Standards

YY 0862-2011 Optics of ophthalmology, intraocular fillers

Publish Date: 2011-12-31

YY/T 0278-2011 Dental filling instrument

Publish Date: 2011-12-31

YY/T 0844-2011 Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument

This standard specifies the basic parameters, product composition, technical requirements, test methods, and marking labels, packaging, etc. of pulsed carbon dioxide laser therapy machines. This standard provides technical specifications for manufacturers of pulsed carbon dioxide laser therapy machines to formulate medical device registration product standards.
This standard applies to pulsed carbon dioxide laser therapy machines that only contain a pulsed operation mode and to the pulsed operation parts of carbon dioxide laser therapy machines that simultaneously contain a continuous wave operation mode and a pulsed operation mode (hereinafter referred to as "therapy machines"). In this standard, "pulse" refers to a pulse duration (pulse width) of less than 0.25 s. The therapy machines achieve the purpose of treatment by vaporizing, carbonizing, coagulating, and irradiating human tissues with pulsed lasers of a wavelength of 10.6 μm.
For carbon dioxide laser therapy machines that simultaneously contain a continuous wave operation mode and a pulsed operation mode, the continuous wave operation parts of these machines shall comply with GB 11748, and the pulsed operation parts of these machines shall comply with this standard.

Publish Date: 2011-12-31

YY 0290.9-2010 Ophthalmic implants—Intraocular lenses—Part 9:Multifocal intraocular lenses

This part of YY 0290 applies to intraocular lenses that provide two or more rotationally symmetric optical powers in the optical zone, as well as intraocular lenses that provide additional useful vision at a distance (both near and far) and are primarily intended to correct the vision of an aphakic eye.

Publish Date: 2010-12-27

YY 0782-2010 Medical electrical equipment—Part 2-51:Particular requirements for safety,including essential performance,of recording and analysing single channel and multichannel of electrocardiographs

Except for the following content, this chapter applies to the general standard.
Addition:
This dedicated standard specifies the safety requirements and basic performance requirements for recording and analysis single-channel and multi-channel electrocardiographs. Single-channel and multi-channel electrocardiographs have been defined in 2.101, 2.111, 2.117, 2.123, and 2.126, hereinafter referred to as devices. Such devices may be attended or unattended.
This dedicated standard supplements GB 10793—2000.

Publish Date: 2010-12-27

YY/T 0809.8-2010 Implants for surgery—Partial and total hip joint prostheses—Part 8:Endurance performance of stemmed femoral components with application of torsion

This part of YY/T 0809 specifies the fatigue performance of hip joint prostheses with a handle femoral component under specific test conditions when subjected to torque action.

Publish Date: 2010-12-27

YY/T 0708-2009 Medical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems

This parallel standard applies to the safety requirements of medical electrical equipment and medical electrical systems equipped with programmable electronic subsystems (PESS), hereinafter referred to as programmable medical electrical systems (PEMS).
Note: Some systems with software used for medical purposes are beyond the scope of this parallel standard, such as many medical information systems. The identification elements (criteria) are: whether the system meets the definition of medical electrical equipment in GB 9706.1—2007 section 2.2.15, or the definition of medical electrical systems in GB 9706.15—2008 section 2.201.

Publish Date: 2009-11-15

YY 0635.4-2009 Inhalational anaesthesia systems—Part 4:Requirements for anaesthetic ventilators

Except for the following parts, Chapter 1 of GB 9706.1—2007 applies.
This part of YY0635 is a dedicated standard based on GB 9706.1—2007. As stated in 1.3 of GB 9706.1—2007, the requirements of this part are more stringent than the corresponding requirements of GB 9706.1. If it is stated in this part that the clauses of GB 9706.1—2007 apply, it means that these clauses only apply when the requirements proposed are related to the anesthesia ventilator under consideration.
This part specifies the dedicated requirements for the basic performance of anesthesia ventilators (see the definition in 2.1). The anesthesia ventilators referred to in this part are usually components of an anesthesia system and are continuously operated with the intervention of an operator.
Anesthesia ventilators used with flammable anesthesia equipment, as determined in Appendix BB, are outside the scope of application of this part.

Publish Date: 2009-06-16

YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute systemic toxicity:intravenous path

This part of YY/T 0127 specifies the test method for acute systemic toxicity of oral medical devices via the intravenous route. This part is applicable to the evaluation of acute systemic toxicity of oral medical devices intended to come into contact with blood.

Publish Date: 2009-06-16

YY/T 0728-2009 Implants for surgery—Usage of the terms “valgus” and “varus” in orthopaedic surgery

This standard provides the current usage of the terms "valgus" and "varus" in orthopedic surgery, and describes their special applications, making them easy to understand and reducing confusion.

Publish Date: 2009-06-16

YY/Z 0719.4-2009 Ophthalmic Optics Contact Lens Care Products Part 4: Guidelines for Antimicrobial Preservative Efficacy Testing and Determination of Disposable Date

Publish Date: 2009-06-16

YY 0635.2-2009 Inhalational anaesthesia systems—Part 2:Anaesthetic gas scavenging systems transfer and receiving systems

This part of YY 0635 specifies the requirements for the transfer and collection systems of active anesthetic gas purification systems (active AGSS). It also specifies the requirements for anesthetic gas purification systems (AGSS) that combine the collection system with the processing system.
This part does not apply to passive anesthetic gas purification systems (passive AGSS) or similar gas absorption systems.
This part does not include the requirements for the following two parts:
a) Separate processing systems;
b) Installation of fixed processing systems.
This part of YY 0635 does not specify the connections between the exhaust ports of gas monitors and anesthetic gas purification systems (AGSS); the requirements for such connections are currently under consideration.

Publish Date: 2009-06-16