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 ‘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

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

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

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

HIGHLIGHTS OF REVISIONS

•Class designations1, 1M, 2, 2M, 3R, 3B, 4

•Update emission limits–Short emission durations 10-13 s.–Photochemical vs. thermal limits

•Human access criteria

HIGHLIGHTS OF REVISIONS (Cont.)

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

requirement

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.

FUTURE TASKS

Agency clearances OCC OMB FDA

Impact analyses Rollout

CDRH Staff training Revision of guidance documents, report guides Field training Industry education

TEPRSSC INPUTS• Agreement w/reproposal• Technical comments• What if IEC FDIS not approved

– Modify reproposal– Continue w/reproposal