Attachment_(4)_-_CLRF_IC_FDA_Compliance_Checklist_1_Jul_2014.pdf

FDA COMPLIANCE CHECKLIST

This FDA Compliance Checklist serves as an evaluation tool to determine if the evaluated laser system adheres to the performance requirements listed in 21 CFR 1040.10 and the labeling requirements listed in 21 CFR 1010.2 and 1010.3.

DoN Laser Safety LNTL wishes to thank AFRL/RHDO for the template used to modify this form.

LASER SYSTEMS DESCRIPTION

Type:

CLASSIFICATION DESIGNATION

Class I Class IIa Class II Class IIIa Class IIIb Class IV gfedc gfedc gfedc

PERFORMANCE REQUIREMENTS

1. Protective Housing - All Classes

Compliant Non-Compliant N/A

2. Safety interlocks - All Classes

1040.10(f)(1) -Protective housing. Each laser product shall have a protective housing that prevents human access during operation to laser and collateral radiation that exceed the limits of Class I and Table VI, respectively, wherever and whenever such human access is not necessary for the product to perform its intended function. Wherever and whenever human access to laser radiation levels that exceed the limits of Class I is necessary, these levels shall not exceed the limits of the lowest class necessary to perform the intended function(s) of the product.

gfedc gfedc gfedc

Comments:

1040.10(f)(2) - Safety interlocks.

(i) Each laser product, regardless of its class, shall be provided with at least one safety interlock for each portion of the protective housing which is designed to be removed or displaced during operation or maintenance, if removal or displacement of the protective housing could permit, in the absence of such interlock(s), human access to laser or collateral radiation in excess of the accessible emission limit applicable under paragraph (f)(1) of this section.

(ii) Each required safety interlock, unless defeated, shall prevent such human access to laser and collateral radiation upon removal or displacement of such portion of the protective housing

(iii) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing shall be provided, if failure of a single interlock would allow;

(a) Human access to a level of laser radiation in excess of the accessible emission limits of Class IIIa; or

(b) Laser radiation in excess of the accessible emission limits of Class II to be emitted directly through the opening created by removal or displacement of the interlocked portion of the protective housing.

(iv) Laser products that incorporate safety interlocks designed to allow safety interlock defeat shall incorporate a thomas.fraser Text Box A-1

**NOTE: Requirements are dependant on class of internal radiation**

2.1 Non-defeatable Interlocks

Compliant Non-Compliant N/A

2.2 Defeatable Interlocks

Compliant Non-Compliant N/A

3. Remote Interlock Connector - Class IIIb & IV

Compliant Non-Compliant N/A

4. Key Control - Class IIIb & IV

Compliant Non-Compliant N/A means of visual or aural indication of interlock defeat. During interlock defeat, such indication shall be visible or audible whenever the laser product is energized, with and without the associated portion of the protective housing removed or displaced.

(v) Replacement of a removed or displaced portion of the protective housing shall not be possible while required safety interlocks are defeated.

gfedc gfedc gfedc

Comments:

gfedc gfedc gfedc

Comments:

1040.10(f)(3) - Remote interlock connector. Each laser system classified as a Class IIIb or IV laser product shall incorporate a readily available remote interlock connector having an electrical potential difference of no greater than 130 root mean-square volts between terminals. When the terminals of the connector are not electrically joined, human access to all laser and collateral radiation from the laser product in excess of the accessible emission limits of Class I and Table VI shall be prevented.

gfedc gfedc gfedc

Comments:

1040.10(f)(4) - Key control. Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-2

5. Emission Indicator - Class II, IIIa, IIIb & IV

5.1 Class II & IIIa: no delay

Compliant Non-Compliant N/A

5.2 Class IIIb & IV: with delay

Compliant Non-Compliant N/A

5.3 Indicator on laser and controls, if separated by more than 2 meters

Compliant Non-Compliant N/A

1040.10(f)(5)(i) - Laser radiation emission indicator. (i) Each laser system classified as a Class II or IIIa laser product shall incorporate an emission indicator that provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I.

gfedc gfedc gfedc

Comments:

1040.10(f)(5)(ii) - Laser radiation emission indicator. (ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emission indicator which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow appropriate action to avoid exposure to the laser radiation.

gfedc gfedc gfedc

Comments:

1040.10(f)(5)(iii) - Laser radiation emission indicator. (iii) For laser systems manufactured on or before August 20, 1986, if the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters, both laser and laser energy source shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section. For laser systems manufactured after August 20, 1986, each separately housed laser and operation control of a laser system that regulates the laser or collateral radiation emitted by a product during operation shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section, if the laser or operation control can be operated at a separation distance greater than 2 meters from any other separately housed portion of the laser product incorporating an emission indicator.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-3

**NOTE: Class IIa is exempt**

5.4 Indicator visible through protective eyewear

Compliant Non-Compliant N/A

5.5 Indicator in safe viewing position

Compliant Non-Compliant N/A

6. Beam Attenuator - Class II, IIIa, IIIb & IV

Compliant Non-Compliant N/A

1040.10(f)(5)(iv) - Laser radiation emission indicator. (iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of this section shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiation.

gfedc gfedc gfedc

Comments:

1040.10(f)(5)(v) - Laser radiation emission indicator. (v) Emission indicators required by paragraph (f)(5) (i) or (ii) of this section shall be located so that viewing does not require human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI.

gfedc gfedc gfedc

Comments:

1040.10(f)(6) - Beam attenuator.

(i) Each laser system classified as a Class II, III, or IV laser product shall be provided with one or more permanently attached means, other than laser energy source switch(es), electrical supply main connectors, or the key-actuated master control, capable of preventing access by any part of the human body to all laser and collateral radiation in excess of the accessible emission limits of Class I and Table VI.

(ii) If the configuration, design, or function of the laser product would make unnecessary compliance with the requirement in paragraph (f)(6)(i) of this section, the Director, Office of Compliance (HFZ–300), Center for Devices and Radiological Health, may, upon written application by the manufacturer, approve alternate means to accomplish the radiation protection provided by the beam attenuator.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-4

7. Location of Controls - Class IIa, II, IIIa, IIIb & IV

Compliant Non-Compliant N/A

8. Viewing Optics - All Classes

Compliant Non-Compliant N/A

9. Scanning Safeguard - All Classes

Compliant Non-Compliant N/A

10. Manual Reset Mechanism - Class IV

1040.10(f)(7) - Location of controls. Each Class IIa, II, III, or IV laser product shall have operational and adjustment controls located so that human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI is unnecessary for operation or adjustment of such controls.

gfedc gfedc gfedc

Comments:

1040.10(f)(8) -Viewing optics. All viewing optics, viewports, and display screens incorporated into a laser product, regardless of its class, shall limit the levels of laser and collateral radiation accessible to the human eye by means of such viewing optics, viewports, or display screens during operation or maintenance to less than the accessible emission limits of Class I and Table VI. For any shutter or variable attenuator incorporated into such viewing optics, viewports, or display screens, a means shall be provided:

(i) To prevent access by the human eye to laser and collateral radiation in excess of the accessible emission limits of Class I and Table VI whenever the shutter is opened or the attenuator varied.

(ii) To preclude, upon failure of such means as required in paragraph (f)(8)(i) of this section, opening the shutter or varying the attenuator when access by the human eye is possible to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI.

gfedc gfedc gfedc

Comments:

1040.10(f)(9) - Scanning safeguard. Laser products that emit accessible scanned laser radiation shall not, as a result of any failure causing a change in either scan velocity or amplitude, permit human access to laser radiation in excess of:

(i) The accessible emission limits of the class of the product, or

(ii) The accessible emission limits of the class of the scanned laser radiation if the product is Class IIIb or IV and the accessible emission limits of Class IIIa would be exceeded solely as result of such failure.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-5

Compliant Non-Compliant N/A

1040.10(f)(10) -Manual reset mechanism. Each laser system manufactured after August 20, 1986, and classified as a Class IV laser product shall be provided with a manual reset to enable resumption of laser radiation emission after interruption of emission caused by the use of a remote interlock or after an interruption of emission in excess of 5 seconds duration due to the unexpected loss of main electrical power.

gfedc gfedc gfedc

Comments:

LABEL REQUIREMENTS

11. Certification Label - All Classes - 1010.2

Compliant Non-Compliant N/A

12. Identification Label - All Classes - 1010.3

1010.2 - Certification.

(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.

(b) The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language.

(c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter.

(d) In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided.

gfedc gfedc gfedc

Comments:

1010.3 - Identification.

(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language.

(1) The full name and address of the manufacturer of the product; abbreviations such as ‘‘Co.,’’ ‘‘Inc.,’’ or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name thomas.fraser

A-6

Compliant Non-Compliant N/A

13. Class Designation and Warning Label - All Classes except Class I - 1040.10(g)

13.1 Class IIa and II Designations and Warnings

Compliant Non-Compliant N/A other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously supplied the Director, Center for Devices and Radiological Health with sufficient information to identify the manufacturer of the product.

(2) The place and month and year of manufacture:

(i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.

(ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows:

MANUFACTURED: (INSERT MONTH AND

YEAR OF MANUFACTURE.)

(b) In the case of products for which it is not feasible to affix identification labeling in accordance with paragraph

(a) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such identification may be provided.

(c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured.

gfedc gfedc gfedc

Comments:

1040.10(g) -Labeling requirements. In addition to the requirements of §§ 1010.2 and 1010.3, each laser product shall be subject to the applicable labeling requirements of this paragraph.

1040.10(g)(1) -Class IIa and II designations and warnings.

(i) Each Class IIa laser product shall have affixed a label bearing the following wording: ‘‘Class IIa Laser Product— Avoid Long-Term Viewing of Direct Laser Radiation.’’

(ii) Each Class II laser product shall have affixed a label bearing the warning logotype A (Figure 1 of 21 CFR 1040.10) and including the following wording:

[Position I on the logotype]

‘‘LASER RADIATION—DO NOT

STARE INTO BEAM’’; and [Position 3 on the logotype]

‘‘CLASS II LASER PRODUCT’’.

thomas.fraser

A-7

13.2 Class IIIa and IIIb Designations and Warnings

Compliant Non-Compliant N/A

13.3 Class IV Designation and Warning

Comments:

1040.10(g)(2) - Class IIIa and IIIb designations and warnings.

(i) Each Class IIIa laser product with an irradiance less than or equal to 2.5x10-3 W cm-2 shall have affixed a label bearing the warning logotype A (Figure 1 of 21 CFR 1040.10) and including the following wording:

[Position 1 on the logotype]

‘‘LASER RADIATION—DO NOT

STARE INTO BEAM OR VIEW DIRECTLY

WITH OPTICAL INSTRUMENTS’’; and, ‘‘CLASS IIIa LASER PRODUCT’’.

(ii) Each Class IIIa laser product with an irradiance greater than 2.5x10-3 W cm-2 shall have affixed a label bearing the warning logotype B (Figure 2 in this paragraph) and including the following wording:

‘‘LASER RADIATION—AVOID

DIRECT EYE EXPOSURE’’; and, ‘‘CLASS IIIa LASER PRODUCT’’.

(iii) Each Class IIIb laser product shall have affixed a label bearing the warning logotype B (Figure 2 of 21 CFR 1040.10) and including the following wording:

‘‘LASER RADIATION—AVOID

DIRECT EXPOSURE TO BEAM’’; and, [Position 3 on the logotype] ‘‘CLASS IIIb LASER PRODUCT’’.

gfedc gfedc gfedc

Comments:

1040.10(g)(3) -Class IV designation and warning. Each Class IV laser product shall have affixed a label bearing the warning logotype B (Figure 2 of 21 CFR 1040.10), and including the following wording:

‘‘LASER RADIATION—AVOID EYE OR

thomas.fraser

A-8

Compliant Non-Compliant N/A

14. Radiation Output Information (Position 2 on Label) - Classes II, IIIa, IIIb & IV

Compliant Non-Compliant N/A

**NOTE: Class IIa is exempt**

15. Aperture Label - Classes II, IIIa, IIIb & IV

Compliant Non-Compliant N/A

16. Non-Interlocked Protective Housing Labels - All Classes

SKIN EXPOSURE TO DIRECT OR

SCATTERED RADIATION’’; and, [Position 3 on the logotype]

‘‘CLASS IV LASER PRODUCT’’.

gfedc gfedc gfedc

Comments:

1040.10(g)(4) - Radiation output information on warning logotype. Each Class II, III, and IV laser product shall state in appropriate units, at position 2 on the required warning logotype, the maximum output of laser radiation, the pulse duration when appropriate, and the laser medium or emitted wavelength(s).

gfedc gfedc gfedc

Comments:

1040.10(g)(5) -Aperture label. Each laser product, except medical laser products and Class IIa laser products, shall have affixed, in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI of paragraph (d) of this section, a label(s) bearing the following wording as applicable.

(i) ‘‘AVOID EXPOSURE—Laser radiation is emitted from this aperture,’’ if the radiation emitted through such aperture is laser radiation.

(ii) ‘‘AVOID EXPOSURE—Hazardous electromagnetic radiation is emitted from this aperture,’’ if the radiation emitted through such aperture is collateral radiation described in Table VI, item 1.

(iii) ‘‘AVOID EXPOSURE—Hazardous x-rays are emitted from this aperture,’’ if the radiation emitted through such aperture is collateral radiation described in Table VI, item 2.

gfedc gfedc gfedc

Comments:

1040.10(g)(6) -Labels for noninterlocked protective housings. For each laser product, labels shall be provided for each portion of the protective housing which has no safety interlock and which is designed to be displaced or removed thomas.fraser

A-9

Compliant Non-Compliant N/A

17. Defeatably Interlocked Protective Housing Labels - All Classes

Compliant Non-Compliant N/A during operation, maintenance, or service, and thereby could permit human access to laser or collateral radiation in excess of the limits of Class I and Table VI. Such labels shall be visible on the protective housing prior to displacement or removal of such portion of the protective housing and visible on the product in close proximity to the opening created by removal or displacement of such portion of the protective housing, and shall include the wording:

(i) ‘‘CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM.’’ for Class II accessible laser radiation.

(ii) ‘‘CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.’’ for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5x10-3 W cm-2.

(iii) ‘‘DANGER—Laser radiation when open. AVOID DIRECT EYE EXPOSURE.’’ for Class IIIa accessible laser radiation with an irradiance greater than 2.5x10-3 W cm-2.

(iv) ‘‘DANGER—Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM.’’ for Class IIIb accessible laser radiation.

(v) ‘‘DANGER—Laser radiation when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.’’ for Class IV accessible laser radiation.

(vi) ‘‘CAUTION—Hazardous electromagnetic radiation when open.’’ for collateral radiation in excess of the accessible emission limits in Table VI, item 1 of paragraph (d) of this section.

(vii) ‘‘CAUTION—Hazardous x-rays when open.’’ for collateral radiation in excess of the accessible emission limits in Table VI, item 2 of paragraph (d) of this section.

gfedc gfedc gfedc

Comments:

1040.10(g)(7) -Labels for defeatably interlocked protective housings. For each laser product, labels shall be provided for each defeatably interlocked (as described in paragraph (f)(2)(iv) of this section) portion of the protective housing which is designed to be displaced or removed during operation, maintenance, or service, and which upon interlock defeat could permit human access to laser or collateral radiation in excess of the limits of Class I or Table VI. Such labels shall be visible on the product prior to and during interlock defeat and in close proximity to the opening created by the removal or displacement of such portion of the protective housing, and shall include the wording:

(i) ‘‘CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM.’’ for Class II accessible laser radiation.

(ii) ‘‘CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.’’ for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5x10-3 W cm-2.

(iii) ‘‘DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EYE EXPOSURE.’’ for Class IIIa accessible laser radiation when an irradiance greater than 2.5x10-3 W cm-2.

(iv) ‘‘DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EXPOSURE TO BEAM.’’ for Class IIIb accessible laser radiation.

(v) ‘‘DANGER—Laser radiation when open and interlock defeated. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.’’ for Class IV accessible laser radiation.

(vi) ‘‘CAUTION—Hazardous electromagnetic radiation when open and interlock defeated.’’ for collateral radiation in excess of the accessible emission limits in Table VI. item 1 of paragraph (d) of this section.

(vii) ‘‘CAUTION—Hazardous x-rays when open and interlock defeated.’’ for collateral radiation in excess of the accessible emission limits in Table VI. item 2 of paragraph (d) of this section.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-10

18. Warning for Visible/Invisible Radiation - All Classes

Compliant Non-Compliant N/A

19. Positioning of Labels - All Classes

Compliant Non-Compliant N/A

20. Label Specifications - All Classes

Compliant Non-Compliant N/A

1040.10(g)(8) -Warning for visible and/or invisible radiation. On the labels specified in this paragraph, if the laser or collateral radiation referred to is:

(i) Invisible radiation, the word ‘‘invisible’’ shall appropriately precede the word ‘‘radiation’’; or

(ii) Visible and invisible radiation, the words ‘‘visible and invisible’’ or ‘‘visible and/or invisible’’ shall appropriately precede the word ‘‘radiation.’’

(iii) Visible laser radiation only, the phrase ‘‘laser light’’ may replace the phrase ‘‘laser radiation.’’ gfedc gfedc gfedc

Comments:

1040.10(g)(9) -Positioning of labels. All labels affixed to a laser product shall be positioned so as to make unnecessary, during reading, human exposure to laser radiation in excess of the accessible emission limits of Class I radiation or the limits of collateral radiation established to Table VI of paragraph (d) of this section.

gfedc gfedc gfedc

Comments:

1040.10(g)(10) -Label specifications. Labels required by this section and § 1040.11 shall be permanently affixed to, or inscribed on, the laser product, legible, and clearly visible during operation, maintenance, or service, as appropriate. If the size, configuration, design, or function of the laser product would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, the Director, Office of Compliance (HFZ–300), Center for Devices and Radiological Health, on the Director’s own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s) or alternate wording for such label(s) as applicable.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-11

Information Requirements

21. User Information

Compliant Non-Compliant N/A

21.1 Operator & Maintenance Instructions

Compliant Non-Compliant N/A

21.2 Statement of Parameters

Compliant Non-Compliant N/A

21.3 Label Reproductions

1040.10(h)(1) -Informational requirements—(1) User information. Manufacturers of laser products shall provide as an integral part of any user instruction or operation manual which is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each laser product:

gfedc gfedc gfedc

Comments:

1040.10(h)(1)(i) - Adequate instructions for assembly, operation, and maintenance, including clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in Tables I, II-A, II, III–A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11.

gfedc gfedc gfedc

Comments:

1040.10(h)(1)(ii) - A statement of the magnitude, in appropriate units, of the pulse durations(s), maximum radiant power and, where applicable, the maximum radiant energy per pulse of the accessible laser radiation detectable in each direction in excess of the accessible emission limits in Table I of paragraph (d) of this section determined under paragraph (e) of this section.

gfedc gfedc gfedc

Comments:

1040.10(h)(1)(iii) - Legible reproductions (color optional) of all labels and hazard warnings required by paragraph (g) of this section and § 1040.11 to be affixed to the laser product or provided with the laser product, including the information required for positions 1, 2, and 3 of the applicable logotype (Figure 1 of paragraph (g)(1)(ii) or Figure 2 or paragraph (g)(2)(ii) of this section). The corresponding position of each label affixed to the product shall be indicated thomas.fraser

A-12

Compliant Non-Compliant N/A

21.4 Listing of Controls, Adjustments, and Procedures, including Warnings

Compliant Non-Compliant N/A

21.5 Use with Optical Instrument Warning

Compliant Non-Compliant N/A

22. Service Information or, if provided with the product, a statement that such labels could not be affixed to the product but were supplied with the product and a statement of the form and manner in which they were supplied shall be provided.

gfedc gfedc gfedc

Comments:

1040.10(h)(1)(iv) - A listing of all controls, adjustments, and procedures for operation and maintenance, including the warning ‘‘Caution—use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.’’ gfedc gfedc gfedc

Comments:

1040.10(h)(1)(vi) - In the case of laser products classified with a 7 millimeter diameter aperture stop as provided in paragraph (e)(3)(i) of this section, if the use of a 50 millimeter diameter aperture stop would result in a higher classification of the product, the following warning shall be included in the user information: ‘‘CAUTION—The use of optical instruments with this product will increase eye hazard.’’ gfedc gfedc gfedc

Comments:

1040.10(h)(2) -Purchasing and servicing information. Manufacturers of laser products shall provide or cause to be provided:

(i) In all catalogs, specification sheets, and descriptive brochures pertaining to each laser product, a legible reproduction (color optional) of the class designation and warning required by paragraph (g) of this section to be affixed to that product, including the information required for positions 1, 2, and 3 of the applicable logotype (Figure 1 of paragraph (g)(1)(ii) or Figure 2 of paragraph (g)(2)(ii) of this section).

(ii) To servicing dealers and distributors and to others upon request at a cost not to exceed the cost of preparation and distribution, adequate instructions for service adjustments and service procedures for each laser product model, including clear warnings and precautions to be taken to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in Tables I, II–A, II, III–A, III–B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11; and in all such thomas.fraser

A-13

Compliant Non-Compliant N/A service instructions, a listing of those controls and procedures that could be utilized by persons other than the manufacturers or the manufacturer’s agents to increase accessible emission levels of radiation and a clear description of the location of displaceable portions of the protective housing that could allow human access to laser or collateral radiation in excess of the accessible emission limits in Tables I, II–A, II, III–A, III–B, and VI of paragraph (d) of this section. The instructions shall include protective procedures for service personnel to avoid exposure to levels of laser and collateral radiation known to be hazardous for each procedure or sequence of procedures to be accomplished, and legible reproductions (color optional) of required labels and hazard warnings.

gfedc gfedc gfedc

Comments:

thomas.fraser

A-14