Current Category: CN-YY - Medicine
本文件规定了一次性使用去白细胞滤器的分类与命名、材料、要求、标志和包装，描述了相应的试验方法。
本文件适用于一次性使用去白细胞滤器(以下简称“去白细胞滤器”)。
注：去白细胞滤器可与输血器、采血/血液成分分离系统连接，用于去除血液及血液成分中的白细胞。
本文件规定了一次性使用重力输液和/或压力输液式输液器具用防回流阀的性能要求。
本文件适用于一次性使用重力输液和/或压力输液式输液器具用防回流阀，基本要求还适用于内置防回流阀。
本文件规定了准分子激光角膜屈光治疗机的要求，描述了相应的试验方法。
本文件适用于准分子激光角膜屈光治疗机（以下简称治疗机）。
本文件规定了无菌、一次性使用的体外循环心脏手术硬壳贮血器、硬壳静脉贮血器系统（带或不带过滤器）和静脉贮血软袋（简称贮血器）的要求，描述了相应的试验方法。贮血器拟供进行心肺转流手术（CPB）时贮血使用。本文件仅适用于多功能系统的贮血器，该系统可能有整体化部件，如血气交换器（氧合器），血液过滤器，祛泡器，血泵等。
本文件规定了调Q眼科激光治疗机的产品分类、要求，描述了相应的试验方法。
本文件适用于调Q眼科激光治疗机（以下简称治疗机）。
本文件规定了在眼科手术中,用于眼内照明的眼内照明器光源和眼内照明器光导的通用要求、光辐射安全要求并描述了相应的试验方法。
本文件适用于在眼科手术中,用于眼内照明的眼内照明器光源和眼内照明器光导。
本文件规定了眼用粘弹剂的预期性能、设计属性、设计评价、灭菌、产品稳定性、输送系统的完整性及性能、包装和制造商提供的信息。本文件适用于眼用粘弹剂（以下简称“粘弹剂”)。
本文件规定了用外科植入物Ti6Al4V钛合金加工材制造外科植入物骨关节假体锻件的要求、试验方法、检验规则、质量证明、标记、包装、运输和贮存。
本文件适用于骨关节假体Ti6Al4V钛合金锻件的生产和验收。
This document describes the method of measuring the acoustic field generated by medical ultrasound equipment in liquids using a calibrated hydrophone, including the requirements for the bandwidth standard and calibration frequency range depending on the spectral components of the acoustic field to be characterized.
This document:
——Provides a set of measurable acoustic parameters based on acoustic fundamentals;
——Provides a set of derived auxiliary acoustic parameters, called derived acoustic parameters, under certain assumptions of these measurements;
——Provides measurement steps that can be used to determine acoustic pressure parameters;
——Provides conditions for measuring acoustic parameters using a calibrated hydrophone;
——Provides steps to correct the limitations caused by using hydrophones with limited bandwidth and limited sensitive element sizes, and is used to estimate the corresponding uncertainties.
This document is applicable to the measurement and characterization of medical ultrasound fields using ultrasonic hydrophones.
This document specifies the dimensions of small-bore connectors, as well as the requirements for their design and functional characteristics, which are intended for use in medical devices and accessories for intravascular applications or subcutaneous injection connections in medical devices and accessories.
Example: Subcutaneous syringes and injection needles or intravascular (IV) catheters with male and female luer non-locking (sliding) connectors and luer locking connectors.
Note 1: See Appendix A.
Note 2: Luer connectors were originally designed for pressures not exceeding 300 kPa.
This document does not specify the requirements for medical devices or accessories that use these connectors. These requirements are given in the dedicated documents for specific medical devices or accessories.
This document does not specify the requirements for small-bore connectors specified in the following other documents:
—— Blood dialyzers, blood dialysis filters, and blood filter blood chamber interfaces (applicable parts of ISO 8637 and ISO 8638 related to blood chamber interfaces);
—— Connectors for blood dialysis, blood dialysis filtration, and blood filtration equipment (ISO 8637);
—— Bottle cap penetration connectors for infusion systems (ISO 85364).
Note 3: Even if the current dedicated documents related to medical devices do not make requirements, manufacturers are encouraged to apply small-bore connectors that comply with this document to medical devices or accessories. It is expected that when the relevant dedicated medical device documents are revised, the requirements for small-bore connectors specified in YY/T 0916 will be included therein.
Note 4: Chapter 7 of YY/T 0916.1—2021 specifies alternative methods for small-bore connectors that comply with YY/T 0916.1—2021 but do not comply with this document, which are intended for use in medical devices or accessories for intravascular applications or subcutaneou
本文件适用于由化学成分符合GB/T 13810或ISO 5832-2、ISO 5832-3、ISO 5832-11或ASTM F67、ASTM F136、ASTM F1295、ASTM F1472中外科植入物用钛及钛合金材料制成的牙种植体。
本文件不适用于牙种植体附件和增材制造钛及钛合金牙种植体。
本文件规定了医用外科口罩的技术要求、试验方法、标志、包装、运输和贮存。本文件适用于医护人员在含有潜在血液、体液、分泌物污染风险的医疗环境及有创操作环境佩戴的一次性医用口罩。本文件不适用于医用及其他工作环境下的防护口罩。