YY 0627-2008Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis (English PDF)

Foreword

The revised standards adopted IEC 60601-2-41:2000 "Medical electrical equipment - Part 2. Operation Lamp and diagnostic lights Security Full-specific requirements "(in English).

This standard and IEC 60601-2-41:2000 The main differences are as follows.

a) The standard form of notes recommended radiometer accuracy requirements and respond to the requirements of cut-off wavelength;

b) The standard proposed other methods of measurement of irradiance in note form.

This standard is based on IEC 60601-2-41:2000 redrafting changes, modifications and technical differences made have been incorporated into the text and in their Logo | involved in terms of the margin of a single vertical line (). Appendix NA (informative) given in these technical differences and List the reasons for your reference.

For ease of use, the IEC 60601-2-41:2000 This standard also made the following editorial changes.

a) Remove IEC 60601-2-41:2000 Foreword and Introduction;

b) IEC 60601-2-41:2000 Measurement 50.102.3.1 references 50.102.1.2.1 error, change in this standard with the terms As 50.102.1.2;

c) Added Appendix NA (informative);

d) Added Appendix NB (normative).

This standard is the same time GB 9706.1-1995 (idt IEC 601-1. 1988) "Medical Electrical Equipment Part 1. General requirements Safety Seeking "Supplements and Amendments to the structure and terms of numbers and GB 9706.1-1995 (idt IEC 601-1. 1988) correspond.

This standard appendix AA, NA appendix is an informative annex, appendix NB this standard is a normative appendix.

From the date of implementation of this standard, YY 0102-1993 "hole operation shadowless lamp", YY 0103-1993 "cold light single hole surgery"

YY 0568-2005 "Medical electrical equipment - Part 2. diagnostic and surgical lighting lighting safety requirements" shall be repealed simultaneously.

Introduction

This standard is about the diagnosis and surgical shadowless lighting of the safety standards, is GB 9706.1-1995 "Medical Electrical Equipment Part I. General Requirements for Safety "(hereinafter referred to as the General Standard) of additions and amendments. The specific requirements of the standard in preference to the General Standard Requirements. This standard formatted with IEC 60601-2-41:2000 agreement.

The standard italic font, indicating that the present standard GB 9706.1-1995 (IEC 601-1. 1988) Chapter or under any terms change.

In this standard chapter or article number next to the asterisk (*) mark indicates Annex AA (informative) gives the explanation.

The standard "preparation principle Introduction" Writing in Annex AA (informative appendix).

Understand the principles of this standard Annex AA (informative) Introduction of preparation, not only contribute to the correct application of this standard, and with the We need to change clinical practice or technological developments will facilitate the revision of this standard. However, the appendix does not form part of the requirements of this standard.

Medical electrical equipment - Part 2. Operation Lamp and diagnostic lights Requirements for safety The first chapter outlines Except for the following provisions, common standards this Title Chapter shall apply.

1 Scope and purpose

Except for the following provisions, common standards in this chapter apply. 1.1* Scope supplement.

The specific standard details the 2.101 ~ 2.105 as defined in the diagnosis and surgical shadowless lamp (hereinafter. equipment) Claim. This standard does not apply to.

---headlamp;

--- Endoscopes and endoscopic light sources, such equipment in GB 9706.19-2000 standard already specified;

--- Dental lights, prescribed by the ISO 9680;

--- General-purpose lighting, and by the GB 7000.10-1999 GB 7000.11-1999 provisions;

--- Emergency lighting, by the provisions of GB 7000.2-1999.

NOTE: In the lighting field hospital clinical use, except as defined in this standard 2.105 ~ 2.101, and the rest by the GB 7000.16-2000 specified.