Standards

YY 0635.1-2008 Replaced

YY 0635.1-2008 Inhalational anaesthesia systems—Part 1:Anaesthetic breathing system for adults

This part of YY 0635 specifies the dedicated requirements for inhalation anesthesia breathing systems intended for adults, which are provided or assembled by manufacturers, or assembled by users under the guidance of manufacturers. This standard also includes requirements for circulating absorption components, exhaust valves, inhalation and exhalation valves, and components of anesthesia breathing systems that make up anesthesia workstations in some designs, including the exhalation gas channels of anesthesia ventilators and any parts of the anesthesia gas purification system (AGSS) that can be disassembled by non-operators.

Publish Date: 2008-04-25

YY 0636.1-2008 Replaced

YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements

This part of YY 0636 specifies the minimum safety and performance requirements for medical and surgical suction devices (see Figure 1). These suction devices can be used in hospitals and other health institutions, for patient home care, and in field and transportation situations.

Publish Date: 2008-04-25

YY 0636.2-2008 Replaced

YY 0636.2-2008 Medical suction equipment—Part 2:Manually powered suction equipment

This part of YY 0636 specifies the safety and performance requirements for manually operated suction devices used for pharyngeal suction. It includes suction devices operated by foot pedal, manual operation, or a combination of both (see Figure 1). The scope of this part of YY 0636 includes non-electric suction devices that can be combined with electrical equipment.

Publish Date: 2008-04-25

YY 0636.3-2008 Replaced

YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source

This part of YY 0636 specifies the safety and performance requirements for medical suction devices powered by negative pressure or pressure sources (see Figure 1). It is particularly suitable for pipe connections and Venturi tube add-on devices. Suction devices containing electrical control elements (such as electronic timers) should also comply with the requirements of GB 9706.1—2007.

Publish Date: 2008-04-25

YY 0637-2008 Replaced

YY 0637-2008 Medical electrical equipment—Requirement for the safety of radiotherapy treatment planning system

This standard applies to the design, manufacture, installation, and use of radiation therapy planning systems (hereinafter referred to as RTPS);
——Applied in medical settings for formulating radiation therapy plans;
——The input data can either be entered by the operator or obtained directly from other devices;

Publish Date: 2008-04-25

YY 0645-2008 Replaced

YY 0645-2008 Continuous blood purification equipment

This standard specifies the terms and definitions, classification and marking, requirements, test methods, labels, user manuals, and packaging, transportation, and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as the equipment). The equipment does not include replacement fluid or dialysis fluid preparation systems and can be used for continuous blood purification treatments such as blood filtration for more than 24 hours.

Publish Date: 2008-04-25

YY 0646-2008 Replaced

YY 0646-2008 Small steam sterilizers—Automatic type

This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers. This standard applies to electrically heated or externally connected steam-generating automatic control type small steam sterilizers with a sterilization chamber volume not exceeding 60 L, which cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm). This type of sterilizer is mainly used for sterilizing medical supplies or materials and instruments that may come into contact with blood or body fluids. This standard does not apply to the sterilization of sealed liquids. This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.

Publish Date: 2008-04-25

YY 0647-2008 Replaced

YY 0647-2008 Non-active surgical implants—Mammary implants—Particular requirements

This standard specifies the special requirements for breast implants (also known as breast prostheses, breast implants, and artificial breasts, hereinafter referred to as implants) intended for clinical use. This standard provides specific descriptions of the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer. At the same time, it takes into account the safety factors of the implants.

Publish Date: 2008-04-25

YY 0649-2008 Replaced

YY 0649-2008 High electrical potential therapy equipment

This standard specifies the terms and definitions, requirements, test methods, inspection rules, and markings, packaging, transportation, and storage of high-potential therapy equipment. This standard applies to the high-potential therapy equipment specified in Clause 3.1 (hereinafter referred to as the equipment).

Publish Date: 2008-04-25

YY 1070-2008 Replaced

YY 1070-2008 Dental baseplate/modelling wax

This standard specifies the classification and requirements for dental base/model waxes, which are mainly used in the fabrication of dentures and are composed of natural waxes and synthetic waxes. It also stipulates the corresponding test methods to determine whether the tested samples meet the requirements of this standard.

Publish Date: 2008-04-25

YY/T 0316-2008 Replaced

YY/T 0316-2008 Medical devices—Application of risk management to medical devices

This standard specifies a process for manufacturers to identify hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of this standard apply to all stages of the life cycle of medical devices. This standard is not intended for clinical decision-making. This standard does not specify acceptable risk levels. This standard does not require manufacturers to have an appropriate quality system. However, risk management can be an integral part of the quality management system.

Publish Date: 2008-04-25

YY/T 0606.7-2008 Replaced

YY/T 0606.7-2008 Tissue engineered medical products—Part 7:Chitosan

This part of YY/T 0606 specifies the requirements for chitosan raw materials used in the preparation of tissue engineering medical products, including testing methods, inspection rules, marking, packaging, transportation, and storage requirements.
This part is applicable to chitosan and its salts, which can be used in the preparation of tissue engineering medical products.

Publish Date: 2008-04-25