ISO 22442-2:2020 動物組織とその派生物を利用する医療機器—パート2：調達、収集、取り扱いの管理 | ページ 6

3.1

collection

removal of tissues from animals

3.2

closed herd

herd governed by standard operating procedures (SOPs) that specify criteria restricting admission of new animals to ensure that all introduced animals are at the same or higher health standard, compared to the residents of the herd

Note 1 to entry: Such SOPs typically include:

Note 2 to entry: a) a documented veterinary monitoring process;

Note 3 to entry: b) a fully documented disease history, including a fully documented negligible TSE risk status of the herd including logged TSE history;

Note 4 to entry: c) a process to prevent feeding of mammalian-derived protein, including a fully documented feed history, source and traceability;

Note 5 to entry: d) a fully documented breeding history;

Note 6 to entry: e) a fully documented use of veterinary medicines and vaccines;

Note 7 to entry: f) a process of traceability towards each individual animal;

Note 8 to entry: g) a process to control introduction of genetic material from animals outside the closed herd, including from herds with the deviating TSE status;

Note 9 to entry: h) a fully documented record of animals kept with or in close proximity to the closed herd and procedures to control vermin or pest.

3.3

veterinarian

person designated by the relevant competent authority as suitably qualified for the responsibility delegated to him or her relating to ante- and post-mortem inspection of animals and/or relevant certification

Note 1 to entry: Under certain jurisdictions, it is a requirement that the veterinarian be a professionally qualified person in veterinary medicine.

Note 2 to entry: Under certain jurisdictions, the function of inspection and of certification can be carried out by different individuals. In such cases, the certificate can be signed by a person who is not designated by the competent authority. This function is covered in the quality management system of the medical device manufacturer.