You must comply with this standard if you are involved in the preparation of goods which contain materials of human origin and are intended as laboratory reagents for diagnostic tests.
You are exempt from complying with this licence if either the goods prepared:
- have been heat treated at 60 degrees C for 10 hours
- cannot be prepared from material that is non-reactive when testing for Hepatitis B virus or antibody to HIV.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.