For the purposes of this Regulation, the following definitions apply in addition to the definitions set out in F1the Medical Devices Regulations 2002:

1. (a)

   ‘cell’ means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;

2. (b)

   ‘tissue’ means an organisation of cells, extra-cellular constituents or both;

3. (c)

   ‘derivative’ means a material obtained from animal tissue through one or more treatments, transformations or steps of processing;

4. (d)

   ‘non-viable’ means having no potential for metabolism or multiplication;

5. (e)
   ‘TSEs’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001 of the European Parliament and of the Council9;
6. (f)

   ‘TSE infectious agents’ means unclassified pathogenic agents which are capable of transmitting TSEs;

7. (g)

   ‘reduction, elimination or removal’ means a process by which the number of TSE infectious agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;

8. (h)

   ‘inactivation’ means a process by which the ability to cause infection or pathogenic reaction by TSE infectious agents is reduced;

9. (i)

   ‘source country’ means the country or countries in which the animal was born, has been reared and/or has been slaughtered;

10. (j)

    ‘starting materials’ means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.