Британские нормативные документы
Great Britain Requlation



Реклама и продвижение лекарственных средств в Великобритании THE BLUE GUIDE
Medicines and Healthcare products Regulatory Agency
Health Technical Memorandum 2010
Part 1: Management policy
Management policy – is a summary of the information required by non-technical personnel responsible for the management of sterilization services. It discusses the various types of sterilizer, for both clinical and laboratory use, and contains guidance on legal and policy matters, and on the appointment and responsibilities of personnel. It should be read by anyone consulting this memorandum for the first time;
Health Technical Memorandum 2010
Part 2 : Design considerations
Sterilization 95 pages
Design considerations – contains information relevant to the specification and installation of new sterilizing equipment. It discusses the requirements for each type of sterilizer and outlines the specifications to be included in any contract. Practical considerations for the installation of sterilizers are discussed, including siting, heat emission, ventilation, noise and vibration, and mains services with an emphasis on steam quality;
Health Technical Memorandum 2010
Part 3 (Including Amendment 1): Validation and verification
189 pages
Validation and verification – covers all aspects of validation and periodic testing of
sterilizers. It includes detailed schedules and procedures for tests and checks to be carried out for commissioning and performance qualification, and for subsequent periodic testing;
Health Technical Memorandum 2010
Part 4: Operational management (New edition) with
Part 6: Testing and validation protocols
Sterilization. 245 pages

Operational management – covers all aspects of the routine operation and maintenance of sterilizers, stressing the need for a planned maintenance programme along with the type of records to be kept. Advice on the safe and efficient operation of sterilizers is given, as well as procedures for reporting defects and accidents

Health Technical Memorandum 2010
Part 5: Good practice guide
Sterilization. 166 pages
Good practice guide – provides advice on the fatigue life of pressure vessels, operational procedures guidance on the control of sterilizers, and use of the supplementary publications (logbooks etc.). It also includes a comprehensive bibliography.