ANSI AAMI ISO 22442-2-2016 pdf download
ANSI AAMI ISO 22442-2-2016 pdf download.Medical devices utilizing animal tissues and their
derivatives
1 Scope
This part of ISO 22442 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 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management. The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 1 3485. NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
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.
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.
