ANNEX IU.K.Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Article 3

C.EQUIPMENT AND MATERIALSU.K.

1.All equipment and material must be designed and maintained to suit its intended purpose and must minimise any hazard to recipients and/or staff.U.K.

2.All critical equipment and technical devices must be identified and validated, regularly inspected and preventively maintained in accordance with the manufacturers' instructions. Where equipment or materials affect critical processing or storage parameters (e.g. temperature, pressure, particle counts, microbial contamination levels), they must be identified and must be the subject of appropriate monitoring, alerts, alarms and corrective action, as required, to detect malfunctions and defects and to ensure that the critical parameters are maintained within acceptable limits at all times. All equipment with a critical measuring function must be calibrated against a traceable standard if available.U.K.

3.New and repaired equipment must be tested when installed and must be validated before use. Test results must be documented.U.K.

4.Maintenance, servicing, cleaning, disinfection and sanitation of all critical equipment must be performed regularly and recorded accordingly.U.K.

5.Procedures for the operation of each piece of critical equipment, detailing the action to be taken in the event of malfunctions or failure, must be available.U.K.

6.The procedures for the activities for which accreditation/designation/authorisation/licensing is sought, must detail the specifications for all critical materials and reagents. In particular, specifications for additives (e.g. solutions) and packaging materials must be defined. Critical reagents and materials must meet documented requirements and specifications and when applicable the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(2).U.K.