ISO 12609-2:2013
(Main)Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use
ISO 12609-2:2013 gives guidance and information to users, manufacturers, suppliers, and safety advisors on the selection and use of eye protectors for intense light source (ILS) equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation. ISO 12609-2:2013 provides guidance on selection of an eye protector expected to cope with the majority of applications and a more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment.
Équipements ophtalmiques de protection contre les sources lumineuses intenses utilisées sur les animaux et les humains pour des applications médicales et cosmétiques — Partie 2: Directives d'utilisation
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 12609-2
First edition
2013-07-15
Eyewear for protection against intense
light sources used on humans and
animals for cosmetic and medical
applications —
Part 2:
Guidance for use
Équipements ophtalmiques de protection contre les sources
lumineuses intenses utilisées sur les animaux et les humains pour des
applications médicales et cosmétiques —
Partie 2: Directives d’utilisation
Reference number
ISO 12609-2:2013(E)
©
ISO 2013
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ISO 12609-2:2013(E)
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ii © ISO 2013 – All rights reserved
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ISO 12609-2:2013(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Terms and definitions . 1
3 Optical radiation hazards . 2
3.1 Risk assessment . 2
3.2 Control measures . 2
4 Eye protection . 3
4.1 Protective eyewear . 3
4.2 Filter protection factor (FPF) . 3
4.3 Luminous transmittance and colour perception . 4
5 User comfort and secondary safety issues . 4
5.1 Peripheral leakage . 4
5.2 Secondary reflections from eyewear frame and filters . 4
5.3 Quality of filters and clarity of vision . 4
5.4 Exposure to bright flashes below ELVs . 4
5.5 Overheating of eyewear . 5
5.6 Additional considerations for auto darkening filters . 5
Annex A (informative) Ocular exposure to optical radiation . 6
Annex B (informative) Retinal thermal hazard — Assessment flowchart . 7
Annex C (informative) Retinal thermal hazard — Example calculation . 8
Annex D (informative) Protective eyewear for the patient/client .12
Annex E (informative) Protective eyewear for the operator .13
Annex F (informative) Filter protection factor .14
Annex G (informative) Luminous transmittance .16
Annex H (informative) Colour perception of ILS protective eyewear — Example .17
Bibliography .18
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ISO 12609-2:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
The committee responsible for this document is ISO/TC 94, Personal safety – Protective clothing and
equipment, Subcommittee SC 6, Eye and face protection.
ISO 12609 consists of the following parts, under the general title Eyewear for protection against intense
light sources used on humans and animals for cosmetic and medical applications:
— Part 1: Specification for products
— Part 2: Guidance for use
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INTERNATIONAL STANDARD ISO 12609-2:2013(E)
Eyewear for protection against intense light sources
used on humans and animals for cosmetic and medical
applications —
Part 2:
Guidance for use
1 Scope
This International Standard gives guidance and information to users, manufacturers, suppliers, and
safety advisors on the selection and use of eye protectors for intense light source (ILS) equipment used
on humans and animals for cosmetic and medical applications against excessive exposure to optical
radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.
This International Standard provides guidance on selection of an eye protector expected to cope with
the majority of applications and a more rigorous procedure for determining appropriate eye protection
against spectral outputs from ILS equipment.
This International Standard is not applicable to eye protectors for use with tanning equipment,
ophthalmic instruments, or other medical/cosmetic devices, the safety issues of which are addressed
through other European and International Standards.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
attenuation
decrease in the irradiance or radiant exposure as optical radiation passes through an absorbing or
scattering medium
2.2
exposure limit values
ELVs
level of exposure to the eye or skin that is not expected to result in adverse biological effects
2.3
intense light source
ILS
device incorporating one or more non-laser sources of optical radiation of the wavelength range 250 nm
to 3 000 nm and intended for creating biological effects in humans and animals
Note 1 to entry: It can operate in continuous or pulsed regime.
2.4
ocular hazard distance
OHD
distance at which the beam irradiance, radiance, or radiant exposure equals the appropriate ocular ELVs
2.5
pulse duration
time increment measured between the half peak (50 %) of power points at the leading and trailing
edges of a pulse
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ISO 12609-2:2013(E)
2.6
pulse separation
time between the end of one pulse and the onset of the following pulse, measured at the 50 % trailing
and leading edges
2.7
skin hazard distance
distance at which the beam irradiance or radiant exposure equals the appropriate skin ELVs
3 Optical radiation hazards
3.1 Risk assessment
3.1.1 The eye is at risk of injury from optical radiation in excess of the exposure limit values (ELVs)
(see Annex A). A comparison of the predicted or measured radiation exposure with the applicable ELVs
allows an assessment of a personal workplace exposure to optical radiation.
3.1.2 The risk assessment should include the following.
a) Determine the ELVs for exposure duration, type of hazard, and emitting device configuration.
b) Determine the likely exposure level from the ILS taking account of the exposure scenario, e.g.
expected use or foreseeable fault conditions.
c) Compare the likely exposure levels with the ELVs.
3.1.3 If other measures are insufficient or inadequate to control the risk of eye exposure in excess of
any applicable ELVs, eye protection should be worn. The appropriate F-#, B-#, and/or filter protection
factor should be determined at a distance of 200 mm from the ILS. If such eye protection is not available,
a calculation using measured spectrally weighted radiance or irradiance has to be carried out in order
to verify the suitability of a specific eyewear for a specific ILS source.
NOTE Personnel who might be at risk include the patient/client, ILS equipment operator, assisting staff, and
others.
3.1.4 See Annex B for a retinal thermal hazard assessment and Annex C for a worked example calculation.
3.2 Control measures
3.2.1 Any person who is present within the ocular and skin hazard distance should be protected
against eye or skin exposure to optical radiation above any applicable ELVs.
3.2.2 The extent of the skin and ocular hazard distance might vary according to the type of ILS
equipment used and the optical properties of the output optics attachments.
3.2.3 Exposure to optical radiation should be reduced, as far as reasonably practicable, by means
of physical safeguards, such as engineering controls. Personal protection should only be used when
engineering and administrative controls are impracticable or incomplete, in accordance with Figure 1.
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ISO 12609-2:2013(E)
Hierarchy of control measures
Containment
Enclosures
Engineering controls
Interlocks
Housing
Screens
Assessment of hazards
Local rules and procedures
Contingency plans
Supervision
Administrative controls
Training
Access control
Personal protective equipment
Figure 1 — Hierarchy of control measures
4 Eye protection
4.1 Protective eyewear
4.1.1 Reduction of unintended exposure should be included in the design specifications of the ILS
equipment. Exposure to optical radiation should be reduced, as far as reasonably practicable, by means
of physical safeguards, such as engineering controls.
4.1.2 When the treatment region is close to the eye, the patient’s or client’s protective eyewear should
be selected carefully, as there will be a significant risk of exposure in excess of the ELVs. Consideration
should also be given to the good fit of safety eyewear to prevent penetration of optical radiation from
around the frame.
4.1.3 Different types of eye protection might be required for patients/clients, ILS equipment operators,
and supporting personnel.
4.1.4 An unambiguous and robust method of marking the ILS protective eyewear should be employed
to ensure that there is a clear link to the particular ILS equipment device for which it has been specified,
and to facilitate this, a simplified classification scheme has been introduced.
4.1.5 A checklist to help select protective eyewear for the patient/client is given in Annex D.
4.1.6 A checklist to help select protective eyewear for the operator is given in Annex E.
4.2 Filter protection factor (FPF)
4.2.1 ELVs should be used to determine the required attenuation level of ILS protective filters because
they refer to effective, i.e. spectrally weighted, values.
4.2.2 Optical density or shade numbers should not be used for the characterization of ILS protective
filters as they do not take into account the difference in the effect of different wavelengths on the eye.
4.2.3 FPF is a factor by which the protective filter attenuates the weighted ocular exposure. If the risk
assessment demonstrates that ocular exposure limits are exceeded, the FPF of the protective eyewear
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ISO 12609-2:2013(E)
should be adequate to ensure the exposure limit is not exceeded (see Annex F). This excess factor is likely
to be different for a patient/client and operator; therefore, the FPF of protective eyewear for patient and
operator would be different.
4.3 Luminous transmittance and colour perception
4.3.1 The luminous transmittance and the colour of the environment as seen through ILS protective
filters (perceived colour) are important characteristics of protective eyewear which enable the operator
to perform treatment without compromising non-optical radiation safety (see Annex G and Annex H).
4.3.2 Perceived colour depends on the spectral characteristics of the protective filter and illumination
source. Thus, treatment might be performed under general light conditions (white light) or operating
procedures might require an operator to observe the patient/client and control the equipment illuminated
with radiation from ILS equipment.
In these two cases, the colour of the environment (for example, equipment controls and blood) might
appear different when seen through the same protective eyewear.
4.3.3 Colour is described as a (x, y) Commission Internationale de L’Eclairage (CIE) colour coordinate
and might be presented in a CIE chromaticity chart (see Annex H). The (x, y) CIE coordinates take into
account spectral characteristics of the filter and illumination source.
5 User comfort and secondary safety issues
5.1 Peripheral leakage
Consideration should be given to the good fit of safety eyewear to prevent penetration of optical radiation
from around the frame. This should be tested using a bright light prior to each use.
NOTE A patient’s aversion response might be altered due to anaesthesia, sedation, or other drugs.
5.2 Secondary reflections from eyewear frame and filters
Secondary reflections from frames or filters of protective eyewear might increase the risk of uncontrolled
exposure of the user or others; therefore, mirror-finish or high gloss filters and frames should not be used.
5.3 Quality of filters and clarity of vision
5.3.1 Quality of filters of protective eyewear and clarity of vision should not limit the intended use of
the ILS equipment; therefore, these characteristics are essential for an operator and unimportant for a
patient/client. Patient/client protective eyewear may be opaque.
5.3.2 Filters of operator’s eyewear should be free from any material or surface defects which are
likely to impair the intended use, such as bubbles, scratches, inclusions, dull spots, scoring, excessive
colouration, or other defects.
5.4 Exposure to bright flashes below ELVs
5.4.1 For lower exposure levels (below ELVs), visual effects due to the temporary visual impairment
might pose secondary safety hazards. Transient visual effects include disability (dazzle or veiling) glare,
discomfort glare, startle (distraction), and after-images (flash blindness) (see Annex A).
5.4.2 Exposure to bright flashes cannot be corrected by the passive attenuation filters because passive
filters attenuate ambient and flash level simultaneously. To reduce this exposure, auto darkening
protective filters should be considered.
5.4.3 Precautions should be taken against secondary safety hazards resulting from a temporary
reduction in vision.
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