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AMENDMENTS TO CDRH LASER STANDARD

AMENDMENTS TO CDRH LASER STANDARD. TEPRSSC ‘99 Revisited . Presentation Summary . Discussion Summary. TPRSSC ‘99 Presentation. Motivations History Proposed CDRH Amendments (FR 3/24/99) Status of IEC 60825-1 Options for CDRH. TEPRSSC ‘99 Panel Discussion. Motion approved:

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AMENDMENTS TO CDRH LASER STANDARD

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  1. AMENDMENTS TOCDRH LASER STANDARD

  2. TEPRSSC ‘99 Revisited. Presentation Summary. Discussion Summary

  3. TPRSSC ‘99 Presentation • Motivations • History • Proposed CDRH Amendments (FR 3/24/99) • Status of IEC 60825-1 • Options for CDRH

  4. TEPRSSC ‘99Panel Discussion • Motion approved: • Wait for IEC votes • Proceed with all due haste • Other discussion: • CDRH taking the lead • Do not include LEDs • Reduce CDRH/IEC gap • NOT Discussed: • Vertical standard for toy/novelty lasers

  5. STATUS OF THEIEC AMENDMENTS • CDV approved 15:1 9/30/99 • TC76 Plenary voted (11/12/99) to distribute FDIS for vote in 04/00 • FDIS delivered to IEC CO 3/1/00 • IEC plans to distribute FDIS in June with voting to close in August • If approved, the amended IEC standard may be published in October, 2000

  6. TEPRSSC ‘00 Handout (Briefing Package) • Draft revised proposed amendments to the CDRH Standard • Revisions based on presumption of approval of the IEC FDIS • Revisions are still an incomplete draft

  7. WHY REPROPOSE? Significant changes since 1999 proposal • 1999 based on 1995 IEC Scheme • 1999 IEC CDV for 2000 Amendment • Hew Classification scheme • New measurement requirements • New AELs w/short pulse limits & photochemical vs thermal limits

  8. HIGHLIGHTS OF REVISIONS Class designations 1, 1M, 2, 2M, 3R, 3B, 4 Update emission limits Short emission durations 10-13 s. Photochemical vs. thermal limits Human access criteria

  9. HIGHLIGHTS OF REVISIONS (Cont.) Classification measurements Service information Class 1 Limit for novelty/toy laser products Clarify military exemption requirement

  10. PRESENT TASKS • Complete draft revised amendments for CDRH standard. • Rework IEC FDIS into CDRH format • Prepare preamble • Analysis of comments from 3/24/99 FR notice.

  11. FUTURE TASKS • Agency clearances • OCC • OMB • FDA • Impact analyses • Rollout • CDRH Staff training • Revision of guidance documents, report guides • Field training • Industry education

  12. TEPRSSC INPUTS • Agreement w/reproposal • Technical comments • What if IEC FDIS not approved • Modify reproposal • Continue w/reproposal

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