Recognized standard
10535 Second edition 2006-12-15
FDA recognition 6-253 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-253 |
|---|---|
| Designation | 10535 Second edition 2006-12-15 |
| Title | Hoists for the transfer of disabled persons - Requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | ISO 10535:2006 specifies requirements and test methods only for hoists and body-support units intended for the transfer of disabled persons as classified in ISO 9999:2002: - 12 36 03 Mobile hoists with sling seats - 12 36 04 Standing mobile hoists - 12 36 06 Mobile hoists with solid seats - 12 36 09… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: