GB18467-2011
Whole blood and component donor selection requirements
献血者健康检查要求
GB 18467-2011 is a current mandatory Chinese national standard for Whole blood and component donor selection requirements. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jul 1, 2012.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard specifies the health examination items and requirements for blood donors at general blood stations in China. It is strictly applicable to the selection and evaluation of whole blood and component donors. This standard does not apply to hematopoietic stem cell donation, autologous blood storage, or therapeutic apheresis. Facilities involved in blood collection must adhere to these guidelines to ensure both donor safety and blood supply integrity.
Technical requirements
The standard outlines mandatory provisions for informed consent, health inquiry, and donation intervals. Blood stations must obtain written informed consent before collection, ensuring donors are fully aware of safety protocols and legal responsibilities. The health inquiry section details extensive exclusion criteria, permanently barring individuals with severe cardiovascular, respiratory, or infectious diseases, as well as those with high-risk behaviors. It also references GB 18469 for related quality requirements. General physical examinations establish baseline thresholds for donor eligibility, including age limits, weight, blood pressure, and pulse rate parameters. For instance, the standard permits regular donors with a clean health history to donate up to age 60. Donors must meet specific physical condition criteria without active skin infections or severe disabilities. The standard regulates donation volume and intervals to protect donor health. It specifies exact collection amounts for whole blood and apheresis platelets, alongside strict minimum time intervals between donations. Blood stations must enforce these intervals rigorously to prevent donor thrombocytopenia or anemia. Pre-donation testing mandates ABO blood typing and hemoglobin level verification.
Testing methods
Testing procedures are divided into pre-donation and post-donation evaluations. Pre-donation testing focuses on immediate eligibility markers like ABO blood typing and hemoglobin concentration, utilizing methods such as the copper sulfate specific gravity method. Post-donation testing mandates comprehensive screening for transfusion-transmissible infections, including HBV, HCV, HIV, and Syphilis, alongside ALT level checks. These procedures ensure compliance with national blood safety protocols.
FAQs
What products and facilities are regulated under GB 18467-2011?
GB 18467-2011 applies to general blood stations performing health checks on whole blood and component donors. It does not apply to hematopoietic stem cell donation, autologous blood storage, or therapeutic apheresis.
Are there any significant updates from the previous GB 18467-2001 version?
The 2011 version introduces mandatory informed consent for donors, adjusts the upper age limit for regular donors to 60 years, and revises donation intervals and apheresis collection standards. It also adds health inquiries regarding donors' lifestyle and travel histories.
How does GB 18467-2011 differ from international blood donation standards?
While GB 18467-2011 aligns with general international blood safety principles, it incorporates specific Chinese legal requirements, such as real-name registration and strict local reporting protocols for positive infectious disease results. Compliance requires strict adherence to these localized regulatory frameworks.
The summary above provides a high-level overview of GB 18467-2011. To ensure complete compliance for your medical devices or blood bank operations entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 18467-2011 today to access all detailed parameters, health questionnaires, and testing procedures.
Applicability hints
- Type
- Health and hygiene
- CCS
- C05
- ICS
- 11.020
- Competent department
- National Health Commission
- Technical committee
- National Health Commission
Relationships
Replaces:GB 18467-2001