ISO/IEC 17025 认可证书 CNAS-PD19/06-A/3
Item/Parameter № Test Object Low frequency electron pulse therapeutic meter № Item/ Parameter Code of Field Title, Code of Standard or Method YY/T0696-2008Testing for nerve and muscle stimulators output characteristic YY0684-2008Neurosurgery embedded object Embedded nerve stimulators mark and packing GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety Limitation Note 12 All items 433 13 Dental comprehensive treatment device YY1043-2004 Dental comprehensive treatment device All items 433 YY/T 0629-2008Dental equipment High and middle capacity suction system YY/T 0630-2008Dentistry dental therapy device part 2: water supply and gas supply YY/T 1045.1-2009Dental handset part 1:High speed gas turbine handset GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB9706.7-2008 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment YY 0109-2003Ultrasonic atomizer GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety YY 91044-1999High-speed dental air turbine unit YY/T1147-2004General specification for eletromotion tooth drill GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB9706.10-1997 Medical electrical equipment Part ：Particular requirements for the safety of therapeutic X-ray generators 14 Ultrasonic atomizer All items 433 15 Eletromotion tooth drill All items 16 Therapeutic X-ray equipment All items 433 No. CNAS L0201 第 21 页 共 33 页
The scope of the accreditation in Chinese remains the definitive version.
ISO/IEC 17025 认可证书 CNAS-PD19/06-A/3
Item/Parameter № Test Object № Item/ Parameter Code of Field Title, Code of Standard or Method GB9706.11-1997 Medical electrical equipment Part 2：Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis GB9706.12-1997 Medical electrical equipment Part 1：General requirements for safety 3.Collateral standard：General requirements for radiation protection in diagnostic X-ray equipment GB9706.14-1997 Medical electrical equipment—Part 2：Particular requirements for the safety of associated equipment of X-ray equipment GB9706.15-2008Medical electrical equipment Part 1：General requirements for safety 1.Collateral standard ：Safety requirements for medical electrical systems YY0317-2007 General specifications for medical therapeutic X-ray equipment GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB9706.3-2000 Medical electrical equipment—Part 2 Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators GB9706.10-1997 Medical electrical equipment Part ：Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators Limitation Note 16 Therapeutic X-ray equipment All items 433 17 X-ray shaped beam surgery All items 433 No. CNAS L0201 第 22 页 共 33 页
The scope of the accreditation in Chinese remains the definitive version.
ISO/IEC 17025 认可证书 CNAS-PD19/06-A/3
Item/Parameter № Test Object № Item/ Parameter Code of Field Title, Code of Standard or Method GB9706.11-1997 Medical electrical equipment Part 2：Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis GB9706.12-1997 Medical electrical equipment Part 1：General requirements for safety 3.Collateral standard：General requirements for radiation protection in diagnostic X-ray equipment GB9706.14-1997 Medical electrical equipment—Part 2：Particular requirements for the safety of associated equipment of X-ray equipment GB9706.15-2008Medical electrical equipment Part 1：General requirements for safety 1.Collateral standard ：Safety requirements for medical electrical systems GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB 9706.5-2008 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV GB15213-1994 Medical electron accelerators-Functional characteristics and test methods GB/T 19046-2003Medical electron accelerators Acceptance and perioidc tests Limitation Note 17 X-ray shaped beam surgery All items 433 18 Medical electron accelerators part items 433 Except for:neutron radiology test Except for:neutron radiology test Except for:Oxygen penetration 19 Quick hot compress Part items YY0060-1991 Quick hot compress No. CNAS L0201 第 23 页 共 33 页
The scope of the accreditation in Chinese remains the definitive version.
ISO/IEC 17025 认可证书 CNAS-PD19/06-A/3
Item/Parameter № Test Object Magnetic hygienical cup Electrothermal constant temperature incubator Electrothermal boil sterilizer Automatic controlled pressure steam sterilizer Pre-vacuum pressure steam sterilizer № Item/ Parameter All items Code of Field 433 Title, Code of Standard or Method Limitation Note 20 YY0097-1992 Magnetic hygienical cup GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety YY0027-1990 Electrothermal constant temperature incubator 21 All items 433 22 All items 433 GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety GB8599-2008 Technical requirements for large steam sterilizers - Automatic type GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety YY0085.2-1992 Pre-vacuum pressure steam sterilizer GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety 23 All items 433 24 All items 433 25 Pressure steam sterilize (horizontal) All items 433 YY91009-1999 Pressure steam sterilize (horizontal rectangle) YY 0731-2009Large manually-controlled steam sterilizer YY1007-2005 Pressure steam sterilize (vertical) 26 Pressure steam sterilize (vertical) Pressure steam sterilize (portable) all items 433 GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety YY0504-2005 Pressure steam sterilize (portable) 27 ALL items GB9706.1-2007 Medical electrical equipment –Part 1：General requirements for safety No. CNAS L0201 第 24 页 共 33 页
The scope of the accreditation in Chinese remains the definitive version.
