ISO 10109-6:2005

INTERNATIONAL ISO
STANDARD 10109-6
Second edition
2005-11-15

Optics and photonics — Environmental
requirements —
Part 6:
Test requirements for medical optical
instruments
Optique et photonique — Exigences environnementales —
Partie 6: Exigences d'essai pour les instruments optiques médicaux



Reference number
ISO 10109-6:2005(E)
©
ISO 2005

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ISO 10109-6:2005(E)
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ISO 10109-6:2005(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
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International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 10109-6 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 1,
Fundamental standards.
This second edition cancels and replaces the first edition (ISO 10109-6:1994), which has been technically
revised.
ISO 10109 consists of the following parts, under the general title Optics and photonics — Environmental
requirements:
— Part 1: General overview, terms and definitions, climatic zones and their parameters
— Part 4: Test requirements for telescopic systems
— Part 6: Test requirements for medical optical instruments
— Part 7: Test requirements for optical measuring instruments
— Part 8: Test requirements for extreme conditions of use
— Part 11: Optical instruments for outdoor conditions of use
— Part 12: Conditions of transport for optical instruments

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INTERNATIONAL STANDARD ISO 10109-6:2005(E)

Optics and photonics — Environmental requirements —
Part 6:
Test requirements for medical optical instruments
1 Scope
This part of ISO 10109 is applicable to optical instruments and instruments with optical components in the field
of medicine.
It specifies requirements to be met with regard to the resistance of the optical, mechanical, chemical and
electrical properties or performance data of instruments to environmental influences and hence determines
geographical and technical areas of application. Environmental test methods, as specified in ISO 9022 (all
parts), are assigned to the various areas of application for the purpose of ascertaining the suitability of the
instruments in their respective area of application.
This part of ISO 10109 is the basis for the specification of environmental requirements and environmental
tests in instrument standards. If necessary, these requirements and tests can be amended in the instrument
standards.
This part of ISO 10109 does not deal with the requirements to be met by the packaging of the instrument
during transport from the manufacturer to the user.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 9022-1:1994, Optics and optical instruments — Environmental test methods — Part 1: Definitions, extent
of testing
ISO 9022-2:2002, Optics and optical instruments — Environmental test methods — Part 2: Cold, heat and
humidity
ISO 9022-3:1998, Optics and optical instruments — Environmental test methods — Part 3: Mechanical stress
ISO 9022-11:1994, Optics and optical instruments — Environmental test methods — Part 11: Mould growth
ISO 9022-12:1994, Optics and optical instruments — Environmental test methods — Part 12: Contamination
ISO 9022-13:1998, Optics and optical instruments — Environmental test methods — Part 13: Combined
shock, bump or free fall and dry heat or cold
ISO 10109-1:2005, Optics and photonics — Environmental requirements — Part 1: General overview, terms
and definitions, climatic zones and their parameters
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ISO 10109-6:2005(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9022-1 and ISO 10109-1 apply.
4 Subdivision of medical optical instruments
Medical optical instruments are subdivided into instrument types with the type numbers given in Table 1.
NOTE Previously, medical optical instruments were designated as instrument group number 05, however, the use of
group numbers is no longer recommended.
Table 1 — Subdivision of medical optical instruments
Type number Instrument type
01 Field instruments: Instruments which are used in, for example, rescue helicopters or tents. They are
generally protected against direct weather influences such as rain, snow or solar radiation.
02 Instruments in weather-protected locations: Locations in which heating or cooling are to be used to
ensure that the required conditions (e
...