AMENDMENTS TO CDRH LASER STANDARD

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AMENDMENTS TOCDRH LASER STANDARD
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TEPRSSC 99 Revisited. Presentation Summary
. Discussion Summary
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TPRSSC 99 Presentation

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

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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

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STATUS OF THEIEC AMENDMENTS

• CDV approved 151 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

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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

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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

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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

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HIGHLIGHTS OF REVISIONS (Cont.)

• Classification measurements
• Service information
• Class 1 Limit for novelty/toy laser products
• Clarify military exemption requirement

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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.

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FUTURE TASKS

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

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TEPRSSC INPUTS

• Agreement w/reproposal
• Technical comments
• What if IEC FDIS not approved
• Modify reproposal
• Continue w/reproposal