Valid

YY 0570-2013Medical electrical equipment - Part 2: Particular requirements for the safety of operating tables (English PDF)

医用电气设备 第2部分:手术台安全专用要求

Preview PDF

This is a limited preview

Buy now to download the full PDF (18 pages)

Need quotation for your management?

Get a formal quotation for YY 0570-2013 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 21, 2013

Implementation date

October 1, 2014

Scope

YY 0570-2013 is the English-translated version of 医用电气设备 第2部分:手术台安全专用要求.

YY 0570-2013 is the Chinese pharmaceutical industry standard for the safety of the operating table, applying together with the general standard for medical electrical equipment, whose clauses it modifies one by one.

It covers the table whether or not it has electrical parts, including the transmission mechanism it defines and the tops that can be removed from the base, and it sets the requirements for the mechanical strength and stability of the table, the moving parts and the crushing hazards they present, the load it must carry, the controls and the protection against unintended movement, and the electrical safety. Issued on 21 October 2013, it has applied since 1 October 2014.

Found what you need?

Document preview — YY 0570-2013

National Standard of the People's Republic of China

ICS
11.040.99
Classification
C 46
Replacing
YY 0570-2005

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface The first chapter Overview
  • 1. Scope and purpose
  • 2 Terms and definitions
  • 4 2 General test requirements
  • 5 * Category
  • 6 Identification, marking and documents
  • 17 isolation (original title. insulation and protective impedance)
  • 18 protective earthing, functional earthing and potential equalization
  • 19 Continuous leakage currents and patient auxiliary current
  • 20 Dielectric strength
  • 21 Mechanical strength
  • 22 moving parts
  • 29 X-ray radiation
  • 36 Electromagnetic Compatibility
  • 44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility
  • 49 power supply interruption
  • 7 accuracy and prevent the risk of output data of the eighth chapter of the work
  • 7 50 Operating data accuracy Chapter 9. abnormal operation and fault conditions; environmental testing
  • 56 components and subassemblies
  • 101 Potential equalization connection Figure
  • Annex L (informative) Reference Standard --- publications mentioned in this standard
  • Annex AA (informative) Chapter 5, some types of applications based on the operating table of the total classification guidelines and preparation instructions

Foreword

Medical electrical equipment standard series of standards, the series standard consists of two parts.

--- Part 1. General requirements for safety of medical electrical equipment;

--- Part 2. Medical electrical equipment requirements for the safety.

This special standard for medical electrical equipment - Part 2. The safety requirements for operating tables. This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions.

This dedicated drafting standards in accordance with GB/T 1.1-2009 given rules.

The specific standard replaces YY 0570-2005 "Medical electrical equipment - Part 2. Safety requirements for operating tables." The specific standard Compared with YY 0570-2005 modified as follows.

--- Removed YY 0570-2005 with GB 9706.1-2007 duplicate content.

The use of specific standard translation method is equivalent to using the international standard IEC 60601-2-46:1998 "Medical electrical equipment - Part 2-46. Hand Operating table for the safety requirements "(in English). The specific standard IEC 60601-2-46:1998 made the following editorial changes.

--- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;

--- The standard auxiliary translation and GB 9706.1-2007 consistent.

The specific standard is based on GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (General Standard) spot Standard, and supporting the use of GB 9706.1-2007.

1 Scope and purpose

Except for the following part of this chapter apply to the General Standard.

1.1 Scope

Addition.

This standard specifies the special safety requirements 2.12.101 defined operating table. Regardless of whether this operating table electrical component, comprising Gearing 2.12.104 definition. Taiwan surface such transmissions for operating table tops with removable bottom for the operating table (or Base) drive. The specific standard does not apply to.

--- Patient dental chair;

--- Check chairs and sofas;

--- Patient support system of diagnosis and treatment equipment;

--- Operating table heating blanket;

--- Patient transfer equipment;

--- Conveyor table and bed;

--- Beds;

--- Field operating table.

1.3 Specific Standard

Addition.

The specific reference standard GB 9706.1-2007. "Medical Electrical Equipment Part 1. General requirements for safety." When the interest of brevity, in this specific standards referenced in Part 1, referred to as "General Standard" or "General requirements." The specific standard of articles, number and the number of chapters and the General Standard of the corresponding. Change the text of the provisions of the General Standard using the following vocabulary. "Replace" means the General Standard of the chapter or article is dedicated entirely replace standard text. "Supplement" means a standard text-based special supplement to the general requirements of the standard. "Edit" means the General Standard chapter or article as modified by this specific standard text.

Added to the General Standard bar or FIG numbered starting from 101, the supplemental appendix organized into AA, BB, etc. Added entry for aa), bb) and the like.

The term "this standard" is used as the common standards and of the specific standard collectively.

If this specific standard no corresponding article, chapter or article, the General Standard article, chapter or article (although probably not related) will be no change to apply; if GM intends to cite any part of the standard (although that may be relevant), will give a statement in this specific standard.

The specific requirements of the standard takes precedence over generic standards.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY 0570

EditionTitleRevisionStatus
YY 0570-2013Medical electrical equipment - Part 2: Particular requirements for the safety of operating tablescurrent editionCurrent
YY 0570-2005Medical electrical equipment - Part 2: Particular requirements for the safety of operating tablesprevious editionSuperseded

This page sells the current edition, YY 0570-2013. Earlier editions are listed for reference only.

How to Download YY 0570-2013

  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
18 pages
Instant delivery (0–9 sec)
Invoice included
View Cart

Secure payment via Stripe

Payments accepted

VisaMastercardAmerican ExpressApple PayGoogle PayStripe

YY 0570-2013

$225.00