IEC TR 60825-8:1999

Safety of laser products - Part 8: Guidelines for the safe use of medical laser equipment

Serves as a guide intended to give information to the employer and the user on the safe use of lasers and laser equipment classified as class 3B or class 4, for diagnostic and therapeutic applications in healthcare facilities. Explains the control measures recommended for the safety of patients, staff, maintenance personnel, and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.

General Information

• Status: Published
• Publication Date: 24-Nov-1999
• ICS: 11.040.99 - Other medical equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: WG 4 - TC 76/WG 4
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 08-Dec-2006

Relations

• Revised: IEC TR 60825-8:2006 - Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans
• Effective Date: 05-Sep-2023

Standards Content (Sample)

TECHNICAL IEC
REPORT
TR 60825-8
First edition
1999-11
Safety of laser products –
Part 8:
Guidelines for the safe use
of medical laser equipment
Sécurité des appareils à laser –
Partie 8:
Lignes directrices pour la sécurité d'utilisation
des appareils à laser médicaux

Reference number
IEC/TR 60825-8:1999(E)
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

TECHNICAL IEC
REPORT
TR 60825-8
First edition
1999-11
Safety of laser products –
Part 8:
Guidelines for the safe use
of medical laser equipment
Sécurité des appareils à laser –
Partie 8:
Lignes directrices pour la sécurité d'utilisation
des appareils à laser médicaux

 IEC 1999  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
W
International Electrotechnical Commission
For price, see current catalogue

– 2 – TR 60825-8 © IEC:1999(E)

CONTENTS
Page
FOREWORD . 3

INTRODUCTION .5

Clause
1 General. 6

1.1 Scope and object . 6
1.2 Reference documents . 6
1.3 Terminology and definitions. 7
2 Hazards, goals and control measures . 9
2.1 Eye hazards . 9
2.2 Skin hazards . 11
2.3 Fire and burn hazards . 11
2.4 Fumes, plumes and vapours. 13
2.5 Collateral hazards . 13
3 Administrative procedures . 14
3.1 Laser safety officer (LSO) . 14
3.2 Medical supervision (ophthalmic surveillance) . 15
3.3 INCIDENT and ACCIDENT reporting . 16
3.4 Maintenance and inspection . 17
4 Training recommendations . 17
5 Laser environment . 17
5.1 The laser controlled area. 17
5.2 Windows . 18
5.3 Walls . 18
5.4 Door switches and locks. 18
5.5 Fire protection. 18
5.6 Fume extraction . 18
Annex A Biological effects, hazards, laser equipment technology . 19
Annex B Window shielding . 27

Annex C Checklist for laser installation . 29
Annex D Laser safety training . 32
Annex E Inspection schedule. 33
Annex F Safety issues in laser applications. 37

TR 60825-8 © IEC:1999(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
SAFETY OF LASER PRODUCTS –
Part 8: Guidelines for the safe use of medical laser equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this technical report may be the subject of
patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
Technical reports do not necessarily have to be reviewed until the data they provide are
considered to be no longer valid or useful by the maintenance team.

IEC 60825-8, which is a technical report, has been prepared by IEC technical committee 76:
Optical radiation safety and laser equipment.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
76/180/CDV 76/194/RVC
Full information on the voting for the approval of this technical report can be found in the report
on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.

– 4 – TR 60825-8 © IEC:1999(E)

This document which is purely informative is not to be regarded as an International Standard.

Terms indicated in small capitals are defined in 1.3.

A bilingual version of this technical report may be issued at a later date.

TR 60825-8 © IEC:1999(E) – 5 –

INTRODUCTION
Lasers emit visible and/or invisible optical radiation. In some cases, this radiation is a parallel

beam with almost no divergence. This means that the inherently high IRRADIANCE (power per

unit of area irradiated) of the laser may be maintained over considerable distances. Because of

this, the beam may be focused to a very small area, which may be hazardous to the eye.

Annex A includes descriptions of laser systems and some medical applications.

Lasers may present hazards to patients and staff. Serious risks of injury, in particular to the

eye, and/or undesired effects can result from lack of protective measures, the use of faulty

laser equipment, misdirected beams or inappropriate laser control settings.

This guide is intended to give direction as to how aspects of laser safety may be incorporated
into medical laser practice. Its publication as a technical report indicates that it is not intended
to take precedence over existing or proposed national guidance. However, where none exists,
this guide should prove helpful.
Although the LASER USER has direct responsibility for safety during treatment, the employer
bears the responsibility for the setting up of a framework for the safe use of the system. This
guide strongly advocates the appointment of a LASER SAFETY OFFICER to provide expert advice
to the employer and all personnel concerned with the laser operation. This guide emphasizes
the need for appropriate laser safety training for all staff involved in providing practical
guidance on installation and maintenance.

– 6 – TR 60825-8 © IEC:1999(E)

SAFETY OF LASER PRODUCTS –
Part 8: Guidelines for the safe use of medical laser equipment

1 General
1.1 Scope and object
This technical report serves as a guide intended to give information to the employer and the
USER on the safe use of lasers and laser equipment classified as class 3B or class 4, for
diagnostic and therapeutic applications in healthcare facilities. However, particular care should
be taken in the use of class 2 and class 3A lasers where the patient’s normal aversion
response is compromised or absent.
This report explains the control measures recommended for the safety of patients, staff,
maintenance personnel and others. Engineering controls which form part of the laser
equipment or the installation are also briefly described to provide an understanding of the
general principles of protection. However, detailed specifications of laser equipment and
installation controls are not included in this report, such requirements being separately
specified in other standards, e.g. see 1.2.
The subject areas covered in this guide include
– BEAM DELIVERY SYSTEMS;
– biological effects of laser radiation;
– reporting of ACCIDENTS and dangerous situations;
– checklists.
The object of this report is to enhance the protection of persons from laser radiation and other
associated hazards by providing guidance on how to establish safety procedures, precautions
and user control measures.
1.2 Reference documents
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
IEC 60601-1-1:1992, Medical electrical equipment – Part 1: General requirements for safety –
1. Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-2-22:1995, Medical electrical equipment – Part 2: Particular requirements for the
safety of diagnostic and therapeutic laser equipment
IEC 60825-1:1993, Safety of laser products – Part 1: Equipment classification, requirements
and user's guide
ISO/TR 11991:1995, Guidance on airway management during laser surgery of upper airway

TR 60825-8 © IEC:1999(E) – 7 –

1.3 Terminology and definitions

For the purpose of this technical report, the following definitions apply. Reference is also made,

as indicated, to IEC 60825-1 and IEC 60601-2-22.

1.3.1
accident
INCIDENT wh
...