Donor Health Standards
2025-07-02
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Article 1
These standards are established in accordance with Article 14, Paragraph 2 of The Plasma Derivatives Act.
Article 2
Individuals shall meet the following criteria to be eligible to donate blood:
1. Age:
(1) Shall be between 16 and 65 years old.
(2) Donors over 65 shall have a blood donation record within the past two years. Donors over 70 shall also obtain physician approval.
2. Weight:
(1) Whole blood donation: at least 45 kg.
(2) In addition to whole blood donation, apheresis donations (platelets, leukocytes, or plasma): at least 50 kg.
3. Body Temperature: Oral or ear temperature: not exceeding 37.5°C. Forehead temperature: not exceeding 37.0°C.
4. Blood Pressure: Systolic: 90–160 mmHg. Diastolic: 50–95 mmHg. If pulse pressure (difference between systolic and diastolic) is less than 30 or greater than 90 mmHg, physician approval is required.
Blood collection institutions shall, for donors, perform the confirmation specified in Subparagraph 1 of the preceding paragraph and conduct tests specified in Subparagraphs 2 through 4.
1. Age:
(1) Shall be between 16 and 65 years old.
(2) Donors over 65 shall have a blood donation record within the past two years. Donors over 70 shall also obtain physician approval.
2. Weight:
(1) Whole blood donation: at least 45 kg.
(2) In addition to whole blood donation, apheresis donations (platelets, leukocytes, or plasma): at least 50 kg.
3. Body Temperature: Oral or ear temperature: not exceeding 37.5°C. Forehead temperature: not exceeding 37.0°C.
4. Blood Pressure: Systolic: 90–160 mmHg. Diastolic: 50–95 mmHg. If pulse pressure (difference between systolic and diastolic) is less than 30 or greater than 90 mmHg, physician approval is required.
Blood collection institutions shall, for donors, perform the confirmation specified in Subparagraph 1 of the preceding paragraph and conduct tests specified in Subparagraphs 2 through 4.
Article 3
Donation shall be deferred under any of the following conditions:
1. Active tuberculosis, heart disease, gastrointestinal ulcer with bleeding, kidney disease, cold, acute infection, communicable disease, allergic condition, or diabetes requiring insulin treatment.
2. Pregnancy, or within six months after miscarriage or childbirth.
3. Major surgery or blood transfusion within the past year.
4. Dental scaling, tooth extraction, root canal treatment, or dental implantation within the past seven days.
5. Use of medications affecting platelet or coagulation function within the past seven days.
6. Received a live-attenuated vaccine within the past 28 days.
7. History within the past year of high-risk sexual behavior or sexually transmitted diseases such as syphilis, gonorrhea, chlamydia, genital herpes, chancroid, condyloma acuminatum, or other STDs.
8. Gotten a tattoo within the past year.
9. Sexual activity within the past year with individuals who may be HIV-positive or who engage in sex work.
10. Suspected HIV infection.
11. Positive test for hepatitis B surface antigen or nucleic acid.
12. Positive test for hepatitis C antibody or nucleic acid.
13. Viral hepatitis or close contact with a hepatitis patient within the past six months.
14. West Nile virus infection within the past four months, or departure from a West Nile virus endemic area within the past month.
15. Dengue virus infection within the past month, or departure from a dengue-endemic area within the past month.
16. Zika virus nucleic acid positive, recovery within the past month, or departure from a Zika-endemic area within the past month.
17. Sexual activity within the past month with men who:
(1) Had Zika virus infection within the past three months.
(2) Departed from a Zika-endemic area within the past three months.
18. Malaria within the past three years, or departure from a malaria-endemic area within the past three months.
19. Continuous residence in a malaria-endemic area for more than five years, with less than three years since leaving.However, for individuals who have returned to and then departed again from a malaria-endemic area within three years, the deferral period for blood donation shall be recalculated.
20. Severe Acute Respiratory Syndrome (SARS): recovery within the past three months.
21. Departure from a SARS-endemic area within the past month, or close contact with a SARS patient within the past month.
22. Any other condition that, based on evaluation by the blood collection agency, may endanger the health of the donor or recipient.
Determination of epidemic regions mentioned in Subparagraphs 14 to 19 and 21 of the preceding paragraph shall follow Article 8 of the Communicable Disease Control Act.
1. Active tuberculosis, heart disease, gastrointestinal ulcer with bleeding, kidney disease, cold, acute infection, communicable disease, allergic condition, or diabetes requiring insulin treatment.
2. Pregnancy, or within six months after miscarriage or childbirth.
3. Major surgery or blood transfusion within the past year.
4. Dental scaling, tooth extraction, root canal treatment, or dental implantation within the past seven days.
5. Use of medications affecting platelet or coagulation function within the past seven days.
6. Received a live-attenuated vaccine within the past 28 days.
7. History within the past year of high-risk sexual behavior or sexually transmitted diseases such as syphilis, gonorrhea, chlamydia, genital herpes, chancroid, condyloma acuminatum, or other STDs.
8. Gotten a tattoo within the past year.
9. Sexual activity within the past year with individuals who may be HIV-positive or who engage in sex work.
10. Suspected HIV infection.
11. Positive test for hepatitis B surface antigen or nucleic acid.
12. Positive test for hepatitis C antibody or nucleic acid.
13. Viral hepatitis or close contact with a hepatitis patient within the past six months.
14. West Nile virus infection within the past four months, or departure from a West Nile virus endemic area within the past month.
15. Dengue virus infection within the past month, or departure from a dengue-endemic area within the past month.
16. Zika virus nucleic acid positive, recovery within the past month, or departure from a Zika-endemic area within the past month.
17. Sexual activity within the past month with men who:
(1) Had Zika virus infection within the past three months.
(2) Departed from a Zika-endemic area within the past three months.
18. Malaria within the past three years, or departure from a malaria-endemic area within the past three months.
19. Continuous residence in a malaria-endemic area for more than five years, with less than three years since leaving.However, for individuals who have returned to and then departed again from a malaria-endemic area within three years, the deferral period for blood donation shall be recalculated.
20. Severe Acute Respiratory Syndrome (SARS): recovery within the past three months.
21. Departure from a SARS-endemic area within the past month, or close contact with a SARS patient within the past month.
22. Any other condition that, based on evaluation by the blood collection agency, may endanger the health of the donor or recipient.
Determination of epidemic regions mentioned in Subparagraphs 14 to 19 and 21 of the preceding paragraph shall follow Article 8 of the Communicable Disease Control Act.
Article 4
Individuals with the following conditions are permanently ineligible to donate blood:
1. History of malignant tumors or leukemia.
2. Chronic alcoholism, intravenous drug addiction, or past use of illicit drugs.
3. Men who have sex with men.
4. Long-term use of blood-derived products.
5. HIV infection or positive/suspected HIV test result.
6. Confirmed positive for HTLV-I antibodies.
7. History of any form of Creutzfeldt–Jakob Disease (CJD); family history of genetic (familial) CJD within second-degree relatives; or determination by health authorities as having been exposed to iatrogenic CJD risk.
8. Receipt of human pituitary growth hormone extracted from cadavers or a human dura mater graft.
9. History of sex work.
10. Any other condition that, based on evaluation by the blood collection agency, may endanger the health of the donor or recipient.
1. History of malignant tumors or leukemia.
2. Chronic alcoholism, intravenous drug addiction, or past use of illicit drugs.
3. Men who have sex with men.
4. Long-term use of blood-derived products.
5. HIV infection or positive/suspected HIV test result.
6. Confirmed positive for HTLV-I antibodies.
7. History of any form of Creutzfeldt–Jakob Disease (CJD); family history of genetic (familial) CJD within second-degree relatives; or determination by health authorities as having been exposed to iatrogenic CJD risk.
8. Receipt of human pituitary growth hormone extracted from cadavers or a human dura mater graft.
9. History of sex work.
10. Any other condition that, based on evaluation by the blood collection agency, may endanger the health of the donor or recipient.
Article 5
Donation volume is regulated as follows:
1. Whole blood:
(1) Standard: 250 mL per donation.Donors weighing ? 60 kg may donate 500 mL per session.
(2) Annual limit: 1,500 mL for men; 1,000 mL for women.
2. Apheresis donations: Up to 500 mL per donation. Annual limit: 12 liters.
The blood volumes specified in Subparagraphs 1 and 2 of the preceding paragraph are calculated separately.
1. Whole blood:
(1) Standard: 250 mL per donation.Donors weighing ? 60 kg may donate 500 mL per session.
(2) Annual limit: 1,500 mL for men; 1,000 mL for women.
2. Apheresis donations: Up to 500 mL per donation. Annual limit: 12 liters.
The blood volumes specified in Subparagraphs 1 and 2 of the preceding paragraph are calculated separately.
Article 6
Minimum intervals between donations:
1. Whole blood:
(1) For donors who gave 250 mL: at least two months.
(2) For donors who gave 500 mL: at least 3 months.
2. Apheresis donations: at least 2 weeks.
1. Whole blood:
(1) For donors who gave 250 mL: at least two months.
(2) For donors who gave 500 mL: at least 3 months.
2. Apheresis donations: at least 2 weeks.
Article 7
Blood collection institutions shall test all collected blood. Required testing items are listed in the appendix.
- Appendix Required Blood Tests.odt
Article 8
These standards shall take effect on the date of promulgation.