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11.5: References Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ, L 331, 07.12.1998, p1.
11.4: Recommended serological techniques for reagent testing 11.4.1: Potency titrations 11.4.1.1: Introduction The use of a semi-automatic pipette is recommended; o…
11.3: Reference preparations 11.3.1: Introduction One of the major regulatory requirements is a requirement for traceability to reference materials of higher order. In the cas…
11.1: Guidelines for reagent manufacture 11.1.1: Introduction All reagents used to determine the group of human red cells and to detect red cell antibodies must comply with Me…
2.4: Systems 2.4.1: Quality management system Within a Blood/Tissue Establishment an effective quality management system (QMS) is a well-designed, structured and organised met…
2.8: References Statutory Instrument 2005 No. 50. The Blood Safety and Quality Regulations 2005. Available at www.legislation.gov.uk
2.5: Application of a quality management system 2.5.1: Blood Establishments Blood Establishments are required under Directive 2005/62/EC7 to implement …
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