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YY/T 0697-2016 English PDF

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YY/T 0697-2016: Electric cervical and lumbar traction therapy device
Status: Valid

YY/T 0697: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0697-2016English219 Add to Cart 3 days [Need to translate] Electric cervical and lumbar traction therapy device Valid YY/T 0697-2016
YY 0697-2008English279 Add to Cart 3 days [Need to translate] Dynamoelectric traction-table Obsolete YY 0697-2008

PDF similar to YY/T 0697-2016


Standard similar to YY/T 0697-2016

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Basic data

Standard ID YY/T 0697-2016 (YY/T0697-2016)
Description (Translated English) Electric cervical and lumbar traction therapy device
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Word Count Estimation 11,159
Date of Issue 2016-07-29
Date of Implementation 2017-06-01
Older Standard (superseded by this standard) YY 0697-2008
Regulation (derived from) State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies) State Food and Drug Administration

YY/T 0697-2016: Electric cervical and lumbar traction therapy device

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Electric cervical and lumbar traction therapy device ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0697-2008 Electric neck and lumbar traction treatment equipment 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Requirements 1 4 Test method 4 5 logo 6 6 Packaging, transportation, storage 6 Appendix A (informative) Traction mode 7

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized. The drafting of this standard. State Food and Drug Administration Tianjin Medical Equipment Quality Supervision and Inspection Center, Jiangsu Province, medical equipment inspection Test center. The main drafters of this standard. Zhang Yun, Zhang Haiming, Qian Xuebo, Wu Gang, Qi Ruijing, Zhang Yichuan, Zhang Wei. This standard replaced the previous version of the standard release. --- YY 0697-2008. Electric neck and lumbar traction treatment equipment

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 article Pieces. 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.

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