YY 1105-2024 Pending

YY 1105-2024 Electirc apparatus for gastric lavage

This document specifies the safety and performance requirements for electric gastric lavage machines and describes the corresponding test methods.
This document is applicable to electric gastric lavage machines used for clinical gastric lavage on adult patients in medical institutions.

Publish Date: 2024-09-29

YY 0790-2024 Pending

YY 0790-2024 Hemoperfusion equipment

This document specifies the requirements for blood perfusion equipment and describes the corresponding test methods.
This document applies to the blood perfusion equipment defined in 3.1 (hereinafter referred to as the equipment).
This document does not apply to:
—— Peritoneal dialysis equipment;
—— Centrifugal blood component separation equipment;
—— Continuous blood purification equipment;
—— Plasma exchange equipment;
—— Plasma adsorption equipment;
—— Hemodialysis equipment.

Publish Date: 2024-09-29

YY 0271.2-2024 Pending

YY 0271.2-2024 Dentistry—Water-based cements—Part 2:Resin-modified cements

This document specifies the requirements for resin-modified dental adhesives used for bonding, underlayment or lining, restoration, and fabrication of dental posts and cores, and describes the corresponding test methods. This document applies to resin-modified water-based dental adhesives that are cured through a combination of various reactions, including acid-base reactions and polymerization reactions. For example, traditional polyacrylic acid-based glass ionomer dental adhesives are typically produced by the reaction of an ion-releasing aluminosilicate glass with polyacrylic acid in a water environment. The adhesives covered in this document can typically be cured either through water-based acid-base reactions or polymerization reactions. Note: Manufacturers and testing institutions should pay attention to the closely related international standards ISO 4049 (YY 1042-2023/ISO 4049:2019, MOD) and ISO 9917-1 (YY 0271.1-2016/ISO 9917-1:2007, MOD). When evaluating any specific product, the most suitable of the aforementioned standards should be considered for application.

Publish Date: 2024-09-29

YY 0580-2024 Pending

YY 0580-2024 Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filters

本文件规定了一次性使用无菌动脉管路血液过滤器(以下简称过滤器)的要求,描述了相应的试验方法。
本文件适用于心肺转流手术用过滤器,不适用于心肺转流系统的血液管路。
注:过滤器适用于进行心肺转流手术时,滤除人体血液中的各种微粒,如血块、碎屑和气栓及其他具有潜在性危险的物质。

Publish Date: 2024-07-08

YY 0117.2-2024 Pending

YY 0117.2-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 2:ZTi6Al4V titanium alloy castings

本文件规定了由ZTi6Al4V钛合金材料制造的外科植入物骨关节假体铸件的要求、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ZTi6Al4V钛合金铸件的生产和验收。

Publish Date: 2024-07-08

YY 0117.3-2024 Pending

YY 0117.3-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings

本文件规定了外科植入物用钴铬钼合金材料制造外科植入物骨关节假体铸件的要求、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钴铬钼金铸件的生产和验收。

Publish Date: 2024-07-08

YY 0329-2024 Pending

YY 0329-2024 Leukocyte reduction filters for single use

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。

Publish Date: 2024-07-08

YY 0585.4-2024 Pending

YY 0585.4-2024 Fluid lines for use with pressure infusion equipment and accessories for single use—Part 4:Check valves

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。

Publish Date: 2024-07-08

YY 0599-2024 Pending

YY 0599-2024 Laser therapeutic equipment—Excimer laser cornea ametropia equipment

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)。

Publish Date: 2024-07-08

YY 0603-2024 Pending

YY 0603-2024 Cardiopulmonary bypass systems—Hard-shell cardiotomy/venous reservoir systems(with/without filter) and soft venous reservoir bags

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。

Publish Date: 2024-07-08

YY 0789-2024 Pending

YY 0789-2024 Laser therapeutic equipment—Q-switched ophthalmic laser equipment

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)。

Publish Date: 2024-07-08

YY 0792-2024 Pending

YY 0792-2024 Ophthalmic instruments—Endoilluminators

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。

Publish Date: 2024-07-08