ISO/TR 22442-4:2010 利用动物组织及其衍生物的医疗设备 第4部分：传染性海绵状脑病（TSE）试剂的消灭和/或失效的原则以及那些过程的确认试验

标准编号：ISO/TR 22442-4:2010

中文名称：利用动物组织及其衍生物的医疗设备 第4部分：传染性海绵状脑病（TSE）试剂的消灭和/或失效的原则以及那些过程的确认试验

英文名称：Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays fo

发布日期：2010-12

标准范围

ISO/TR 22442-4:2010提供了设计和进行验证分析的建议，以帮助确定从非存活动物组织中提取的医疗器械的制造过程是否有助于降低传染性海绵状脑病（TSE）的医源性传播风险。用于处理动物组织的TSE去除方法也应降低通过人类来源的非存活组织传播TSE感染的风险；本技术报告不涉及此问题。本文介绍了一些关于人类组织和TSE的最新信息，这些信息可以通过类比应用于其他动物组织。ISO/TR 22442-4:2010并不意味着需要验证涉及特定材料的方法，这些材料被确定为具有与ISO 22442-1:2007附录C中列出的TSE试剂污染的“可忽略风险”。其目的是澄清ISO 22442系列以及ISO 14160中包含的国际标准最终草案。ISO/TR 22442-4:2010以ISO 22442-3中有关TSE试剂的具体讨论为基础，并试图总结消除TSE试剂领域的当前技术状态。随着对TSE试剂失活和消除的理解不断发展，本文件将在可能的情况下进行修订。

ISO/TR 22442-4:2010 offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs).The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues.ISO/TR 22442-4:2010 does not intend to imply a need for validation of methods involving specific materials identified as having a "negligible risk" of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007.It is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160.ISO/TR 22442-4:2010 builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.

标准预览图