(30 days)
Not Found
No
The summary describes a system for recording and displaying eye movements, but there is no mention of AI or ML being used for analysis, interpretation, or diagnosis. The device explicitly states it provides no diagnosis and does not provide diagnostic recommendations.
No.
The device is indicated for monitoring and detecting abnormal eye movements, providing data for physician review but explicitly stating it provides no diagnosis and no diagnostic recommendations. It acts as a diagnostic aid rather than directly providing therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This device provides no diagnosis and does not provide diagnostic recommendations." While it monitors and records eye movements relevant to a medical condition, it does not interpret those movements to provide a diagnosis itself.
No
The device description explicitly mentions hardware components like "Vertigo Recording Googles (VRG)" which include a secure holder for the iPhone, LEDs, a macro lens, and a flexible headband. While the system utilizes software on the iPhone and a web-based platform, it is not solely software.
Based on the provided information, the DizzyDoctor® System 1.0.0 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The DizzyDoctor® System monitors eye movements directly from the patient, not from a specimen.
- The intended use is for monitoring eye movements in patients with dizziness. This is a physiological measurement, not a test performed on a biological sample.
- The device description focuses on hardware and software for recording and displaying eye movements. There is no mention of reagents, test kits, or analysis of biological samples.
- The performance studies described are usability and human factors testing, and evaluation of the recordings by audiologists. These are not typical performance studies for an IVD, which would involve analytical and clinical performance testing on specimens.
Therefore, the DizzyDoctor® System 1.0.0 falls under the category of a medical device that monitors physiological function, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.
Using mobile and web-based technology, The DizzyDoctor® System 1.0.0 allows recording of patient of abnormal eye movements in response to standard head positions used for monitoring peripheral vestibular disorders such as Benign Paroxysmal Vertigo. It consists of Vertigo Recording Googles (VRG) with a secure holder for the patient's iPhone Application for step-by-step audio instructions for medically-recognized Dix-Hallpike maneuvers, gyroscopic feedback for enabling correct head positioning, and accurate video-recording of eye movements in response to standard head positions used for assessing balance disorders.
The VRG secure docking station for the iPhone which aligns with the patient's pupil. The VRG has no direct electrical connection with external devices or equipment, and uses light from two LEDs during recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.
Key components of the patient's iPhone support the DizzyDoctor® System 1.0.0 including: an accelerometer and gyroscope, a video camera, storage of video recordings, audio voice/speaker system for real-time interaction with the patient, standard software for downloading and playing mobile applications from external App vendors, software for web-based processes including uploading stored videos.
The DizzyDoctor® Mobile App provides audio support for step-by-step procedures in recording eye movements in relation to positional changes during self-testing, The DizzyDoctor® System is supported by a comprehensive web-based platform for secure patient and physician registration, as well as uploading, processing and downloading videos from the professional- and self-testing for abnormal eye movements. Processed videos are accessed and viewed by physicians on their desk-top office computers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Human Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical office, and in the home setting / physician supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Usability/human factors (engineering) testing was performed in three studies.
Study 1: Testing of 30 unique user interface parameters for the DizzyDoctor® System 1.0.0 was performed in 10 subjects who were vertiginous and 10 who were non-vertiginous users. Results: subjects completed the interface tasks competently. Even though two subjects were observed to have difficulty a task at a particular interface, they were able to self-correct and complete the set-up, self-test and after-test activities completely and accurately.
Study 2: Methodology similar to that in Study 1 was adopted, and this study extended to two audiologists' evaluations of in-use eye movement recordings and nystagmographs from the DizzyDoctor® System and from the predicate device. Results: the audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in the video recordings from the subject and predicate devices.
Study 3: Performed in five subjects using similar methodology as in Studies 1 and 2, but aimed at determining whether changes for a software revision might interfere with functions of the user interface. Results: all subjects accomplished the operational tasks. The software revision used in Study 3 was adopted as the production version of the DDS software (i.e., iOS App and Website/Web portal).
Performance, biocompatibility, electrical safety and electromagnetic compatibility (EMC) testing was undertaken on the DizzyDoctor® System 1.0.0. The device passed all testing and conformance standards listed, and represents a low level of residual risk.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2018
DizzyDoctor® Systems, LLC % Mark Job Responsible Third Party Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K182214
Trade/Device Name: DizzyDoctor® System 1.0.0 Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: June 2, 2018 Received: August 15, 2018
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm_identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html: good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182214
Device Name DizzyDoctor® System 1.0.0
Indications for Use (Describe)
The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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3
510(k) Summary
Date of Summary Preparation: 06/02/2018
1. Submitter Information
DizzyDoctor® Systems, LLC 7625 Mesa College Drive, Suite 200A San Diego, CA 92111
Tel: (858) 223-2172 Contact: Ian Purcell MD, PhD
2. Device Identification
| Proprietary Name: | DizzyDoctor® System 1.0.0 |
|---|---|
| Common Name: | Eye Movement Monitor |
| Classification Name: | Nystagmograph (21CRF 882.1460) |
| Product Code: | GWN |
| Device Class: | Class 2 |
| Panel: | Neurology |
| 3. Predicate Devices: | VisualEYES Video Eye Monitor; K964325; 07/15/1997 |
Micromedical Technologies.
Indications for Use: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in response to standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal and torsional eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.
Device Description: Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.
Using mobile and web-based technology, The DizzyDoctor® System 1.0.0 allows recording of patient of abnormal eye movements in response to standard head positions used for monitoring peripheral vestibular disorders such as Benign Paroxysmal Vertigo. It consists of Vertigo Recording Googles (VRG) with a secure holder for the patient's iPhone Application for step-by-step audio instructions for medically-recognized Dix-Hallpike maneuvers, gyroscopic feedback for enabling correct head positioning, and accurate video-recording of eye movements in response to standard head positions used for assessing balance disorders.
The VRG secure docking station for the iPhone which aligns with the patient's pupil. The VRG has no direct electrical connection with external devices or equipment, and uses light from two LEDs during
4
recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.
Key components of the patient's iPhone support the DizzyDoctor® System 1.0.0 including: an accelerometer and gyroscope, a video camera, storage of video recordings, audio voice/speaker system for real-time interaction with the patient, standard software for downloading and playing mobile applications from external App vendors, software for web-based processes including uploading stored videos.
The DizzyDoctor® Mobile App provides audio support for step-by-step procedures in recording eye movements in relation to positional changes during self-testing, The DizzyDoctor® System is supported by a comprehensive web-based platform for secure patient and physician registration, as well as uploading, processing and downloading videos from the professional- and self-testing for abnormal eye movements. Processed videos are accessed and viewed by physicians on their desk-top office computers.
| VisualEyes Video Monitor | DizzyDoctor® System 1.0.0 eye
movement monitor | Assessment of Substantial
Equivalence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anatomical Site: | | |
| Human Eye | Human Eye | Same |
| Intended Use: | | |
| Support evaluation and
diagnosis of vestibular disorders
from observation of eye
movements from various stimuli | Support evaluation and
diagnosis of vestibular disorders
using standard positional
maneuvers. | Same with respect to stimuli
from positional maneuvers. |
| Indications for Use: | | |
| The Eye Movement Monitor is
used to observe eye movements
from various stimuli used in
vestibular diagnostic testing. It
allows observation of horizontal,
vertical and torsional eye
movements. | The DizzyDoctor® System 1.0.0
is indicated for use in the med-
ical office, and in the home
setting for patients with a
diagnosis of dizziness caused by
peripheral vestibular disorders
who are under the supervision of
a physician. The device detects
abnormal eye movements in
response to standard positional
maneuvers by recording,
tracking, storing and displaying
vertical, horizon-tal and
torsional eye move-ments. This
device provides no diagnosis
and does not provide diagnostic
recommendations.
Caution: Federal law restricts
this device to sale by or on the
order of a physician. | Substantially equivalent, except
for the following differences.
DDS 1.0.0 is intended for use in
the medical office as well as by
the patient in the home setting,
as prescribed by the patient's
doctor. The predicate device is
not used in the home setting.
DDS 1.0.0 is indicated for
monitoring in patients with a
diagnosis of peripheral
vestibular disorders.
DDS 1.0.0 does not support
caloric testing; the predicate
can.
DDS 1.0.0 is a monocular
device; the predicate is
monocular and binocular.
DDS 1.0.0 uploads videos of
eye movement testing in the
medical office or home settings
directly to the DDS website for
viewing by patients or patient's |
| | | physician. For the predicate
access is limited to the doctor,
and remote access to remote in-
home testing observations is not
possible. |
| Intended Use:
For observing eye movements
during vestibular testing to
support diagnostic testing of
vestibule-ocular disorders. | For observing eye movements
during vestibular testing to
support diagnostic testing of
vestibule-ocular disorders. | Substantially equivalent |
| Mechanical Construction:
A light occluding goggle frame
on which a small camera views
the eye. | A light occluding goggle frame
on which a small camera views
the eye. | Substantially equivalent |
| Method of Viewing:
Monocular or binocular | Monocular | Substantially equivalent |
| LED side-lights
Built in light shielding to block
external light | LED side lights built into goggle
Built-in light shielding to block
external light | Substantially equivalent |
| Viewed by direct observation
optionally on video tape with
separate device | Viewed on physician's office
computer or laptop and patient's
computer | Substantially equivalent |
| Power Source/Control:
Mains/electrical outlet | CR2 3V battery | Substantially equivalent |
| On/off button switch on goggles to
start, stop and abort recordings
during Dix-Hallpike and Positional
Tests. | Button switch on googles to turn
LED illumination on/off. Button
on iPhone mounted on google
allows on/off control during
recording sessions. | Substantially equivalent |
| Camera:
Cameras mounted on top of goggles
and close to the forehead | Camera is in patient's or
physician's iPhone, which is
affixed at eye level eye to the
goggle's Mounting Plate that
aligns the iPhone camera to the
patient's eye. | Substantially equivalent |
| Remote Access to Recordings:
Not available | Remote access to eye movement
videos recorded in the home
setting through uploads from the
patient's iPhone to the DDS
website which can be down-
loaded by patients and their
physicians. | Different |
| Human Factors: | | |
| Physician or technician guided
testing in the medical office | Physician or technician guided
testing for first use of the VRG,
and helper-guided testing for in-
home setting | Substantially equivalent
For remote recording in the
home setting, the patient's
helper is trained at the doctor's
office, and supported by audio-
instructions on the iPhone
during positional maneuvers and
eye movement recoding. |
| American National Standard
Institute (ANSI) Procedures
for Testing Basic Vestibular
Function. | | |
| Not reported for predicate by
manufacturer | Conformance by comparative
performance testing of DDS
1.0.0 with predicate for position-
ing and positional Nystagmus.
ANSI S3.45-2009 (2014) | Substantially equivalent |
| Conformance to ISO, IEC,
EN, CISPR, ASTM standards
listed below. | | |
| Not reported for predicate by
manufacturer | Conformance to standards listed
in table below. | Substantially equivalent |
5
6
Testing: Testing showed the DizzyDoctor® System 1.0.0 to be in compliance with standards listed in the table. Quality System Management approaches were employed in the development of the DizzyDoctor® System 1.0.0 per 21CFR 820.
Biocompatibility testing was undertaken for Applied Parts of the VRG that may come in contact with a health professional or patient during testing. The DizzyDoctor® System 1.0.0 complied with the following recognized standards, as listed in the table: ISO10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process; ISO10993-5:2009, Biological Evaluation of Medical Devices- Part 5: Tests for In Vitro Cytotoxicity ISO10993-10:2010; Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization. Additional durability testing of the VRG labels showed them to be resistant to abrasion and peel.
Software verification and validation was undertaken, and documents were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device." The software for this device was considered as a "moderate" level of concern, since a failures or latent design flaws in the software could lead to incorrect or delayed information that could result in non-serious injury of the patient. The device provides no diagnosis, and is one of a battery of tests that are currently used by physicians for vertiginous patients.
Usability/human factors (engineering) testing was performed in three studies. In Study 1, testing of the 30 unique user interface parameters for the DizzyDoctor® System 1.0.0 was performed in 10 subjects who were vertiginous and 10 who were non-vertiginous users. The results revealed that subjects completed the interface tasks competently. Even though two subjects were observed to have difficulty a task at a particular interface, they were able to self-correct and complete the set-up, self-test and after-test activities completely and accurately. In Study 2, methodology similar to that in Study 1 was adopted, and this study extended to two audiologists' evaluations of in-use eye movement recordings and nystagmographs from the DizzyDoctor® System and from the predicate device. The results indicated that
7
the audiologists agreed 100% of the time with respect to the presence or absence of pathological nystagmus in the video recordings from the subject and predicate devices. Study 3 was performed in five subjects using similar methodology as in Studies 1 and 2, but aimed at determining whether changes for a software revision might interfere with functions of the user interface. The results indicated that all subjects accomplished the operational tasks. The software revision used in Study 3 was adopted as the production version of the DDS software (i.e., iOS App and Website/Web portal).
Performance, biocompatibility, electrical safety and electromagnetic compatibility (EMC) testing was undertaken on the DizzyDoctor® System 1.0.0, as itemized in the table below, in accordance with the requirements of the design control regulations and established quality assurance procedures. The device passed all testing and conformance standards listed, and represents a low level of residual risk.
Conclusion: The DizzyDoctor® System 1.0.0 Eye Movement Monitor is substantially equivalent to the predicate device.
| # | Standard | Name | Date | FDA
Recog-
nition |
|--------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------|
| 1 | IEC 60601-1:2005
+CORR 2006
+CORR 2:2007 +
AM1:2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance. | 2012 | 19-4 |
| 2 | 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. | 2015 | 19-6 |
| 3 | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests. | 2014 | 19-8 |
| 4 | CISPR
11:2009+A1:2010 | Industrial, scientific and medical (ism) radio
frequency equipment - radio disturbance
characteristics - limits and methods of
measurement. | 2009 | No |
| 5 | IEC 61000-4-2:2008 | Electromagnetic compatibility - testing and
measurement techniques - electrostatic discharge
immunity test. | 2008 | No |
| 6 | IEC 61000-4-3:2006
A1:2007 + A2:2010 | Electromagnetic compatibility - testing and
measurement techniques -radiated radio frequency
electromagnetic field immunity test. | 2006 | No |
| 7 | IEC 61000-4-4:2011 | Electromagnetic compatibility - testing and
measurement techniques - electrical fast transient /
burst immunity. | 2011 | No |
| 8 | IEC 61000-4-5:2005 | Electromagnetic compatibility - testing and
measurement techniques - surge immunity test. | 2005 | No |
| 9 | IEC 61000-4-6:2003
- A1:2004 +
A2:2006 | Electromagnetic compatibility, testing and
measurement techniques, conducted radio
frequency electromagnetic field, immunity test. | 2003 | No |
| 10 | IEC 61000-4-8:2009 | Electromagnetic compatibility - testing and
measurement techniques - for power frequency
magnetic field, immunity test. | 2009 | No |
| 11 | IEC 61000-4-
11:2004 | Electromagnetic compatibility - testing and
measurement techniques - voltage dips, short
interruptions and voltage variations immunity tests. | 2004 | No |
| 12 | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing Within a Risk Management
Process. (Biocompatibility) | 2009 | 2-156 |
| 13 | ISO 10993-5 | Biological evaluation of medical devices - part 5:
tests for in vitro cytotoxicity. | 2009 | 2-153 |
| 14 | ISO 10993-10 | Biological evaluation of medical devices - part 10:
tests for irritation and skin sensitization. | 2010 | 2-173 |
| 15 | ASTM D903 | Standard Test Method for Peel or Stripping
Strength of Adhesive Bonds. | 2010 | 5-42 |
| 16 | ASTM D1319 | Standard Test Method for Hydrocarbon Types in
Liquid Petroleum Products by Fluorescent Indicator
Adsorption, as modified Crock Test - Dry Rub &
Wet Rub | 2015 | No |
| 17 | ASTM 5135 | Standard Test Method for Analysis of Styrene by
Capillary Gas Chromatography. | 2016 | No |
| 18 | IEC 61000-4-28 | Electromagnetic compatibility (EMC) - Part 4-28:
Testing and measurement techniques - Variation of
power frequency, immunity test for equipment with
input current not exceeding 16 A per phase. | 2009 | No |
| 19 | ISO 14971:2007 | Medical devices - Application of risk management
to medical devices. | 2007 | 5-40 |
| 20 | ISO 15223 | BS EN ISO 15223-1: 2016. Medical devices—
Symbols to be used with medical device labels,
labeling and information to be supplied. Part 1:
General requirements, ISO 7000 Reg. No. 1641. | 2016 | 5-117 |
| 21 | EN 50419 | BS EN 50419:2006. Marking of electrical and
electronic equipment in accordance with Article
11(2) of Directive 2002/96/EC (WEEE). | 2002 | No |
| 22 | ANSI S3.45-2009
(Reaffirmed 2014) | American National Standard Procedures for Testing
Basic Vestibular Function. (Dental/ENT):
Positioning and Positional Nystagmus. | 2014 | 4-185 |
| END OF DOCUMENT
vf_06012018 | | | | |
8
vf_06012018