February 18, 2022 TPG

FAQ

DEFINITIONS

A Photon is an elementary particle- the quantum of the electromagnetic field including electromagnetic radiation including light and radiowaves. It has an invariant mass of 0 and moves at the speed of light in a vacuum.

Photonics is the study of the Photon like Electronics is the study of the Electron. The field of Photonics encompasses the source, transmission, detection, and analysis of the Photon. It includes Optics, Optical Physics, Optoelectronics, Fiberoptics, Detection, Spectroscopy (cross-over with Chemistry and Materials Science), etc..

US (21CFR1040)

IEC (EN60825)

ANSI Z136

MeaningTypical Applications
I1Safe; Hazardous laser source embedded in safe productLaser printers and CD players
—1MSafe except when used with magnifying opticsMicroscope illuminators
II2Low powerAlignment, distance, and quantity measurement
lla2MLow powerStore barcode scanner and laser pointers
IIIa3RMedium powerAnalytical instrumentation, scanners, and laser pointers
IIIb3BIntermediate powerAnalytical instrumentation
IV4High powerMaterials processing

A Laser Safety Program is specific to laser sources, and may be part of a larger Photonics Safety Program which covers sources other than lasers such as LEDs, high intensity white light sources, inspection lamps, and UV curing sources, and includes, transmission, detection, and analysis technologies.

A NHZ is a defined area within which laser/Photonics radiation is hazardous and above Class I/1. It may or may not have physical engineering controls which preclude entry.

An LCA is a contained area within which laser hazards are contained and has access controls to preclude entry.

An NHZ is a defined area of risk, within which someone must be protected against the prescribed radiation with the proper PPE and SOP, an LCA other is a defined area of control outside of which is perfectly safe. They are independent of each other- an LCA can be within an NHZ and an NHZ can be within and LCA.

Laser Safety is the study and applications of risk mitigation related to LASER technologies.

Photonics Safety is the study and application of risk mitigation to Photonics technologies and includes Laser, Fiberoptic, UV light source, and flashlamp safety sub-disciplines.

A Laser Safety Officer (or “LSO”) is someone who is charged with being the point of contact for laser-related activities at an organization which designs/develops, manufactures/repairs, and/or uses lasers and laser-based products and processes. Because The Photonics Group addresses the entire field of Photonics, and recognizes other potentially hazardous Photonics sources, we refer to the Laser Safety Officer as the Photonics Safety Officer. You can find a more complete list of LSO duties here.

A non-beam hazard (NBH) is exposure not related to a beam of Photons, but nonetheless includes associated risks. Examples of NBH include:

  • Electronic/electrical hazards such as supply/mains power, high-voltage stingers, and operating supplies

  • Thermal risks which exist from extreme temperatures when working with cryogenic materials at the low end and targets exposed to 2000°C and higher.

  • Exposure to materials which may be carcinogenic and/or lethal

  • Exceedingly high levels of RF

  • Sound or noises which may exceed pain and/or loss of hearing, exceeding OSHA standards.

  • Gaseous and vaporous elements

  • Mechanical hazards such as guards, rotating machinery, and robotics

REGULATIONS AND STANDARDS

Yes and no. in the US, laser components must be registered, and product reports must be filed for laser-based products as per 21CFR1040.10/.11, but there are no regulations for LEDs or fiber optics. Overseas, the IEC, requires lasers to comply with IEC EN60825 and LEDs to comply with IEC EN62471.

The following apply to both US and primarily EU countries:

  • 21CFR1040.10/.11 (regulation) for lasers and laser-based products in the US

  • ANSI Z136 (standard) for laser product and workplace management

  • IEC EN62471 (standard) for LEDs in the EU

Although OSHA has a guidance document page, OSHA, and most states, defer to the ANSI Z136 set of standards for workplace safety.

As electronic products, LEDs are regulated in the US by the FDA/CDRH, but are not subject to any performance standards or certification/reporting (self or otherwise).

STANDARD OPERATING PROCEDURES (SOP) and BEST PRACTICES

A non-beam hazard (NBH) is exposure not related to a beam of Photons, but nonetheless includes associated risks. Examples of NBH include:

  • Electronic/electrical hazards such as supply/mains power, high-voltage stingers, and operating supplies

  • Thermal risks which exist from extreme temperatures when working with cryogenic materials at the low end and targets exposed to 2000°C and higher.

  • Exposure to materials which may be carcinogenic and/or lethal

  • Exceedingly high levels of RF

  • Sound or noises which may exceed pain and/or loss of hearing, exceeding OSHA standards.

  • Gaseous and vaporous elements

  • Mechanical hazards such as guards, rotating machinery, and robotics

According to ANSI Z136.1-2014: “Training shall be provided to each LSO and employee routinely working with or potentially exposed to Class 3B or Class 4 laser radiation. Training should be provided to employees working with or potentially exposed to Class 1M, Class 2, Class 2M or Class 3R laser radiation”. Note- this applies to safety training. Training on laser-based equipment itself is always mandatory. From basic operators to maintenance and service personnel, some training is typically required- check with your supervisor or equipment manufacturer.

Depending upon:

  • disposition (sale/transfer, destruction, or mothball)

  • laser type

  • configuration

there are a number of issues you want to pay attention to including:

  • dumping/discharging stored energy

  • de-watering the system (from the head to re-circulation)

  • relaxing/de-loading preloaded mechanical systems

It is always best to refer to the documentation and/or contact the manufacturer for guidance

Although according to ANSI Z136.1-2014 “Any employee with an actual or suspected laser-induced injury should be evaluated by a medical professional as soon as possible after the exposure (usually within 48 hours).” We suggest employees who will be working around Class III/3 and higher class lasers and/or UV sources of any type, obtain an eye exam prior to starting position, upon incident exposure, and upon exiting position. Check with your supervisor, EHS/SIH, or HR for more information.

Typically no.

While a specific pair of eyewear might indeed cover more than 1 wavelength, be within the same OD, offer the same damage threshold, and VLT within an optical setup or lab, each lab might contain different or varied sources. PPE migration is one of the leading causes of Photonics-based incidents and accidents.

Most eyewear is not designed to be used intra-beam.

For instance, Polymer-based substrates, when hit with a high enough power or pulse energy to vaporize, will not afford protection and generate toxic polymer-based fumes.

Laser eyewear must be checked for scratches and cracks before donning. Scratches can become more serious if deep enough, and are the first locations to fail (crack)- Cracks are especially worrisome because a crack is like the Grand Canyon to a Photon- Especially because the eye will still be dilated due to wearing the eyewear. Do not don any PPE that is damaged in anyway.

Most of the time, if you get hit in the eye with a laser beam, you will know it.

  • A low power visible beam will cause you to finch and move your head away (“blink response” or “light aversion”).

  • An intermediate or UV laser beam pulse or irradiation might show itself as pain and itching (like getting sand or some irritant in the eye) as you may encounter Photokeratitis.

  • A high power beam (any wavelength) shot directly in the eye could destroy your eye at the speed of light.

Interlocks should be checked for condition and function as part of the production or PM cycle. Condition to ensure they are structurally capable of use- no broken or worn components and that the safety interlock is secured to product/process -Function to ensure they activate shutdown safely and reliably as prescribed in the manual.

According to ANSI Z136.1, 21CFR1040.10/.11 and IECEN60825 there are very specific locations and formats which need to be followed in order to be compliant to both product and workplace requirements with respect to labeling information, format, and location.

Management should establish the LSO position. Adding LSOs typically depends upo

  • number of lasers

  • number of facilities containing laser activity (and where they are located)

  • laser activity

  • number of employees working with or potentially exposed to lasers and laser radiation

DESIGN AND INTEGRATION

A defeatable interlock device is one which is designed, by the manufacturer, to be defeated. Examples of defeat elements can include a “pull to activate” feature, an “interrupt key”, or a coded magnet (in the case of proximity-type magnetically activated interlock switches). Jamming a foreign object, taping, clamping an interlock may “defeat” its operation, but if you have to do such things, the interlock switch is NOT defeatable as per the definition.

 

Specific type, application, and function are up to product designers, as long as it meets the regulations and standards. Non-defeatable (those interlocks designed not to be defeated) are typically used where there is a large and frequent potential for exposure such aas operator panels and doors. Defeatable interlocks (those that are designed to be defeated) are typically used where there is less frequent potential for exposure and where skilled and trained personnel gain access such as maintenance and service panels.

Perform a GAP analysis and execute the plan in order to for the product/process to become compliant and safe. Once the compliance and risk engineering is completed and the documentation reflects current status of the product/process, a product report needs to be filed with the FDA/CDRH- preferably before introduction into commerce.

Yes, the federal code states who must comply with the regulations:

“Modification of a certified product. The modification of a laser product, previously certified under 1010.2, by any person engaged in the business of manufacturing, assembling, or modifying laser products shall be construed as manufacturing under the act if the modification affects any aspect of the product’s performance or intended function(s) for which this section and 1040.11 have an applicable requirement. The manufacturer who performs such modification shall recertify and reidentify the product in accordance with the provisions of 1010.2. and 1010.3.”

PERSONAL PROTECTIVE EQUIPMENT (PPE)

Depending upon various factors including the type of:

source (LASERs, LED, high-pressure/low-pressure Sodium discharge, Mercury vapor (UV), fluorescent, flash lamp, etc..)

  • environment

  • application and use

  • user preferences

PPE could be as mild as a simple pair of googles or a full respiration suit.

Eyewear (googles and glasses)- Must be ANSI Z87.1-2015 rated and list wavelength, Optical Density (OD), Visible Light Transmittance (VLT), and damage threshold ratings appropriate for both the source employed and the environment in which they are used.

Skin cover (long sleeve shirts and pants)- for high-power and/or UV sources which may cause DNA/RNA and skin damage.

Inhalation (masks, shields, respirators)- Class IV/4 lasers when processing materials, may create fumes and vapors which can be very dangerous.

There are a number of quality suppliers you can locate either through a browser search, or through industry-specific sites which contain buyer guides:

Laser Focus

Photonics

Optics

RP Photonics

Make sure the vendor chose works with you to ensure a properly matched solution, not just selling stock.

LaserSafe PC

LaserSafe PC is extremely efficient and does not require extensive computing resources:

  • Windows-based machine running Vista or Windows 7 though 10
  • Pentium or Intel series processor
  • ≥ 4 Gb RAM
  • ≥ 100 Mb hard drive/storage
  • Any graphics card.

The Demo has all the functionality of the full version except it is limited to 966 nm and you cannot save output files.

LaserSafe PC calculates the necessary data in order to determine safe design, use, and classification. It does not create a product report, (which if created properly, is only a small part of what is required to satisfy 21CFR1040.10/.11, namely the support documentation including drawings, manuals, plans, schematics, etc..) If you need a product report created for a laser product, let us know– we have been filing for decades and would love to help.

LaserSafe PC does create the data which you will need to enter into an inventory tracking sheet and will have inventory database functionality.

OTHER-MISCELLANEOUS

Amazon and eBay know about the issue and are working to limit the pass through of such violating products.

Absolutely not. Most probably a product report has been filed with the FDA/CDRH (if one hasn’t, and there is no accession number, contact us immediately) and the product has undergone testing through a Nationally Recognized Test Laboratory (NRTL) with all the features in place- including, significantly- safety devices. If you modify or remove anything, especially interlocks, you’ve now changed the compliance and potentially the safety of the product. Better to contact the manufacturer first.

Call Now Button