GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives-Part 2 : Controls on sourcing, collection and handling
1 Scope
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1.
Note: Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
Note: GB/T 44353.1- 2024 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22442-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
—ISO online browsing platform: available at https://www.iso.org/obp
—IEC Electropedia: available at http://www.electropedia.org/
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: Such SOPs typically include:
a) a documented veterinary monitoring process;
b) a fully documented disease history, including a fully documented negligible TSE risk status of the herd including logged TSE history;
c) a process to prevent feeding of mammalian-derived protein, including a fully documented feed history, source and traceability;
d) a fully documented breeding history;
e) a fully documented use of veterinary medicines and vaccines;
f) a process of traceability towards each individual animal;
g) a process to control introduction of genetic material from animals outside the closed herd, including from herds with the deviating TSE status;
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: In some countries and regions, it is a requirement that the veterinarian be a professionally qualified person in veterinary medicine.
Note 2: In some countries and regions, 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.
4 General requirements
4.1 General
Apply the requirements of this document as determined by the benefit-risk-assessment (see ISO 22442-1).
Annex A shall be applied as appropriate.
4.2 Quality system elements
A documented system shall be established and maintained to control the quality of materials of animal origin and shall be verified by the medical device manufacturer. Specific requirements relating to collection are included in Clause 6.
Compliance is checked by inspection of the appropriate documents, including:
a) specification of the age and of the geographical origin (such as country or region) of the animal material, state of health of the animals, and acceptance criteria for animals taking into account the source-species, perceived risk from pathogens, and ability to obtain appropriate assurances, including full traceability to the slaughterhouse.
The geographical origin can include the animal's place of birth and the countries or regions in which it has lived during its lifetime as well as its place of slaughter. It is advisable that the manufacturer document the extent to which the geographical origin of the animal can be traced taking into account the application of risk management (see ISO 22442-1);
b) hygiene and quality assurance requirements to be met by the slaughterer including the provisions in the slaughterhouse to prevent cross-contamination within and between animals;
c) procedures for the collection, preservation, handling, storage, and transport of materials of animal origin;
d) documented evidence of the effectiveness of controls defined in a), b), and c);
e) records to be maintained [including as a minimum items a), b), c), and d). See 5.5.
For the control of processed animal material suppliers, the medical device manufacturer shall document, to the extent feasible, the practices of the specialized industries to which clauses of the various parts of ISO 22442 (all parts) have been applied.
Manufacturers should apply relevant provisions of ISO 22442 to natural substances such as milk, hair, and wool, although these are not covered by the definition of derivatives.
Note: The use of risk analysis/risk management tools (such as HACCP, FMEA) are useful in determining residual risk.
4.3 Procedures
The documented procedures and instructions required by this document shall be established, implemented, and maintained. These procedures and instructions shall be approved on issue and shall be controlled as follows.
The manufacturer shall establish and maintain procedures to control all documents and data that relate to the requirements of this document. These documents shall be reviewed and approved for adequacy by authorized personnel prior to issue.
This control shall ensure that:
a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed, and
b) obsolete documents are promptly removed from all points of issue or use.
Changes to documents shall be reviewed and approved by the same functions/organizations that performed the original review and approval unless specifically designated otherwise. The designated organizations shall have access to pertinent background information upon which to base their review and approval.
Where practicable, each change shall be identified in the document or the appropriate attachments.
A master list or equivalent document control procedure shall be established to identify the current revision of documents in order to preclude the use of non-applicable documents.
4.4 Personnel
Responsibility for the collection, handling, and storage of materials shall be assigned to qualified personnel as follows.
The manufacturer shall establish and maintain procedures for identifying the training needs and provide for the training of all personnel performing activities affecting quality.
The manufacturer shall ensure that personnel performing specific assigned tasks are qualified on the basis of appropriate education, training, and/or experience as required. Appropriate records of training shall be maintained.
Personnel directly involved in the collection and handling of material of animal origin shall be personnel employed by the device manufacturer or designated and adequately trained abattoir employees or the equivalent. The same requirements apply to personnel of all subcontractors.
The manufacturer shall identify the in-house verification requirements and shall provide adequate resources and assign trained personnel for verification activities.
Audits shall be carried out by personnel independent of those having direct responsibility for the work being performed.
4.5 Current regulatory requirements and guidance
Due account shall be taken of relevant current national and regional regulatory requirements or guidance including the OIE International Animal Health Code [4], [13].
5 Sourcing
5.1 General
Subclauses 5.2 to 5.6 and Clauses 6 to 8 shall be applied by the suppliers of animal materials, intermediaries, and medical device manufacturers as relevant under the risk management plan in compliance with ISO 22442-1.
The animal material shall not be compromised by cross-contamination before, during, or after slaughter. Animals shall be confirmed as having been declared fit for human consumption (see 5.5).
For the animal material sourced from species that are not intended for human consumption the justification for the missing inspection and certification is to be documented. Relevant quality criteria for this type of material are to be defined by the manufacturer.
It is the responsibility of the manufacturer to ensure that the material is fit for its intended use.
In case animal by-products not intended for human consumption are sourced, these have to be 'Category 3 (i.e. safe) materials or equivalent'.
5.2 Species and strain
For each material or derivative, the risk of certain diseases is dependent on the animal species and possibly strain, and this shall be taken into account for the establishment of control measures.
Note: Specific guidance as regards requirements for bovine blood can be found in the “Guideline on the use of bovine serum in the manufacture of human biological medicinal products” [14].
5.3 Geography
The risk of certain diseases is dependent on the geographical origin and this shall be taken into account for the establishment of control measures.
Geographical origin can include conception, birth, rearing, and slaughtering (for bovine species, see Annex A)
If required by the risk management process, in the case of domesticated/farmed species, the geographical region/country of birth and the summary of main locations of residence up to time of slaughter shall be recorded.
In the case of wild species, the country/region of birth shall be recorded if known. The use of wild mammalian species shall be addressed in the risk assessment (see ISO 22442-1).
