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The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices . [ 1 ]
Sometimes one hears of biocompatibility testing that is a large battery of in vitro test [4] that is used in accordance with ISO 10993 (or other similar standards) to determine if a certain material (or rather biomedical product) is
ISO 11866-1:2005 Part 1: Most probable number technique using 4-methylumbelliferyl-beta-D-glucuronide (MUG) ISO 11866-2:2005 Part 2: Colony-count technique at 44 degrees C using membranes; ISO 11886:2002 Building construction machinery and equipment – Pile driving and extracting equipment – Terminology and commercial specifications
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1 ISO 1 – ISO 19999. 2 ISO 20000 – ISO 99999. 3 See also. 4 Notes. 5 References. 6 External links. Toggle the table of contents. List of ISO standards. 24 ...
An SLS machine being used at the Centro de Pesquisas Renato Archer in Brazil.. Selective laser sintering (SLS) is an additive manufacturing (AM) technique that uses a laser as the power and heat source to sinter powdered material (typically nylon or polyamide), aiming the laser automatically at points in space defined by a 3D model, binding the material together to create a solid structure.
ISO 10993; ISO 13485; ISO 14971; Italian Device Registration; M. Medical Device Radiocommunications Service; Medical Device Regulation Act; Medical device reporting;
Many polycarbonate grades are used in medical applications and comply with both ISO 10993-1 and USP Class VI standards (occasionally referred to as PC-ISO). Class VI is the most stringent of the six USP ratings. These grades can be sterilized using steam at 120 °C, gamma radiation, or by the ethylene oxide (EtO) method. [20]