Standards

YY 0671.2-2011 Replaced

YY 0671.2-2011 Sleep apnoea breathing therapy—Part 2:Masks and application accessories

This part of YY 0671 applies to face masks and their fixings, as well as accessories used to connect sleep apnea treatment devices to patients. It specifies in detail the requirements for face masks and accessories, covering components used for any necessary connections, including the patient interface of sleep apnea treatment devices and parts required for patient connection, as well as components used during sleep apnea treatment, such as nasal masks, exhaust ports, and headbands.
The requirements for sleep apnea treatment devices are described in Part 1 of YY 0671. Typical components covered by the two parts of the YY 0671 standard are shown in Figure A.1.
This part does not include requirements for oral appliances.

Publish Date: 2011-12-31

YY 0793.2-2011 Replaced

YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 2:For single-bed haemodialysis

This part of YY 0793 specifies the terms and definitions, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage for water treatment equipment used in single-bed hemodialysis and related treatments (hereinafter referred to as the equipment).
This part applies to water treatment equipment for preparing water used in single-bed hemodialysis and related treatments, but not to water treatment equipment for preparing water used in multi-bed hemodialysis and related treatments. The water covered by this part includes:
a) water used for preparing dialysis concentrate;
b) water used for preparing dialysis solution;
c) water used for reuse of dialyzers.
The equipment specified in this part includes all devices, pipelines, and fittings between the connection point where municipal drinking water enters the equipment and the point where the treated water is used in the equipment. It does not include:
a) the concentrate supply system;
b) the dialysis solution regeneration system;
c) dialysis concentrate;
d) hemodialysis filtration systems;
e) blood filtration systems;
f) dialyzer reuse systems and peritoneal dialysis systems, etc.

Publish Date: 2011-12-31

YY 0827-2011 Replaced

YY 0827-2011 Medical electrical equipment—Part 2:Particular requirements for the safety of transport incubators

Addition:
This dedicated standard specifies the safety requirements for transfer incubators as defined in clause 2.1.101.
This dedicated standard does not apply to infant incubators (see GB 11243).

Publish Date: 2011-12-31

YY 0833-2011 Replaced

YY 0833-2011 Compression physiotherapy equipment for limbs

This standard specifies the terms and definitions, classification and composition, requirements, test methods, inspection rules, marking, user manuals, packaging, transportation, and storage of limb compression therapy equipment (hereinafter referred to as the equipment).
This standard applies to the equipment specified in Clause 3.1.
This standard does not apply to the following equipment:
——Hemostatic equipment;
——Anti-bedsore air cushions;
——Shock wave therapy equipment;
——Cupping jars;
——Airbag extracorporeal counterpulsation devices.

Publish Date: 2011-12-31

YY 0834-2011 Replaced

YY 0834-2011 Medical electrical equipment—Part 2-35:Particular requirements for the safety of blankets,pads and mattresses,intended for heating in medical use

This dedicated standard specifies the requirements for electric blankets, electric pads, and electric mattresses, including air cushions and inflation systems. The definitions are provided in Sections 2.2.102, 2.2.106, and 2.2.107.
The purpose of this dedicated standard is to stipulate the requirements for heating equipment and the methods of verifying compliance, with the aim of minimizing the risks to patients and operators.

Publish Date: 2011-12-31

YY 0836-2011 Replaced

YY 0836-2011 Dental handpieces—Dental low-voltage electrical motor

This standard specifies the performance requirements and test methods for low-voltage dental electric motors used on patients connected to dental handpieces, and also includes the manufacturer's user manuals, packaging, and markings. All tests in this standard are type tests.
Dental low-voltage electric motors are controlled by dental treatment units or used as independent mobile devices. They are used with dental straight handpieces and curved handpieces.
The provisions listed in this standard take precedence over the GB 9706.1—2007 standard.
Only the provisions listed in this standard are applicable.
This standard references the GB 9706.1—2007 standard. Wherever references are made, the clause numbers in the GB 9706.1—2007 standard are indicated.

Publish Date: 2011-12-31

YY 0837-2011 Replaced

YY 0837-2011 Dental handpieces—Dental air-motors

This standard specifies the performance requirements and test methods for dental pneumatic motors used on patients, which are controlled by dental treatment machines and connected to dental straight handpieces and curved handpieces.
This standard also regulates the manufacturer's user manuals, markings, and packaging.
This standard cites GB 9706.1—2007 (Safety Fundamental Standards for Medical Electrical Equipment). Wherever there are citations, the clause numbers in GB 9706.1—2007 are indicated.
The provisions specified in this standard take precedence over those in GB 9706.1—2007.
Only the provisions listed in this standard are applicable.

Publish Date: 2011-12-31

YY 0838-2011 Replaced

YY 0838-2011 Microwave ablation/coagulation equipment

This standard specifies the terms and definitions, composition and classification, requirements, test methods, inspection rules, marking, packaging, transportation, and storage of microwave coagulation equipment.
This standard applies to the requirements of microwave coagulation equipment used in medical practice as defined in Clause 3.1 (hereinafter referred to as the equipment).
For combination equipment with microwave coagulation function, the coagulation function must meet the requirements of this standard, and the physiotherapy part shall meet the requirements of GB 9706.6—2007 "Medical Electrical Equipment - Part 2: Safety Special Requirements for Microwave Therapy Equipment".

Publish Date: 2011-12-31

YY/T 0345.1-2011 Replaced

YY/T 0345.1-2011 Implants for surgery—Skeletal pins and wires—Part 1:Material and mechanical requirements

This part of YY/T 0345 specifies the material and mechanical property requirements for metal bone needles used in orthopaedic surgery, excluding metal wires used for tying and wrapping.

Publish Date: 2011-12-31

YY/T 0567.6-2011 Replaced

YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems

This part of YY/T 0567 specifies the requirements for isolator systems used in aseptic processing, and provides guidance on the identification, disinfection, validation, operation, and control of isolator systems used in the aseptic processing of medical products.
This part focuses on the use of isolator systems to maintain aseptic conditions and may include the application of hazardous raw materials.
This part does not replace or substitute for national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or simplified requirements that belong to national or regional jurisdictions.

Publish Date: 2011-12-31

YY/T 0823-2011 Replaced

YY/T 0823-2011 The fluoride compounds for dental carious prevention materials

This standard specifies the requirements and testing methods for dental fluoride anti-cavity materials.
This standard applies to dental materials that contain fluoride as an active ingredient and are used to prevent tooth decay.

Publish Date: 2011-12-31

YY/T 0773-2010 Replaced

YY/T 0773-2010 General technical requirements for ophthalmic ultrasound B-mode scan

This standard specifies the composition and basic parameters, requirements, test methods, markings, and user manuals of ophthalmic B-type ultrasound diagnostic devices.
This standard applies to ophthalmic B-type ultrasound diagnostic devices with an ultrasound operating frequency range of 10 MHz to 25 MHz (hereinafter referred to as "diagnostic devices").

Publish Date: 2010-12-27