ISO 10109-6:2005 PDF

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.

ISO 10109-6:2005 Referenced Document

ISO 10109-1:2005 Optics and photonics - Environmental requirements - Part 1: General overview, terms and definitions, climatic zones and their parameters
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 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

2005 ISO 10109-6:2005 Optics and photonics - Environmental requirements - Part 6: Test requirements for medical optical instruments
1994 ISO 10109-6:1994 Optics and optical instruments - Environmental requirements - Part 6: Test requirements for medical optical devices