ANSI AAMI ISO 22442-2 pdf free download

ANSI AAMI ISO 22442-2 pdf free download.Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling.
4 General requirements 4.1 General Apply the requirements of this part of ISO 22442 as determined by the 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. This system shall address the animal source and the following factors: a) specification 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; NOTE 1 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 also 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 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 2 The use of risk analysis/risk management tools [such as HACCP, FMEA (see ISO 1 4971 :2007, Annex G)] are useful in determining residual risk. 4.3 Procedures The documented procedures and instructions required by this part of ISO 22422 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 part of ISO 22442. 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, the nature of 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. ANSI AAMI ISO 22442-2 pdf download.