ANSI AAMI ISO 22442-1 pdf free download

ANSI AAMI ISO 22442-1 pdf free download.Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management.
4 Risk management process 4.1 General The manufacturer shall justify the use of animal material (including the choice of animal species and tissues) based on the residual risk acceptability, taking into account the balance of residual risk and expected medical benefit, as compared to available alternatives. The requirements of ISO 1 4971 and 4.2 to 4.5 apply. Compliance with these requirements shall be verified by inspection of the risk management file. NOTE Further discussion of medical benefits and the risk/benefit analysis can be found in ISO 1 4971 :2007, D.6. 4.2 Risk analysis Identification of qualitative and quantitative characteristics related to the safety of medical devices 4.2.1 4.2.1.1 Does the device come into contact with the patient or other persons? The quantity of material, the contact surface area and the type(s) of the material coming into contact with body tissues or fluids as well as the type of body tissue or fluid it comes into contact with, shall be addressed in the risk analysis. For TSE, guidance can be found in D.3.7. NOTE 1 Medical devices such as orthopaedic shoes or components such as leather straps that come into contact only with intact skin represent a low infective risk. NOTE 2 The quantity of material coming into contact is one of the factors in producing biological effects. See ISO 10993 (all parts) for the evaluation of such effects.NOTE 3 The structure of animal tissues being processed can affect the inactivation and/or elimination of transmissible agents, and the potential for retaining viable cells can be affected by the structure of the animal tissues and derivatives being processed. 4.2.1.2 What materials and/or components are incorporated in the medical device or are used with, or are in contact with, the medical device? The following factors shall be addressed, if applicable: a) if viable animal materials are utilized in the manufacture of the medical device, verification that the final medical device contains no viable animal material; b) the intended use of any animal tissue or derivative; c) geographical source, species, age and feeding (including use of animal-derived protein) of animals; d) veterinary control, conditions under which the animal materials are recovered, potential for cross-contamination; e) the type and anatomical source of tissue; f) the production process, particularly if it uses materials pooled from more than one animal; g) the nature of material utilized in the medical device, (e.g. intact tissue, highly purified derivative); h) the method of utilization or incorporation into the medical device. In the case of medical devices utilizing several relevant constituents (e.g. from various species, origin or tissues) or several similar types of constituents produced using different methods, each individual constituent should be analysed separately.4.2.1.3 Is the device supplied sterile or intended to be sterilized by the user or are other microbiological controls applicable? Given the biological nature of animal tissues or derivatives, variations in the bioburden of bacteria, mould and yeast of the animal material shall be estimated. NOTE See also ISO 1 1 737-1 and ISO 1 41 60. 4.2.1.4 Are there unwanted outputs of substances? The possible presence of toxic residue related to the manufacturing process utilized or degradation by-products shall be addressed taking into account the physical characteristics (e.g. porosity, heterogeneity) and chemical composition of animal tissues or derivatives. NOTE See also ISO 1 0993-1 , ISO 10993−9, ISO 10993−1 7, ISO 10993−1 8 and ISO 10993−1 9.ANSI AAMI ISO 22442-1 pdf download.