YY/T 0697-2016Electric cervical and lumbar traction therapy device (English PDF)
电动颈腰椎牵引治疗设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 0697-2016 is the English-translated version of 电动颈腰椎牵引治疗设备.
YY/T 0697-2016 is the Chinese pharmaceutical industry standard for powered cervical and lumbar traction therapy equipment, the machines that pull to widen the intervertebral space in the treatment of spinal disease.
It sets the requirements, the test methods, the marking and the rules for packaging, transport and storage, covering the traction force and its accuracy and stability, the rate of application and release, the timer and the intermittent modes, the emergency release for the patient, the mechanical strength of the couch and the harnesses, and the electrical safety.
It does not apply to skeletal traction with pins or to rapid-thrust devices. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 0697-2016
National Standard of the People's Republic of China
- Classification
- C 42
- Replacing
- YY 0697-2008
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Requirements
- 4 Test method
- 5 logo
- 6 Packaging, transportation, storage
- Appendix A (informative) Traction mode
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0697-2008 "electric traction bed", compared with YY 0697-2008, in addition to editorial modification of the main technical changes As follows.
--- increase the traction mode requirements (3.2);
--- increase traction output requirements (3.3.1,3.3.3 ~ 3.3.7);
- Increased timing accuracy requirements (3.4) for progressive and receding periods;
- refinement of emergency protection measures (3.5);
--- delete fast pull function;
--- increase the medical electrical system safety requirements and electromagnetic compatibility requirements.
1 Scope
This standard specifies the requirements, test methods, marking, and packaging, transportation and storage of electric neck and lumbar traction therapy equipment.
This standard applies to electric drive through the traction to increase the cervical and lumbar intervertebral space for the treatment of cervical spondylosis equipment (hereinafter referred to as equipment).
This standard does not apply to the use of bone needles and other use of bone traction equipment and fast pull equipment.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191-2008 Packaging and storage icon (ISO 780.:1997, MOD)
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988 A1..1991 A2. 1995, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety (IEC 60601-1-1.:2000, IDT)
Environmental requirements and test methods for medical appliances GB/T 14710-2009 Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1.:2007, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.:2004, IDT)
YJ/T 1491-2016 Electric cervical and lumbar traction beds, chairs and accessories
3 Request
3.1 Working conditions
Shall comply with the manufacturer's regulations. If not specified, shall comply with the requirements of Chapter 10 of GB 9706.1-2007.
3.2 Traction mode
3.2.1 Built-in mode
The traction mode should be in accordance with the manufacturer's regulations. The device can be built with one or more traction modes, each of which typically includes the following Several stages (the schematic diagram of the common traction mode and the stages included in Appendix A).
a) progressive period;
b) traction phase;
c) intermittent phase (including intermittent retrogression and intermittent progressive), if applicable; d) Fade.
Traction mode can only be selected from the standby state, should not be able to switch in the course of treatment. Cervical traction should be independent of the lumbar spine Traction.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2008Graphical symbols marking for handling and storage of packages
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- YY 0505-2012Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Similar standards
Editions of YY/T 0697
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0697-2016 | Electric cervical and lumbar traction therapy device | current edition | Current |
| YY 0697-2008 | Electric cervical and lumbar traction therapy device | previous edition | Superseded |
This page sells the current edition, YY/T 0697-2016. Earlier editions are listed for reference only.
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Related Standards
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
YY 0505-2012 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 0697-2016
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