of testing. Circumstances where
FDA may request and review additional information relating to testing from an ASCAaccredited 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
manufacturer’s 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).

11

An ASCA summary test report is different from the test report summary described in FDA’s guidance
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket
Submissions available at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/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,
[email protected]
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 (expires 06-30-2023).

12

Rounded to the nearest whole number.

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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
FDA’s 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 laboratory’s scope of ASCA Accreditation
¨ Standard was in testing laboratory’s 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 FDA’s guidance Appropriate
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Device.

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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)__________

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 7.17.9) 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)______________________________________________

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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 FDA’s 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.
2.
3.
4.
5.

Testing Laboratory Name:
ASCA Testing Laboratory Identification Number:
Testing Location(s):
Testing Date(s):
ASCA Accreditation Status on the Date(s) of Testing:
¨ Standard was *NOT* in testing laboratory’s scope of ASCA Accreditation14
¨ Standard was in testing laboratory’s 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 FDA’s 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 laboratory’s scope of ASCA Accreditation.

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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.

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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.

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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