YY 0834-2011Medical electrical equipment - Part 2-35: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use (English PDF)

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.

The amendments and additions to the specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (hereinafter referred to as Common Criteria). The specific standard is equivalent to using the International Electrotechnical Commission IEC 60601-2-35 "Medical electrical equipment - Part 2-35. Medical Electric blankets, heating pads and electric mattresses requirements for safety "(in English). The specific standard compared with IEC 60601-2-35, the main difference as follows.

--- For other international standards quoted in the standard, if it has converted to our standards, the specific reference standard will replace the International Standard The corresponding number of national standards and Appendix L marked on the relationship;

--- IEC 60601-2-35, the term "Part 1" in this specific standard both use "common standards" instead of the corresponding specific standard By deleting the term "Part 1" of interpretation;

--- IEC 60601-2-35 Fig 101a and 101b of FIG pattern reversed, and this figure does not match the title of the specific standard has been modified;

--- IEC 60601-2-35 Appendix L, Annex ZA and Annex ZB incorporated in this specific standard for Appendix L.

The specific requirements of the standard should take precedence over generic standards.

The specific standard of articles, chapters and numbered in accordance with the General Standard article in the agreement.

Increase in the General Standard are numbered starting from 101 bar. Appendix increased upper-case letters AA, BB and so on. The small increase in branded items Letters aa), bb) and the like.

There is a corresponding principle, the terms or sub-clause, the clause made after the symbol "*." The specific standard Chapter 36 Electromagnetic compatibility and YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety and Standard column. EMC requirements and tests "earlier implementation.

The specific standard Appendix L, Appendix Appendix BB to EE normative annex, appendix AA informative appendices.

The specific criteria proposed by the State Food and Drug Administration.

The specific standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) Centralized.

The specific standard drafted by the State Food and Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center.

Introduction

The amended and supplemented specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" (idtIEC 60601-1. 1988 A1.1991 A2.1995) (see 1.3).

Due to the special nature of the heating device, that it is frequently used in the operating room, ICU and other patients may not make excessive temperatures Anti It should be the case, so this specific standard is required.

The specific standard pointed out additional safety requirements beyond common standards.

108 provides all the elements of the main requirements of this specific standard.

Should be K (Kelvin) temperature and the temperature difference between the absolute value of the unit, however, this specific standard of all used °C, because all measurements Amount is usually used in Celsius temperature scale devices.

For some with the clause or sub-clause numbers asterisk (*) in Annex AA after specific standard given in explanatory notes.

Medical electrical equipment - Part II. medical blankets, Electric mattress pads and requirements for the safety The first chapter outlines Except as follows, common standards this Title Chapter shall apply.

1 Scope and purpose

Except as follows, common standards in this chapter apply.

1.1 * Range increase.

This standard provides for special electric blankets, heating pads and electric mattress requirements, including electric mattresses and inflatable air cushion system. Defined 2.2.102,2.2.106 and 2.2.107.

Note: The specific standard, respectively, said electric blankets, heating pads or electric mattress, but with all of them to refer to the heating device. Heating device is a device for medical and paramedical care.

1.101 * Excluding equipment The specific standard does not apply to.

--- For heating equipment physical therapy;