Recognized standard
10535 Third edition 2021-10
FDA recognition 6-486 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-486 |
|---|---|
| Designation | 10535 Third edition 2021-10 |
| Title | Assistive products - 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 | May 29, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | ISO 10535:2021 specifies requirements and test methods only for hoists and body-support units intended for the transfer of persons with disabilities. The document applies to the following products classified in ISO 9999:2022: - 12 36 03 Mobile hoists for transferring a person in sitting position… |
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: