Ophthalmic Instruments 10-51 Ophth
15004-2
Fundamental requirements and test
First
12/19/2007 ISO
methods Part 2: Light hazard
edition
protection
2007-02-15
Recognition List Number: 019 Publication Date: 12/19/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-51: ISO 15004-2 First edition 2007-02-15, Ophthalmic
Instruments - Fundamental requirements and test methods Part 2: Light hazard
protection. (Ophthalmic)
Date of Standard: 2007.
Address of Standards Organization:
International Organization for Standardization (ISO)*
1, Rue de Varembe
Case Postale 56
CH 1211 Geneva 20, 0
SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
All ophthalmic instruments that direct optical radiation at or into the eye including
but not limited to: Direct Opthalmoscopes, AC and DC Powered, Indirect,
Opthalmoscopes, AC and DC Powerd, Slit Lamps, Fundus Cameras, Specular
Microscopes, Endoilluminators, Operation Microscopes for ocular surgery.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
International, Horizontal
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device
Class
Product
Code
§876.150021 Endoilluminator
Class 2 MPA22
§876.150023 Endoilluminator, Reprocessed
Class 2 NKZ24
Regulation
Device
Number
Device Name
Class
Product
Code
§878.470025 Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 HRM26
§878.470027 Microscope, Operating, Non-Electric, Ophthalmic
Class 1 HRB28
§878.470029 Microscope, Surgical, General & Plastic Surgery
Class 1 FSO30
Regulation
Device
Number
Device Name
Class
Product
Code
§886.112031 Camera, Ophthalmic, Ac-Powered
Class 2 HKI32
Regulation
Device
Number
Device Name
Class
Product
Code
§886.157033 Ophthalmoscope, Ac-Powered
Class 2 HLI34
§886.157035 Ophthalmoscope, Battery-Powered
Class 2 HLJ36
§886.157037 Ophthalmoscope,Laser,Scanning
Class 2 MYC38
Regulation
Device
Number
Device Name
Class
Product
Code
§886.178039 Retinoscope, Ac-Powered
Class 2 HKL40
§886.178041 Retinoscope, Battery-Powered
Class 1 HKM42
Regulation
Device
Device Name
Product
Number
Class
§886.185043 Biomicroscope, Slit-Lamp, Ac-Powered
Class 2 HJO44
§886.185045 Device,Analysis,Anterior Segment
Class 2 MXK46
§886.185047 Microscope, Specular
Class 2 NQE48
Relevant Guidance:
There is no relevant guidance developed at this time.
Code
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR876.1500]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES
Subpart B--Diagnostic Devices
Sec. 876.1500 Endoscope and accessories.
(a)Identification. An endoscope and accessories is a device used to provide
access, illumination, and allow observation or manipulation of body
cavities, hollow organs, and canals. The device consists of various rigid
or flexible instruments that are inserted into body spaces and may include
an optical system for conveying an image to the user's eye and their
accessories may assist in gaining access or increase the versatility and
augment the capabilities of the devices. Examples of devices that are
within this generic type of device include cleaning accessories for
endoscopes, photographic accessories for endoscopes, nonpowered
anoscopes, binolcular attachments for endoscopes, pocket battery boxes,
flexible or rigid choledochoscopes, colonoscopes, diagnostic
cystoscopes, cystourethroscopes, enteroscopes,
esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic
illuminators for endoscopes, incandescent endoscope lamps, biliary
pancreatoscopes, proctoscopes, resectoscopes, nephroscopes,
sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers,
cytology brushes for endoscopes, and lubricating jelly for transurethral
surgical instruments. This section does not apply to endoscopes that have
specialized uses in other medical specialty areas and that are covered
by classification regulations in other parts of the device classification
regulations.
(b)Classification. (1) Class II (performance standards).
(2) Class I for the photographic accessories for endoscope, miscellaneous
bulb adapter for endoscope, binocular attachment for endoscope, eyepiece
attachment for prescription lens, teaching attachment, inflation bulb,
measuring device for panendoscope, photographic equipment for physiologic
function monitor, special lens instrument for endoscope, smoke removal
tube, rechargeable battery box, pocket battery box, bite block for
endoscope, and cleaning brush for endoscope. The devices subject to this
paragraph (b)(2) are exempt from the premarket notification procedures
in subpart E of part 807of this chapter, subject to the limitations in
876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66
FR 38801, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR878.4700]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES
Subpart E--Surgical Devices
Sec. 878.4700 Surgical microscope and accessories.
(a)Identification. A surgical microscope and accessories is an AC-powered
device intended for use during surgery to provide a magnified view of the
surgical field.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter, subject to the limitations in 878.9.
[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66
FR 38803, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR886.1120]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 886 -- OPHTHALMIC DEVICES
Subpart B--Diagnostic Devices
Sec. 886.1120 Ophthalmic camera.
(a)Identification. An ophthalmic camera is an AC-powered device intended
to take photographs of the eye and the surrounding area.
(b)Classification. Class II.
[55 FR 48441, Nov. 20, 1990]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR886.1570]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 886 -- OPHTHALMIC DEVICES
Subpart B--Diagnostic Devices
Sec. 886.1570 Ophthalmoscope.
(a)Identification. An ophthalmoscope is an AC-powered or
battery-powered device containing illumination and viewing optics
intended to examine the media (cornea, aqueous, lens, and vitreous)
and the retina of the eye.
(b)Classification. Class II.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR886.1780]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 886 -- OPHTHALMIC DEVICES
Subpart B--Diagnostic Devices
Sec. 886.1780 Retinoscope.
(a)Identification. A retinoscope is an AC-powered or battery-powered
device intended to measure the refraction of the eye by illuminating the
retina and noting the direction of movement of the light on the retinal
surface and of the refraction by the eye of the emergent rays.
(b)Classification. (1) Class II (special controls) for the AC-powered
device.
(2) Class I (general controls) for the battery-powered device. The class
I battery-powered device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to 886.9. The
battery-powered device is exempt from the current good manufacturing
practice requirements of the quality system regulation in part 820 of this
chapter, with the exception of 820.180 of this chapter, with respect to
general requirements concerning records, and 820.198 of this chapter, with
respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at
65 FR 2320, Jan. 14, 2000]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR886.1850]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 886 -- OPHTHALMIC DEVICES
Subpart B--Diagnostic Devices
Sec. 886.1850 AC-powered slitlamp biomicroscope.
(a)Identification. An AC-powered slitlamp biomicroscope is an
AC-powered device that is a microscope intended for use in eye
examination that projects into a patient's eye through a control
diaphragm a thin, intense beam of light.
(b)Classification. Class II.