【CODEX】无源医疗器械产品原材料变化评价指南(3-4)
四、变更举例
IV. Examples of the Changes
医疗器械种类繁多，按照其与人体接触时间的不同，可分为短期（<24小时）、长期（>24小时<30天）及永久接触（>30天）类产品，按照其是否植入人体，可分为植入物和非植入物产品。所用材料更是多种多样，按照器械所用材料种类可分为高分子材料、金属材料、生物活性材料等，高分子材料又包括聚氯乙烯、聚氨酯、苯乙烯类热塑性弹性体等，金属材料包括不锈钢、钛合金等，甚至相同名称的材料其组分也可能各有不同，比如聚氯乙烯材料，一般由聚氯乙烯聚合物和一定比例的添加剂组成，常见的添加剂包括增塑剂、抗氧化剂、稳定剂等。同是聚氯乙烯材料，其组成组分及含量可能完全不同。
There are many types of medical devices, which can be divided into short-term (<24 hours), long-term (>24 hours <30 days) and permanent contact (>30 days) products according to their different time of contact with human body, and can be divided into implants and non-implants according to whether they are implanted into human body. The materials used are various, and can be divided into polymer materials, metal materials, bioactive materials, etc. according to the materials used in the devices. The polymer materials include polyvinyl chloride, polyurethane, styrene thermoplastic elastomers, etc., and the metal materials include stainless steel, titanium alloy, etc. Even the materials with the same name may have different components, such as polyvinyl chloride materials, generally composed of polyvinyl chloride polymer and a certain proportion of additives. Common additives include plasticizers, antioxidants, stabilizers, etc. Composition and content may be completely different for polyvinyl chloride materials, even though they share the same name.
CODEX是为数不多能够为在全球市场寻求发展的医疗企业提供跨国沟通渠道的专业服务商。CODEX团队由包括医学博士在内的高学历资深的全职员工组成，多年来深耕于医疗服务领域。CODEX拥有生命科学专业且庞大的数据库，同时CODEX医学翻译服务通过了ISO9001:2015和ISO17100:2015双重质量体系认证。在本地化、文档翻译和医学文献翻译方面，CODEX能够提供40多种语言的全方位端到端医学内容和咨询服务。
我们专注于生命科学，与客户紧密合作，为客户提供精准的医学解决方案，与客户一起顺利应对全球市场、消费者以及监管和专利环境所面临的挑战。
