Recognized standard
11608-7 First edition 2016-08-01
FDA recognition 6-382 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-382 |
|---|---|
| Designation | 11608-7 First edition 2016-08-01 |
| Title | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Sep 21, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 11608-7:2016 specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans. It covers… |
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: