Requirements from Regulations and Standards
498
FQ2 User’s Manual
12-7 Requirements from Regulations and Standards
Summary of Requirements to Manufactures
For Europe
EN 60825-1 “Safety of Laser Products, Equipment Classification, Requirements and User’s Guide”
Summary of Manufacturer’s Requirements
Note:1.This table is intended to provide a convenient summary of requirements. See text of this standard for complete
requirements.
2.For the safety medical laser products, IEC 60601-2-22 applies.
3.AEL: Accessible Emission Limit
Requirements
subclause
Classification
Class 1 Class 1M Class 2 Class 2M Class 3R Class 3B Class 4
Description of
hazard class
Safe under
reasonably
foreseeable
conditions
As for Class
1 except may
be hazardous
if user
employs
optics
Low power;
eye protec-
tion normally
afforded by
aversion
responses
As for Class
2 except may
be more haz-
ardous if user
employs
optics
Direct intra-
beam view-
ing may be
hazardous
Direct intra-
beam view-
ing normally
hazardous
High power;
diffuse reflec-
tions may be
hazardous
Protective housing Required for each laser product; limits access necessary for performance of functions of the
products
Safety interlock in pro-
tective housing
Designed to prevent removal of the panel until accessible
emission values are below that for Class 3R
Designed to prevent removal of the panel
until accessible emission values are below
that for Class 3B
Remote control Not required Permits easy addition of
external interlock in laser
installation
Key control Not required Laser inoperative when key
is removed
Emission warning
device
Not required Give audible or visible warning when laser is
switched on or if capacitor bank of pulsed
laser is being charged. For Class 3R only,
applies invisible radiation is emitted
Attenuator Not required Give means beside the On/
Off switch to temporarily
block beam
Location controls Not required Controls so located that there is no danger of
exposure to AEL above Classes 1 or 2 when
adjustments are made
Viewing optics Not required Emission from all viewing systems must be below Class 1M AEL
Scanning Scan failure shall not cause product to exceed its classification
Class label Required wording Figures A required wording
Aperture label Not required Specified wording required
Service entry label Required as appropriate to the class of accessible radiation
Override interlock label Required under certain conditions as appropriate to the class of laser used
Wavelength range label Required for certain wavelength ranges
LED label Make required word substitutions for LED products
User information Operation manuals must contain instructions for safe use. Additional requirement apply for Class 1M and
Class 2M
Purchasing and ser-
vice information
Promotion brochures must specify product classification; service manuals must contain safety information
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