ANSI Z136.3 - General Information

Question 1

What laser classifications require administrative controls?

Answer 1

1M, 2M, 3B, 4

Question 2

What laser classifications require training?

Answer 2

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

Question 3

What laser classifications require an LSO?

Answer 3

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

Question 4

What laser classifications require engineering controls?

Answer 4

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

Question 5

What is the national standard for classification for …

Class 1

IAW ANSI Z136.1-2014

Answer 5

Any laser, or system constaining a laser, that cannot emit laser radiation at levels that are known to cause eye or skin injury during normal operation.

This does not apply to maintenance and/or service states requiring access to higher-class lasers enclosed or embedded in Class 1 systems.

Question 6

What is the national standard for classification for …

Class 1M

IAW ANSI Z136.1-2014

Answer 6

Considered incapable of producing hazardous exposure unless viewed with collecting optics.

Question 7

What is the national standard for classification for …

Class 2

IAW ANSI Z136.1-2014

Answer 7

Visible lasers considered incapable of emitting laser radiation at levels that are known to cause skin or eye injury within the aversion response time of the human eye (0.25 s).

Question 8

What is the national standard for classification for …

Class 2M

IAW ANSI Z136.1-2014

Answer 8

Emits in the visible portion of the spectrum, and is potentially hazardous if viewed with collecting optics

Question 9

What is the national standard for classification for …

Class 3R

IAW ANSI Z136.1-2014

Answer 9

A laser system that is potentially hazardous under some direct and secular reflection viewing conditions if the eye is appropriately focused and stable.

Question 10

What is the national standard for classification for …

Class 3B

IAW ANSI Z136.1-2014

Answer 10

Medium-powered lasers (visible or invisible) that present a potential eye hazard for intrabeam (direct) viewing or for viewing specular (mirror-like) reflections.

Class 3B lasers do not present a diffuse (scatter) reflection hazard or significant skin hazard except for higher-powered Class 3B lasers operating in certain wavelength regions.

Question 11

What is the national standard for classification for …

Class 4

IAW ANSI Z136.1-2014

Answer 11

High-powered lasers (visible or invisible) that present a potential acute hazard to the eye and skin for both direct (intrabeam) exposure and for exposure to diffuse (scatter) reflections.

Class 4 lasers also present a potential hazard for fire (ignition) and by-product emissions from target or process materials

Question 12

Who is required to supply the HCLS laser hazard classification?

Answer 12

Manufacturer

Question 13

What is required if a HCLS does not have a hazard classification or the HCLS has been modified?

Answer 13

The classification shall be determined by the LSO

Question 14

What is the “stepwise procedure for hazard classification”?

Answer 14

1. Determine the hazard class of the HCLS as certified by the manufacturer in accordance with 21CFR1040.10
2. Comply with the control measures recommended for the appropriate laser class

Question 15

What are the two broad categories of hazards that HCLSs can be divided into?

Answer 15

1. Retinal hazard region (roughly 400 nm to 1400 nm), in which a focal image on the retina presents the main hazard
2. Those in the ultraviolet and far-infrared regions, in which the main hazard is to the cornea and skin

Question 16

Federal Regulations

Answer 16

Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has the responsibility for implementing and enforcing 21CFR1040.10 and the sections of the Food, Drug and Cosmetic Act applicable to medical devices.

Question 17

Non-governmental Controls

Answer 17

The Joint Commission (TJC)
Association of Surgical Technologists (AST)
Association of periOperative Registered Nurses (AORN)
American Society for Lasers in Medicine and Surgery (ASLMS)
Academy of Laser Dentistry (ALD)

These non-governmental organizations have recommended practices, guidelines, or position statements associated with their disciplines and laser uses.

Question 18

Deputy Laser Safety Officer (DLSO)

Answer 18

If deemed necessary, a DLSO should b e appointed b y management or the LSO to perform the duties and fulfill the responsibilities of the LSO when the LSO is not available.

For facilities with multiple divisions or locations, a system of DLSOs may be deemed necessary.

The DLSO can be the laser user, laser operator, or other trained person responsible for the laser safety program.

Question 19

Laser Safety Site Contact (LSSC)

… sometimes referred to as the Laser Safety Specialist (LSS)

Answer 19

The LSSC/LSS oversees the safe laser use in specific areas where a laser is used and for which the LSSC/LSS is responsible.

An LSSC/LSS may not be needed where the laser is used only in one location and the LSO is available.

Question 20

LSO Specific Responsibilities

Hazard Classification

Answer 20

The LSO shall ensure that all lasers and laser systems in the HCF have been labeled by the manufacturer to indicate the appropriate hazard classification in accordance with the federal regulations.

If the manufacturer does not label a laser or laser system, the LSO shall ensure that the product is properly classified and that the correct classification label is affixed.

Question 21

LSO Specific Responsibilities

Hazard Evaluation

Answer 21

The LSO shall ensure that a hazard evaluation of the laser treatment controlled areas (LTCA) has been performed prior to laser operation.

This shall include evaluation of the potential hazards of the laser as used in the LTCA using the hazard and safety guidance as provided by the HCLS manufacturer and by taking into consideration the laser use environment and people using the laser.

In some cases, the LSO may perform a hazard evaluation and determine the laser hazard.

Question 22

LSO Specific Responsibilities

Hazard Response

Answer 22

The LSO, or designee, shall immediately inform the user of imminent danger from a laser hazard.

Question 23

LSO Specific Responsibilities

Control Measures

Answer 23

The LSO shall …
1. ensure that control measures as prescribed by the HCLS manufacturer or as determined by the LSO are in effect
2. recommend or approve substitute or alternate control measures when the primary ones are not feasible or practical
3. periodically evaluate the effectiveness of the selected controls.

Question 24

LSO Specific Responsibilities

Procedure Approvals

Answer 24

The LSO shall establish and enforce Policies and Procedures (P&Ps) for HCLS use.

These P&Ps should include maintenance, service, and procedural checklists and any laser safety related items reflected in the HCF P&Ps used by operating personnel.

Question 25

LSO Specific Responsibilities Protective Equipment

Answer 25

The LSO shall ensure that appropriate protective equipment is … 1. available 2. in good working order 3. is used correctly

Question 26

LSO Specific Responsibilities Signs and Labels

Answer 26

The LSO shall ensure that the wording on area signs and equipment labels are in accordance with ANSI Z136.3, section 4.7.

Question 27

LSO Specific Responsibilities Facilities and Equipment

Answer 27

The LSO shall approve the HCLS installation and equipment prior to use to ensure that it is consistent with the manufacturer’s safety recommendations and labeling contained in the user’s manual. Modifications of existing facilities or HCLS equipment shall be reviewed by the LSO. Modifications to the equipment shall comply with FDA regulations. A hazard evaluation of modified equipment shall be prepared, and shall be retained on file by the LSO. The LSO shall ensure that qualified personnel carry out periodic maintenance and service, and that records of this maintenance and service are maintained.

Question 28

LSO Specific Responsibilities Training

Answer 28

The LSO shall ensure that appropriate laser safety education and training is provided to all laser users including providers, clinicians, staff, technicians, students, and other health care personnel (HCP). The LSO shall ensure maintenance of records of laser safety education and training of those HCP as specified in ANSI Z136.3, section 5.

Question 29

LSO Specific Responsibilities Records

Answer 29

The LSO shall ensure that the necessary records required by applicable government regulations are maintained. Other records documenting the maintenance of the safety program, such as training records, audits, and standard operating procedure (SOP) approvals, shall be maintained.

Question 30

Location Types Unrestricted location

Answer 30

Access to an open beam is unrestricted. Examples include home and premises open to the public including offices and spas.

Question 31

Location Types Restricted location

Answer 31

Access to an open beam is not accessible to the public. Examples include secured areas within hospitals, such as operating room areas that are not open to the public and entry is secured by physical means.

Question 32

Location Types Controlled location

Answer 32

Access to any area where open beams are in use is controlled and entry is limited to authorized persons who have received adequate training in laser safety and proper use of the system.

Question 33

Stepwise procedure for determining a laser use environment

Answer 33

1. Determine the hazard class from the devise warning-label (device certification-label) 2. Determine the type of location. Type type of location will determine the degree of control measures required for each of the hazard classifications or access levels. 3. Determine and apply the relevant control measures required for the appropriate hazard level

Question 34

When considering a third party laser, what things shall the LSO verify are in the terms of agreement between the third party provider and the HCF? ANSI Z136.3, Section 1.4.2

Answer 34

1. Credentials. The credentials of the third party laser operators meet the facility’s policy. 2. Equipment. The HCF has received written validation of the maintenance, service, cleaning, and condition of the equipment. 3. Documentation. Data and elements of documentation collected by the third party are appropriate, meet the HCF policy, and can be verified by facility HCP. 4. Training. All HCP expected to be in the room with the third party laser have had adequate safety control training on the laser and accessory equipment in order to ensure a laser safe environment for all personnel and the patient during the device operation. 5. Assessment. Assessment should be performed through a thorough intake procedure, exceeding biomedical testing for electrical leakage, and include the condition of the HCLS and all delivery systems and accessory devices to be used, credentials of the technician, credentials of the provider, inventory of accessories (e.g., fibers, filters), documentation forms, and staffing requirements and assignments for personnel to be present in the room.