Current Category: CN-YY - Medicine
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