【CODEX翻译】YY 0465-2019 一次性使用空心纤维血浆分离器和血浆成分分离器-中英双语
发布日期：2021-11-05
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【CODEX翻译】YY 0465-2019 一次性使用空心纤维血浆分离器和血浆成分分离器
一次性使用空心纤维血浆分离器和血浆成分分离器
Disposable Membrane Plasmaseparator and Plasma Component Separator
1 范围
1 Scope
本标准规定了一次性使用空心纤维血浆分离器和血浆成分分离器的术语和定义型式和型号命名要求试验方法检验规则标志及包装运输贮存。
In this standard the terminology and definitions, type and model naming, requirements, test methods, the inspection criterion, marking and packaging, transportation and storage of the disposable membrane plasmaseparator and plasma component separator are described.
本标准适用于一次性使用空心纤维血浆分离器和血浆成分分离器。一次性使用空心纤维血浆分离器（简称血浆分离器）配合血浆分离装置对各种免疫、代谢失调及某些中毒等疾病进行治疗。一次性使用空心纤维血浆成分分离器（简称血浆成分分离器）适用于实施双重滤过血浆交换治疗，与血浆分离器联用、通过膜分离方法，从分离出来的血浆中再分离一定相对分子质量的物质。
The standard applied to disposable membrane plasmaseparator and plasma component separator. The disposable membrane plasmaseparator (hereinafter referred to as plasmaseparator) is used to treat critical patients with immune disorder, metabolic disorder and poisoning in conjunction with the plasma separation unit. The disposable membrane plasma component separator (hereinafter referred to as plasma component separator) applied to dual-filtration plasma exchange treatment in conjunction with the plasmaseparator, i.e. separate a certain molecular weight of substance from the separated plasma.
2 规范性引用文件
2 Normative references
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新本（包括所有的修改单）适用于本文件。
The following documents play an essential role in the application of this document. For all dated references, only the dated edition is applicable to this document. For all undated references, the latest edition (including all amendments) is applicable to this document.
GB/T 191包装储运图示标志
GB/T 191 Packaging--Pictorial markings for handling of goods
GB/T 1962.2 注射器、注射针及其他医疗器械6%（鲁尔）圆锥接头 第2部分：锁定接头
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
GB/T 13074血液净化术语
GB/T 13074 Terms of Blood Purification
GB/T 14233.1—2008 医用输液，输血、注射器具检验方法 第1部分：化学分析方法
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use Part 1: Chemical analysis methods
GB/T 16886.1 医疗器械生物学评价 第1部分：风险管理过程中的评价与试验
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.4 医疗器械生物学评价 第4部分：与血液相互作用试验选择
GB/T 16886.4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.5 医疗器械生物学评价 第5部分：体外细胞毒性试验
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10 医疗器械生物学评价 第10部分：刺激与皮肤致敏试验
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
GB/T 16886.11医疗器械生物学评价第11部分：全身毒性试验
GB/T 16886.11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分：通用要求
YY/T 0466.1 Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements
中华人民共和国药典（2015年版）
Chinese Pharmacopoeia, 2015 Edition
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CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.
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