| ISO 10936-2 Second edition 2010-01-15 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
| Recognition Date | 2011-08-02 |
| Recognition List | 027 |
| Recognition Number | 10-66 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Dexiu Shi FDA/OMPT/CDRH/ODE/DOED/DSDB/ 301-796-6470 dexiu.shi@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.4690 | Photocoagulator And Accessories | Class 2 | HQB |
| §886.4670 | Laser, System, Phacolysis | Class 2 | MXO |
| §886.4392 | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | Class 2 | LXS |
| §886.4390 | Laser, Ophthalmic | Class 2 | HQF |
| §886.4150 | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | HQE |
| §886.3600 | Intraocular Lens | Class 3 | HQL |
| §886.3600 | Lens, Multifocal Intraocular | Class 3 | MFK |
| Unclassified | Excimer Laser System | Class 3 | LZS |
| Unclassified | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | Class 3 | LOI |
| There is no relevant guidance developed at this time. |