has demonstrated competence in the performance of their designated tasks;
has an adequate knowledge and understanding of the scientific/technical processes and principles relevant to their designated tasks;
understands the organisational framework, quality system and health and safety rules of the establishment in which they work, and
is adequately informed of the broader ethical, legal and regulatory context of their work.
a validated microbial inactivation or validated terminal sterilisation process is applied;
or, where it is demonstrated that exposure in a Grade A environment has a detrimental effect on the required properties of the tissue or cell concerned;
or, where it is demonstrated that the mode and route of application of the tissue or cell to the recipient implies a significantly lower risk of transmitting bacterial or fungal infection to the recipient than with cell and tissue transplantation;
or, where it is not technically possible to carry out the required process in a Grade A environment (for example, due to requirements for specific equipment in the processing area that is not fully compatible with Grade A).
OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.