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GB 18467-2011 English PDF

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US$349.00 · In stock
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GB 18467-2011: Whole blood and component donor selection requirements
Status: Valid

GB 18467: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 18467-2011	349	Add to Cart	3 days	Whole blood and component donor selection requirements	Valid
GB 18467-2001	839	Add to Cart	6 days	Health examination criteria of blood donors	Obsolete

Similar standards

WS/T 655 GB/T 36388 WS/T 367 GB/T 27772 GB/T 44804

Basic data

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: 15,125
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Older Standard (superseded by this standard): GB 18467-2001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
Regulation (derived from): Announcement of Newly Approved National Standards No. 23 of 2011
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic 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.

GB 18467-2011: Whole blood and component donor selection requirements

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Whole blood and component donor selection requirements ICS 11.020 C05 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

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

Foreword

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 management; --- 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. 3.1 Fixed blood donors regularnon-remuneratedvoluntaryblooddonor Offered at least three times the blood, and the blood at least once in the last 12 months. 3.2 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 responsibility. 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 congruent. 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 OF. 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 6.3.1.1 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. 6.3.1.2 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

(Informative) 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 Unde......

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Question 5: Should I purchase the latest version GB 18467-2011?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 18467-2011 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.