ANSI AAMI ISO 22442-1:2016 pdf download – Medical devices utilizing animal tissues and their derivatives
4.4.2 Risk control for viruses and TSE agents
Risk control shall be implemented by separately addressing the risks related to different categories of viruses and TSE agents. After defining the characteristics of the product, the medical device manufacturer shall comply with the relevant requirements of both ISO 22442-2 and ISO 22442-3, except where either the animal species is such that manufacturers cannot fully meet the requirements of ISO 22442-2 or an inactivation process in accordance with ISO 22442-3 would cause unacceptable degradation. Tallow derivatives, animal charcoal, and amino acids that are acceptable for TSE risk as discussed in Annex C, due to their processing and not their sourcing, shall also be considered to have acceptable risk regarding viruses. Regarding TSE risk, risk control measures specified in Annex C for certain animal materials shall be applied where relevant. If the manufacturer considers any requirement not to be relevant, the rationale and justification shall be documented. For medical devices where an inactivation process causes unacceptable degradation, manufacturers may rely on ISO 22442-2 in order to meet the requirements of this part of ISO 22442. If the animal species is such that manufacturers cannot fully meet the requirements of ISO 22442-2, they shall demonstrate that the level of inactivation of transmissible agents in a validated manufacturing process, as required in ISO 22442-3, is sufficient to achieve an acceptable level of risk. NOTE Criteria and principles relevant to the management of TSE risks are described in Annex D. Annex D contains information on relevant risk control measures.
4.4.3 Risk control of other hazards
Risk control related to bacteria, moulds and yeasts, as well as undesired pyrogenic, immunological and toxicological reactions shall be implemented according to available standards. Tallow derivatives, animal charcoal, and amino acids that are acceptable for TSE risk as discussed in Annex C, due to their processing and not their sourcing, shall also be considered to have acceptable risk regarding bacteria, moulds and yeasts, subject to maintenance of proper storage conditions. The manufacturer shall conduct periodic microbiological studies to identify and quantify the initial bioburden of the incoming animal material for the production of the medical device.
This part of ISO 22442 can be applied when the materials used by medical device manufacturers have been prepared from animal sources by third parties or subcontractors. An example is gelatine derived from animal hides or bones. In considering the risks associated with the use of these products, the medical device manufacturers should seek evidence from their suppliers as to whether relevant requirements of this International Standard have been applied in assessing the suitability of the animal material or whether alternative approaches were applied. The information obtained should be incorporated in the risk management report relating to the medical device, as appropriate, but may need to be supplemented by information supplied by the third party or subcontractor.