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GB 18467-2011 English PDF

GB 18467-2011_English: PDF (GB18467-2011)
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GB 18467-2011English349 Add to Cart 3 days [Need to translate] Whole blood and component donor selection requirements Valid GB 18467-2011

Standard ID GB 18467-2011 (GB18467-2011)
Description (Translated English) Whole blood and component donor selection requirements
Sector / Industry National Standard
Classification of Chinese Standard C05
Classification of International Standard 11.020
Word Count Estimation 15,128
Date of Issue 2011-12-30
Date of Implementation 2012-07-01
Older Standard (superseded by this standard) GB 18467-2001
Quoted Standard GB 18469
Drafting Organization Beijing Red Cross Blood Center
Administrative Organization Ministry of Health
Regulation (derived from) Announcement of Newly Approved National Standards No. 23 of 2011
Proposing organization People's Republic of China Ministry of Health
Issuing agency(ies) Ministry of Health of People's Republic of China; Standardization Administration of China
Summary This Chinese standard specifies the general health screening blood donors for projects and requirements. This standard applies to general health screening blood for blood donors. Does not apply to blood stem cell donation, self storage and therapeutic apheresis blood.

Standards related to: GB 18467-2011

GB 18467-2011
Whole blood and component donor selection requirements
ICS 11.020
National Standards of People's Republic of China
Replacing GB 18467-2001
Donor health inspection requirements
Issued on. 2011-12-30
2012-07-01 implementation
People's Republic of China Ministry of Health
Standardization Administration of China released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 1 General
5 donors informed consent 1
6 healthy donors consulted 3
7 General examination 5 donors
8 5 blood tests before donation
9 blood donation and blood donation interval of 5
After 10 donation blood test 6
Appendix A (informative) informed consent and the health of blood donors consult Table 7
Annex B (informative) Examination and blood donation record 11
Chapter 4 of this standard, Chapter 5, Chapter 9, Chapter 10, Section 8.2, 8.3 are mandatory, the rest are recommended.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces GB 18467-2001 "donor health inspection requirements", compared with GB 18467-2001, the major technological change
as follows.
--- Adjust the standard structure, increase directory, reference documents, informed consent of donors, delete the original Appendix C;
--- Adjust normative technical provisions of chapter structure; the relevant provisions of the adjusted blood donation immunization, vaccine production process according to classification
--- Adjust mandatory provisions, in addition to the original pre-donation testing, blood volume and blood donation interval, donated blood testing requirements, increased blood
Informed consent;
--- Increase blood donors about life experiences and travel experience health consultation;
--- Deleting content blood test about the method to detect markers Once blood;
--- Adjust blood donation age, blood volume, hemoglobin standard, platelets and blood collection standard spacing;
--- Amendment ophthalmic disorders, homosexuality and the relevant provisions of the post-vaccination blood donation;
--- Revised Appendix A blood donor consent and Health Questionnaire related content;
--- Revised Appendix B before blood tests and blood donation records related content.
This standard is proposed and administered by the People's Republic of China Ministry of Health.
Drafting of this standard. Beijing Red Cross Blood Center.
The main drafters of this standard. High Tung Ying, Liu Jiang, Dai Suna, Guo Jin, Zhou Qian, Chen Xiao, Liu Zhiyong, Jiang Feng, Zhao Dongyan, Zhuangguang Yan.
This standard replaces the standards previously issued as follows.
--- GB 18467-2001.
Donor health inspection requirements
1 Scope
This standard specifies the general requirements for blood donors and project health check.
This standard applies to general health screening blood for blood donors.
This standard does not apply to blood stem cell donation, blood storage and its own therapeutic apheresis.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 18469 of whole blood and blood components quality
3 Terms and Definitions
GB 18469 and defined by the following terms and definitions apply to this document.
Fixed blood donors regularnon-remuneratedvoluntaryblooddonor
Offered at least three times the blood, and the blood at least once in the last 12 months.
After forecasting platelet count predictedpost-donationplateletcount
After the body of the remaining collection donor platelet count lower control limit for verifying the platelet collection scheme.
4 General
4.1 before collecting blood donors should obtain informed consent, and its necessary health consultation, general examination and blood tests. written
Log files, see Appendix A, Appendix B.
General examination and blood tests 4.2 blood donors before blood results should prevail, valid for 14d.
4.3 pre-donation medical examination Results for judging whether a suitable blood donors, not suitable for diagnostics donor health status or disease.
4.4 pairs by inappropriate health check blood donors should be given appropriate explanation and attention to the protection of their personal information.
5 donors informed consent
5.1 Obligation
Blood bank staff should be in front of the blood donors to fulfill this obligation in writing and made donors signed informed consent.
5.2 inform content
5.2.1 Motivation to donate blood
Blood donation is motivated by altruism, it aims to help patients requiring transfusion. Do not donate blood for the testing and. Countries
Free HIV counseling and free HIV antibody testing services, if necessary, please contact your local Center for Disease Control (electrical contact
Words can query the National Public Health Public hotline 12320).
5.2.2 The importance of safe blood donors
Unsafe blood to endanger life and health of the patient. Donors should not donate blood with a high-risk behavior such as intravenous drug history, MSM
Behavior or with blood-borne diseases (AIDS, hepatitis C, hepatitis B, syphilis and other) risks.
5.2.3 has a risk behavior deliberately donation responsibility
Infectious blood donors donate blood recipients will be dangerous, should bear the moral responsibility of the recipient.
According to "People's Republic of China Disease Prevention Act" Article 77, "AIDS Prevention Act," Article 38 and Article 62 of the high-risk offer
Deliberately blood donation, resulting in the spread of infectious diseases, epidemic, he shall bear civil liability; constitute a crime, be held criminally responsible.
5.2.4 real-name system to donate blood
According to "Blood management approach", donors before blood donation should produce a real and effective identification, blood should be checked and registered.
Fraudulent use of another person's identity to donate blood, should be held accountable in accordance with relevant laws and regulations.
5.2.5 donors after donation report back
If you think there may be blood donors have donated blood safety hazard, it shall inform the blood bank as quickly as possible. Blood should provide contact phone number.
5.2.6 Donating Blood Reaction
In most cases, blood donation is safe, but individuals may occasionally occur such as dizziness, cold sweats, puncture site bruising, hematoma, pain
And discomfort, very few may appear more serious blood reactions such as syncope. Medical personnel should be disposed of promptly reaction donation, blood donation
Caution should follow before and after blood donation and blood donation, blood donation to reduce the probability of occurrence of the reaction.
5.2.7 health consultation and examination
Under the "Blood Donation Law of People's Republic of China" shall consult healthy blood donors and general examination, blood donors must fill out
Health Status Questionnaire. Fill untrue who donated blood due to adverse effects caused by the recipient, should bear in accordance with relevant laws and regulations
5.2.8 Blood tests
Blood donors will comply with state regulations for blood to detect blood-borne diseases, blood tested and will be used for clinical failure
Blood will be disposed of in accordance with national regulations. Blood test results show only failed to donate blood do not meet national standards of blood, not for
Of infection or disease diagnosis.
5.2.9 epidemic reporting
According to relevant regulations, "People's Republic of China Disease Prevention Act" and so on, will be the local blood bank CDC reported HIV disease
Results such as testing positive for virus infection and its profile.
5.3 donors informed consent
Donors should carefully read the information related to informed consent, and signed informed consent.
6 healthy donors sought
6.1 donors have the following circumstances can not donate blood
6.1.1 respiratory diseases, such as including chronic bronchitis, bronchiectasis, bronchial asthma, emphysema, and pulmonary function not
6.1.2 circulatory system diseases, such as various heart diseases, hypertension, hypotension, limb atherosclerosis, thrombotic phlebitis.
6.1.3 digestive diseases, such as chronic gastroenteritis, treated with active or recurrent gastric and duodenal ulcers, chronic pancreas
Inflammation, nonspecific ulcerative colitis.
6.1.4 patients with urinary system diseases, such as acute and chronic glomerulonephritis, chronic pyelonephritis, nephrotic syndrome, acute and chronic urinary tract infections
Chronic renal insufficiency.
6.1.5 patients with blood disorders such as anemia (iron deficiency anemia, megaloblastic anemia except healer), polycythemia vera, grain
Cell deficiency, leukemias, lymphomas and various publications, blood clotting disorders.
6.1.6 endocrine system diseases and patients with metabolic disorders, such as pituitary and adrenal disease, thyroid functional disorders, diabetes, limb
Acromegaly, diabetes insipidus and so on.
6.1.7 patients with immune system diseases, such as systemic lupus erythematosus, dermatomyositis, scleroderma, rheumatoid arthritis, artery go far.
6.1.8 chronic skin diseases, especially infectious, allergic and systemic inflammatory skin diseases, such as yellow ringworm, eczema and systemic extensive cattle
Psoriasis and other skin.
6.1.9 recurrent allergic diseases and allergy sufferers, such as recurrent urticaria, bronchial asthma, drug allergy. Simple urticaria
During the acute attack can not donate blood.
6.1.10 Patients with neurological diseases, such as cerebrovascular disease, encephalitis, brain trauma sequelae, epilepsy, and seizures or a history of recurrent syncope hair
6.1.11 mental illness, such as depression, mania, schizophrenia, hysteria and so on.
6.1.12 g - Ya (Creutzfeldt-Jakob) and patients have a family history of, or acceptance may be derived from gram - Ya pathogen infection group
Tissue or tissue derivatives (such as the dura mater, cornea, human pituitary growth hormone) treatment.
6.1.13 variety of malignant tumors and benign tumors affect the health of patients.
6.1.14 Patients with infectious diseases, such as viral hepatitis patients and infected persons. (AIDS, AIDS) in patients with acquired immunodeficiency syndrome
And human immunodeficiency virus (HIV) infection. Leprosy and sexually transmitted infection patients and diseases, such as syphilis, Treponema pallidum infection
Who, gonorrhea, genital warts and the like.
6.1.15 variety of TB patients, such as tuberculosis, renal tuberculosis, lymphatic system and bone tuberculosis.
6.1.16 parasites and endemic disease patients, such as schistosomiasis, filariasis, hookworm, paragonimiasis, cysticercosis, liver fluke disease, kala-azar and g
Mountain disease and Kashin-Beck disease and the like.
6.1.17 some occupational diseases, such as radiation disease, pneumoconiosis, silicosis and harmful gases, toxic substances caused by acute and chronic poisoning.
6.1.18 Some drug users, such as long-term use of adrenal corticosteroids, immunosuppressive agents, hypnotic sedative, patients treated with psychotropic drugs
Person; previous or existing drug dependence, alcohol dependence or drug abuse, including smoking, ingestion or by intravenous, intramuscular, subcutaneous injection, etc. use
Steroids, hormones, narcotic or sedative-hypnotic drugs persons.
6.1.19 susceptible to blood-borne diseases in high-risk populations, if drug history, MSM and multiple sexual partners and the like.
6.1.20 allogeneic tissue and organ graft recipients. patients who had received allograft transplantation, including the acceptance of tissue, organ transplantation, such as dirty
, A skin, cornea, bone marrow, bone, dura mater transplantation.
6.1.21 received stomach, kidney, spleen, lungs and other vital internal organs resection.
6.1.22 has occurred so that donors and recipient of transfusion-associated infectious diseases.
Health care workers believe that patients with other diseases 6.1.23 inappropriate blood donation.
6.2 donors have the following circumstances temporarily can not donate blood
6.2.1 oral care (including scaling, etc.) after less than 3d; after tooth extraction or other minor under the age of two weeks; appendectomy, hernia repair and
After tonsillectomy recovery under 3 months; after less than six months by a larger surgery recovery.
6.2.2 benign. benign gynecological, surgical treatment of benign surface after less than 1 year.
6.2.3 women's menstrual period before and after 3d, pregnancy and abortion after less than 6 months, childbirth and breast-feeding has less than 1 year.
6.2.4 active or progressive eye disease have recovered less than 1 week, the prognosis eye surgery less than 3 months.
6.2.5 upper respiratory tract infection have recovered less than 1 week, pneumonia recovered less than 3 months.
6.2.6 acute gastroenteritis illness less than 1 week.
6.2.7 acute urinary tract infection have recovered less than 1 month, acute pyelonephritis recovered under the age of 3 months, urinary calculi attack.
6.2.8 wound healing or cure infections by less than one week after healing skin inflammation limitations under 1 week, extensive skin inflammation after healing
Under 2 weeks.
6.2.9 blood or tissue fluid contamination of equipment, injury or contamination of the wound and the purposes of the tattoo after less than 1 year.
6.2.10 close contact with patients with a history of infectious diseases, from the date of the contact until the maximum incubation period of the disease. Hepatitis recovered after less than one year
Who recovered less than half a year's dysentery, typhoid recovered less than 1 year, brucellosis recovered under the age of 2 years. Go to malaria epidemics 1 year
Zone or malaria who recovered less than three years after clinical recovery toxoplasmosis less than 6 months, Q heat completely cured under the age of 2 years.
6.2.11 oral inhibiting platelet function or damage of drugs (such as aspirin or aspirin-containing drugs) after stopping dissatisfied 5d who do not
Ingredients can offer apheresis platelet and whole blood platelet preparation.
Transfusion of whole blood and blood components by 6.2.12 1 year.
6.2.13 parasitic diseases. ascariasis, pinworm infection are not fully recovered.
6.2.14 acute rheumatic fever. less than 2 years after illness or sequelae.
6.2.15 sex. once with susceptible persons at high risk for blood-borne diseases have sex under the age of 1 year.
6.2.16 Travel history. there have been health pestilence or infectious disease is epidemic surveillance travel history to determine the administrative department of the State Council, entry time
Disease who are under the maximum incubation period.
6.3 after receiving vaccination or treatment of biological products blood donation regulations
6.3.1 No vaccination history of exposure receiving inactivated vaccines, recombinant DNA vaccines, toxoids injectors
No adverse reactions or illness who defer to 24h after receiving the vaccine donation, including. typhoid vaccine, freeze-dried Japanese encephalitis inactivated vaccine,
Adsorbed DPT vaccine, inactivated hepatitis A vaccine, recombinant hepatitis B vaccine, inactivated whole virus influenza vaccine. accept the live attenuated vaccine recipients
Measles, mumps, polio and other vaccine the last 2 weeks after immunization, or rubella vaccine, rabies immune
Seedlings, live attenuated JE vaccine donation before the last 4 weeks after immunization.
6.3.2 There vaccination history of exposure
After being bitten by the animal vaccinated against rabies, the last immunization before 1 year after donation.
6.3.3 Biological Products receiving treatment
Receiving anti-toxin serum and injected by. at 4 weeks after the last injection before donation, including tetanus antitoxin, anti-rabies blood
Qing. Who received the hepatitis B immunoglobulin injections by donation only after one year.
7 general examination of blood donors
7.1 Age. The state promotes blood donation age is 18 years old to 55 years old; no previous history of blood donation reaction, with health inspection requirements of multiple donors
Volunteered to donate blood again, age extended to 60 years of age.
7.2 Weight. Male ≥50kg, female ≥45kg.
7.3 Blood pressure.
12.0kPa (90mmHg) ≤ systolic blood pressure < 18.7kPa (140mmHg);
8.0kPa (60mmHg) ≤ diastolic blood pressure < 12.0kPa (90mmHg);
Pulse pressure. ≥30mmHg/4.0kPa.
7.4 pulse. 60 beats/min ~ 100 times/min, a high degree of endurance athletes ≥50 beats/min, rhythm and tidy.
7.5 temperature. normal.
7.6 General Health.
a) skin, sclera without yellow dye. Skin wound infection, a large area of skin diseases;
b) no limbs, severe disability and above, no serious dysfunction and no joint swelling;
c) arms venipuncture sites without skin damage. No intravenous drug traces.
8 blood tests before donation
8.1 Blood Detection. ABO blood group (positive-type).
8.2 Hemoglobin (Hb) determination. Male ≥120g/L; F ≥115g/L. Such as the use of copper sulfate method. Male ≥1.0520, female ≥1.0510.
8.3 apheresis platelet donors. In addition to meet the 8.2, it must also satisfy.
a) hematocrit (HCT). ≥0.36;
b) preharvest platelet count (PLT). ≥150 × 109/L and < 450 × 109/L;
c) the number of platelets forecast harvest (PLT). ≥100 × 109/L.
9 blood donation and blood donation interval
9.1 blood volume
9.1.1 Whole blood donors can offer each whole blood 400mL, or 300mL, or 200mL.
9.1.2 apheresis platelet donors. each can offer 1-2 treatment units, or a treatment units and not more than 200mL plasma.
Annual platelet and plasma collection does not exceed the total amount of 10L.
Note. The above does not include the amount of blood volume and maintenance of blood anticoagulant fluid or blood test retention samples.
Donation interval 9.2
9.2.1 Whole blood donation interval. less than 6 months.
9.2.2 apheresis platelet donation interval. less than 2 weeks and no more than 24 times/year. Due to special needs matching by a doctor approved, the shortest interval
Not less than one week.
9.2.3 apheresis platelets and whole blood donation interval. at least 4 weeks.
9.2.4 After the donation of whole blood and apheresis platelet donation interval. less than 3 months.
10 blood donors after blood tests
10.1 Blood Detection. ABO and RhD blood group correctly stereotypes.
10.2 alanine aminotransferase (ALT). comply with the relevant requirements.
10.3 hepatitis B virus (HBV) test. meet the requirements.
10.4 Hepatitis C virus (HCV) test. meet the requirements.
10.5 AIDS virus (HIV) test. meet the requirements.
10.6 Syphilis (Syphilis) test. meet the requirements.
Appendix A
Informed consent and the health of blood donors Questionnaire
A.1 informed consent and the health of blood donors consult the following table.
Dear Friends.
Hello Thank you for participating in voluntary blood donation.
For your own health and safety of the recipient, please carefully read and fill out the questionnaire in the content. Any of the following problems
Even if you answered "yes" does not necessarily mean that you can not donate blood or after today. If you have any doubt, please consult the health care provider. Thank you
Understanding and support.
You should know the contents of the first part before blood donation
1. Safe blood saves lives, unsafe blood was able to endanger life. Safe blood can only come from altruism to
Motivation and having a healthy lifestyle donors. Make high-risk actors (if history of intravenous drug users, MSM, AIDS or sexually transmitted diseases, etc.)
Do not donate blood. If you know that there are high-risk behavior and deliberately to donate blood, resulting in the spread of infectious diseases, epidemic, according to "People's Republic of China Anti-infectious diseases
Governing Law "Article 77," AIDS Prevention Act, "Article 38 and Article 62 may be held corresponding civil liability.
2. Please do not order tests and blood. State provides free HIV counseling and testing services, if necessary, contact your local disease control
Center (Tel can query the National Public Health Public hotline 12320).
3. In order for your health and to evaluate the suitability of blood donation, you will need to fill out the health of Questionnaire. If the table
Questions related to your privacy or make you feel uncomfortable, please understand.
4. "blood bank management approach", donors before blood donation should produce true identity, blood banks should make verification and registration, please
I support.
5. If you think there may have been donated blood safety problems, please let us know (contact phone the first time. ××××
6. The donation process is safe. Use disposable sterile blood collection supplies to ensure safe blood donors. Some people occasionally appear as
Puncture site bruising, bleeding or pain, dizziness and discomfort after blood donation, these complaints are minor or transitory. Each offer urge donors follow
Blood before, after should pay attention to minimize discomfort may occur in the blood.
7. Blood strict compliance with the provisions of the national blood test, blood will be tested and used in clinical, blood will be substandard in accordance with national regulations
Set processing. Blood test results show that you only fail to donate blood do not meet national standards, not as a disease or infection
8. "Communicable Disease Prevention Law" stipulates that the AIDS blood test positive results and their personal data to the local disease control
Heart reports. Our commitment to your information strictly confidential.
Before the second part of the donation health consultation (Please indicate with "√")
Today/now whether
1. Do you think today's medically fit to donate blood? □ □
2. If you are awaiting inspection report of the hospital or are receiving some kind of treatment? □ □
3. If you are going to donate blood today dangerous sport? (Eg. mountain climbing, scuba diving or paragliding) drivers of heavy vehicles?
In underground or aerial work? (Eg. flight, firefighters, scaffolding work) □ □
Today/now whether
4. One of the purposes of your blood, do not want to know your body is healthy? There are not infected by AIDS
Virus or syphilis or other diseases? □ □
5. Did you know that if you are infected with HIV or syphilis, even when you feel okay, test results show
Negative, may also transmit the virus to others? □ □
6. (Women fill in) You are now is in the menstrual period before and after three days? Are pregnant? Are In
In the past year within six months of childbirth or abortion? □ □
Whether in the past 24 hours
7. Have you ever injected toxoid, inactivated vaccine or genetic engineering techniques made (including cholera, typhoid,
Diphtheria, tetanus, hepatitis A, hepatitis B, influenza, polio or whooping cough, and there is no
Illness or adverse reactions? □ □
In the past three days whether
8. ever receive any oral care (including scaling, etc.)? □ □
In the past five days if
9. Are taking aspirin or aspirin-containing drugs? □ □
In the past week whether
10. Do you have a fever, headache or diarrhea? Ever suffer from colds, acute gastroenteritis? Are not there any
Healing wounds or skin inflammation? □ □
In the past two weeks whether
11. stayed tooth? Ever suffer from generalized inflammation? Are there other minor surgery? □ □
12. Has ever injection of live attenuated vaccines such as measles, mumps, yellow fever, polio, etc.? □ □
In the past four weeks whether
13. ever contagious patients, such as. chicken pox, measles, tuberculosis and other □ □?
14. Are had received live attenuated vaccine, such as. typhoid vaccine, rubella vaccine, rabies vaccine, varicella vaccine □ □?
15. Are there unexplained diarrhea? □ □
Whether in the past year
16. ever tattoo, body piercing or acupuncture has been used and other injuries? Stayed accidental contact with blood or blood
Contaminated equipment? □ □
17. ever injection of hepatitis B immunoglobulin? □ □
18. animal bites and therefore has been vaccinated against rabies? □ □
19. ever undergo a surgical procedure (including endoscopy, using a catheter for treatment)? Or accept blood transfusions? □ □
Whether health history
20. Have you had the following cases. □ □
1) receiving clotting factor therapy? Accept the pituitary hormone drugs such as growth hormone therapy?
2) you or immediate family members are suffering from Creutzfeldt-Jakob disease (mad cow disease)?
3) whether there syncope, seizures, convulsions or loss ...