ANSI Z80.38:2017 pdf download.Ophthalmics一Light Hazard from Operation Microscopes Used in Ocular Surgery.
ANSI Z80.38 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery.
NOTE — General requirements for operation microscopes and test methods for these requirements are specified in ISO
10936-1.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this American National Standard. All standards are subject to revision, and parties to agreements based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
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.
ANSI Z80.36, Light hazard protection for ophthalmic instruments
ISO 10936-1, Optics and optical instruments – Operation microscopes – Part 1: Requirements and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfill the requirements of 5.2 in ANSI Z80.36
3.2
Group 2 instrument
ophthalmic instrument for which a potential light hazard exists and that does not fulfill the requirements of
5.2 in ANSI Z80.36
3.3
retinal protection device
mechanism placed in the path of illumination to increase the time to reach the recommended maximum retinal exposure limit
4 Requirements for optical radiation hazard
4.1 General
Operation microscopes shall comply with the light hazard protection requirements given in ANSI Z80.36.
4.2 Determination of classification group
The operation microscopes shall be classified as Group I or Group 2 instruments as defined in clause 4 in
ANSI Z80.36. The test methods given in clause 5 in ISO 10936-1 shall be used to make this determination.
4.3 Requirements for Group 1 instruments
4.3.1 General
The operation microscope shall be tested in accordance with 5.2 in ANSI Z80.36 to determine if it is a Group I instrument. If the operation microscope does not fulfill the requirements of 5.2 in ANSI Z80.36 for any limits therein specified, then for those limits the operation microscope is a Group 2 instrument.
4.3.2 Emission limits
The operation microscope shall be tested to assess its compliance with the requirements of 5.4.1 in ANSI Z80.36. For those limits for which the operation microscope fulfills the requirements of 5.4.1, the operation microscope is a Group 1 instrument, and there are no further requirements.
4.4 Requirements for Group 2 instruments
4.4.1 General
For radiation limits for which the operation microscope is found to be a Group 2 (see 4.3.1), the requirement of 5.3 in ANSI Z80.36 shall apply. Compliance with 5.3 in ANSI Z80.36 shall be verified using test methods referenced in clause 5.
4.4.2 Emission limits and guideline values
For those limits for which the operation microscope does not comply with the requirements of 5.4.1 in ANSI Z80.36, it shall comply with the requirements of 5.4.2 and 5.4.3 in ANSI Z80.36.ANSI Z80.38 pdf download.