Valid

YY/T 0697-2016Electric cervical and lumbar traction therapy device (English PDF)

电动颈腰椎牵引治疗设备

Preview PDF

This is a limited preview

Buy now to download the full PDF (21 pages)

Need quotation for your management?

Get a formal quotation for YY/T 0697-2016 in 30 minutes.

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.

Found what you need?

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

Similar standards

Editions of YY/T 0697

EditionTitleRevisionStatus
YY/T 0697-2016Electric cervical and lumbar traction therapy devicecurrent editionCurrent
YY 0697-2008Electric cervical and lumbar traction therapy deviceprevious editionSuperseded

This page sells the current edition, YY/T 0697-2016. Earlier editions are listed for reference only.

How to Download YY/T 0697-2016

  1. 1

    Add to cart

    Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.

  2. 2

    Checkout

    Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).

  3. 3

    Instant delivery (0–9 sec)

    Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.

  4. 4

    Invoice included

    A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.

Related Standards

English PDF
21 pages
Instant delivery (0–9 sec)
Invoice included
View Cart

Secure payment via Stripe

Payments accepted

VisaMastercardAmerican ExpressApple PayGoogle PayStripe

YY/T 0697-2016

$169.00