Compliance inSight Consulting Inc.
, Compliance inSight Consulting Inc.
Cut­ting laser in action

Lasers are arguably one of the great­est inven­tions of the 20th cen­tu­ry. Once described as “a solu­tion in search of a prob­lem”, lasers are used in every aspect of life today, from sig­nal­ing, telecom­mu­ni­ca­tions and range find­ing, to sur­vey­ing, surgery and test­ing. Lasers come from picow­att to megawatt sizes and in infrared (IR), vis­i­ble, and ultra­vi­o­let (UV) varieties.

Whether you are inte­grat­ing lasers in equip­ment, build­ing lasers from scratch, con­duct­ing research or using them in your dai­ly oper­a­tions, you need to be aware of the haz­ards spe­cif­ic to your laser and application.

REGULATIONS

There are a num­ber of key reg­u­la­tions and stan­dards in force today. In Cana­da, the gen­er­al machin­ery safe­ty reg­u­la­tions in each province require that employ­ers pro­tect work­ers from haz­ards cre­at­ed by the machines and process­es that they use. Fed­er­al reg­u­la­tions place sim­i­lar require­ments on Fed­er­al­ly reg­u­lat­ed busi­ness­es as well. Lasers are reg­u­lat­ed under the Radi­a­tion Emit­ting Devices Act and the Cana­da Occu­pa­tion­al Health and Safe­ty Reg­u­la­tions. Lasers must be report­ed to the Con­sumer and Clin­i­cal Radi­a­tion Pro­tec­tion Bureau.

In the USA, the FDA reg­u­lates lasers through the Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH). Lasers and laser prod­ucts sold in the USA must be reg­is­tered with the CDRH and must meet the OSHA reg­u­la­tions for laser safe­ty. There are dif­fer­ent require­ments for med­ical and non-med­ical lasers.

In the EU, lasers are cov­ered under a num­ber of direc­tives, includ­ing 98/37/EC Machin­ery and the new edi­tion of the same direc­tive, 2006/42/EC , the Low Volt­age Direc­tive 2006/95/EC, and the EMC Direc­tive, 2004/108/EC.

STANDARDS

Canada

In Cana­da, the gen­er­al stan­dard for laser safe­ty is CAN/CSA E60825‑1. For health­care appli­ca­tions, the stan­dard is CSA Z386 where the laser is used in a health­care facil­i­ty (i.e. a sur­gi­cal laser), and is CAN/CSA-C22.2 NO. 60601–2‑22–01 for med­ical equip­ment appli­ca­tions. There are addi­tion­al stan­dards that per­tain to the elec­tri­cal shock and fire safe­ty of these prod­ucts as well.

USA

In the USA, the gen­er­al stan­dard for laser safe­ty is ANSI Z136.1. There are a num­ber of addi­tion­al parts of ANSI Z136 that may also apply to your appli­ca­tion. This stan­dard is being replaced by IEC 60825–1 as ANSI har­mo­nized with the Inter­na­tion­al Community.

In addi­tion, NFPA 115 deals with fire pro­tec­tion in lasers and laser instal­la­tions. The CDRH also pub­lish­es a laser stan­dard, 21 CFR 1040.10. Lasers intend­ed to be mar­ket­ed in the USA must meet the CDRH require­ments and be reg­is­tered with the CDRH before they can can be marketed.

For indus­tri­al appli­ca­tions, ANSI B11.21 applies to machin­ery incor­po­rat­ing lasers.

EU

In the EU, the pri­ma­ry laser safe­ty stan­dard is EN IEC 60825–1. In addi­tion, the fol­low­ing stan­dards may be applic­a­ble to your application:

  • EN ISO 11145:2006 Optics and pho­ton­ics — Lasers and laser-relat­ed equip­ment — Vocab­u­lary and sym­bols (ISO 11145:2006)
  • EN ISO 11252:2004 Lasers and laser-relat­ed equip­ment — Laser device — Min­i­mum require­ments for doc­u­men­ta­tion (ISO 11252:2004)
  • EN ISO 11553–1:2005 Safe­ty of machin­ery — Laser pro­cess­ing machines — Part 1: Gen­er­al safe­ty require­ments (ISO 11553–1:2005)
  • EN ISO 11553–2:2007 Safe­ty of machin­ery — Laser pro­cess­ing machines — Part 2: Safe­ty require­ments for hand-held laser pro­cess­ing devices (ISO 11553–2:2007)
  • EN ISO 11554:2006 Optics and pho­ton­ics — Lasers and laser-relat­ed equip­ment — Test meth­ods for laser beam pow­er, ener­gy and tem­po­ral char­ac­ter­is­tics (ISO 11554:2006)
  • EN 12254:1998 + A2:2008 Screens for laser work­ing places — Safe­ty require­ments and testing