CFR section
21 CFR 630.10(f)(4): General donor eligibility requirements
PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE · Subpart B-Donor Eligibility Requirements
Key facts
| Citation | 21 CFR 630.10(f)(4) |
|---|---|
| Section | General donor eligibility requirements |
| Part | PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE |
| Subpart | Subpart B-Donor Eligibility Requirements |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (4) Pulse. The donor's pulse must be regular and between 50 and 100 beats per minute. A donor with an irregular pulse or measurements outside these limits may be permitted to donate only when the responsible physician determines and documents that the health of the donor would not be adversely affected by donating. |
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