Recognized standard
9626 Second edition 2016-08-01
FDA recognition 6-380 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-380 |
|---|---|
| Designation | 9626 Second edition 2016-08-01 |
| Title | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 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 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: