Standards

YY/T 1411-2016 Replaced

YY/T 1411-2016 Dentistry—Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water

This standard provides guidance on the methods of type testing. These testing methods are used to evaluate the effectiveness of treatment measures to improve or maintain the microbiological quality of water used for dental treatment in laboratory conditions, as well as other dental equipment.
This standard does not set limits for the corresponding microbiological indicators. The methods described are not applicable to clinical conditions.

Publish Date: 2016-03-23

YY 0325-2016 Replaced

YY 0325-2016 Sterile urethral catheter for single use

This standard specifies the terms and definitions, requirements, symbols and marks, packaging, etc. of disposable sterile urinary catheters.
This standard applies to disposable sterilized urinary catheters with and without balloons.

Publish Date: 2016-03-23

YY 0503-2016 Replaced

YY 0503-2016 Ethylene oxide sterilizer

This standard specifies the terms and definitions, classification and marking, requirements, test methods, inspection rules, marking, user manuals, and packaging, transportation, and storage of ethylene oxide sterilizers. This standard applies to ethylene oxide sterilizers (hereinafter referred to as sterilizers) that use ethylene oxide liquefied gas for sterilization and have a maximum working pressure of less than 100 kPa. These sterilizers are used for industrial production sterilization and medical sterilization. Note: Unless otherwise specified, the pressures referred to in this standard are all relative pressures. The content of this standard includes minimum performance and structural requirements for operating the sterilizer above or below atmospheric pressure: - Ensuring that the sterilization process can be used to sterilize the items to be sterilized; - Equipment and control devices necessary for implementing and monitoring the sterilization process. This standard does not specify the packaging requirements for finally sterilized medical devices. For related requirements, please refer to GB/T 19633. This standard does not specify whether medical device materials are suitable for ethylene oxide sterilization. For related requirements, please refer to YY/T 1267. This standard does not specify requirements for sterilization validation and routine control. For related requirements, please refer to GB 18279. This standard does not discuss the residual amount of ethylene oxide in medical devices. Note: For certain medical device products, the national and industry standards specify the allowable residual amount of ethylene oxide, and these requirements should be followed accordingly.

Publish Date: 2016-03-23

YY 1282-2016 Replaced

YY 1282-2016 Intravenous catheter for single use

This standard specifies the requirements for single-use venous indwelling needles (hereinafter referred to as "indwelling needles") used for infusion or blood transfusion into the peripheral venous system of the human body, to ensure their compatibility with corresponding infusion and transfusion devices.
This standard applies to indwelling needles used for infusion or blood transfusion into the peripheral venous system of the human body.

Publish Date: 2016-03-23

YY 1300-2016 Replaced

YY 1300-2016 Therapeutic laser equipment—Pulsed Nd:YAG laser equipment for therapy

This standard specifies the terms and definitions, basic parameters, requirements, test methods, sampling and marking, labeling, packaging, and other requirements for pulsed neodymium-doped yttrium aluminum garnet (Nd:YAG) laser therapy machines.
This standard applies to free-oscillating pulsed neodymium-doped yttrium aluminum garnet laser therapy machines with a wavelength of 1,064 nm (hereinafter referred to as therapy machines). The therapy machines can coagulate, vaporize, carbonize, and melt biological tissues.
This standard does not apply to Q-switched neodymium-doped yttrium aluminum garnet laser therapy machines.

Publish Date: 2016-03-23

YY 0299-2016 Replaced

YY 0299-2016 Medical ultrasonic couplants

This standard specifies the definition, classification, requirements, test methods, inspection rules, and packaging, marking, transportation, and storage of medical ultrasound coupling agents.
This standard applies to medical ultrasound coupling agent products (hereinafter referred to as "products"), including those manufactured and sold by enterprises as commodities, as well as those self-made and self-used by medical institutions. This product is used as a sound-transmitting medium between the probe and the treatment head and human tissue in ultrasound diagnosis and treatment operations.

Publish Date: 2016-01-26

YY 0579-2016 Replaced

YY 0579-2016 Ophthalmic instruments—Ophthalmometers

This standard, together with ISO 15004-1:2006, specifies the requirements and test methods for continuous or digital corneal curvature meters. Some corneal curvature meters (Type 1 in Table 1) can measure the radius of curvature of contact lenses, assuming that the front surface of the cornea and the surface of the contact lens are spherical or toric.
In the event of discrepancies, this standard takes precedence over ISO 15004-1:2006.

Publish Date: 2016-01-26

YY 1475-2016 Replaced

YY 1475-2016 Laser therapeutic equipment—Q-Switched Nd:YAG laser equipment

This standard specifies the basic parameters, product composition, technical requirements, test methods, and requirements for marking labels and packaging of Q-switched neodymium-yttrium aluminum garnet laser treatment machines.
This standard applies to Q-switched neodymium-yttrium aluminum garnet laser treatment machines (hereinafter referred to as treatment machines) with a wavelength of 1,064 nm or a frequency-doubled wavelength of 532 nm (using Q-switched technology). These treatment machines use the selective absorption mechanism of lasers by biological tissues to achieve the therapeutic effect through micro-blasting.

Publish Date: 2016-01-26

YY/T 0486-2016 Replaced

YY/T 0486-2016 Tracheal tubes designed for laser surgery—Requirements for marking and accompanying information

This standard specifies the requirements for marking, labeling, and manufacturer's information for endotracheal tubes with and without cuffs designed to resist laser ignition, as well as related materials.

Publish Date: 2016-01-26

YY/T 0506.2-2016 Replaced

YY/T 0506.2-2016 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 2:Performance requirements and test methods

This part of YY/T 0506 specifies the performance requirements and test methods for surgical drapes, surgical gowns, and cleanroom garments.

Publish Date: 2016-01-26

YY/T 1437-2016 Replaced

YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971

When implementing risk management, this standard provides guidance for specific areas described in YY/T 0316.
This standard aims to help manufacturers and other users of the standard:
——Understand the role of product safety standards and process standards in risk management;
——Establish guidelines for determining risk acceptability criteria;
——Include production and post-production feedback loops (information, cycles, processes) in risk management;
——Distinguish between "safety information" and "disclosure of residual risks"; and
——Evaluate the comprehensive residual risk.

Publish Date: 2016-01-26

YY/T 1464-2016 Replaced

YY/T 1464-2016 Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices

1.1 Applicability
1.1.1 This standard specifies the requirements for the development, validation, and routine control of the low-temperature steam formaldehyde sterilization process for medical devices.
Note: Although the scope of this standard is limited to medical devices, the requirements specified and the guidance provided in it can be applied to other products and equipment.

Publish Date: 2016-01-26