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Medical electrical equipment. Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
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Standard similar to YY 0627-2008 GB/T 37637 GB 7000.1 SN/T 1588.3 Basic data | Standard ID | YY 0627-2008 (YY0627-2008) | | Description (Translated English) | Medical electrical equipment. Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | K73 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 33,323 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-12-01 | | Older Standard (superseded by this standard) | YY 0568-2005 | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the 2. 101 ~ 2. 105 defined and diagnostic surgical shadowless illumination lamp (hereinafter referred to as: Equipment) requirements. This standard does not apply to: Headlight, endoscopes and endoscopic light source, such equipment in GB 9706. 19-2000 already specified in the standard, dental lights, by the ISO 9680 requirements, general purpose lighting by GB 7000. 10-1999 and GB 7000. 11-1999 regulations, emergency lighting by GB 7000. 2-1999 requirements. | YY 0627-2008: Medical electrical equipment. Part 2-41: Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
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Medical electrical equipment.Part 2-41. Particular requirements for the safety of surgical luminaries and luminaries for diagnosis
ICS 11.040.01
C40
People's Republic of China pharmaceutical industry standards
Replacing YY 0102 ~ 0103-1993
YY 0568-2005
Medical electrical equipment -
Part 2. Operation Lamp and diagnostic lights
Requirements for safety
(IEC 60601-2-41.2000, MOD)
Posted 2009-12-01 2008-04-25 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
The first chapter Overview 1
1. Scope and purpose 1
2 Terms and definitions 2
4 4 General test requirements
5 Category 4
6 Identification, marking and documents 4
The second environmental conditions 5
Third of the risk of electric shock protection 5
Requirements concerning classification of 14 5
16 housing and protective cover 5
Title IV of the mechanical hazards Protection 5
22 sports section 5
24 Stability in normal use 6
25 spatter 6
The fifth chapter of unwanted or excessive radiation hazard protection 6
34 UV radiation 6
Title VI of the danger of ignition of flammable anesthetic mixture Protection 6
Title VII of the ultra-mild other security risk protection 7
42 overtemperature 7
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection and sterilization 7
49 interrupt the power supply 7
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 11
52 abnormal operation and fault status 11
Tenth Canto structural requirements 11
Housing 55 and cover 11
56 11 components and subassemblies
Net power supply section 57, components and wiring 11
59 structure and wiring 12
COMPILATION THEORY Annex AA (informative) Introduction of the specific standard Chapter 23
Appendix NA (informative) This standard and IEC 60601-2-41.2000 technical differences and their reasons 25
Appendix NB (normative) Normative documents 27
101 Operation Lamp power supply, for example 12
102 No Stipe installation and removal tests 13
103 mobile portable test 14
FIG. 104 15 distribution spots
105 Center illuminance measurement 16
106 spot diameter and the diameter distribution measuring spot 16
107 single shutter illuminance measurement 17
Figure 108 pairs of shutters illuminance measurement 17
109 groups of measurement double shutter double shutter rate of four different positions 18
Figure 110 lumen deep bottom illuminance measurement 19
111 lumen deep partial cross-sectional view 19
112 single shutter deep cavity at the bottom of illuminance measurements 20
Figure 113 pairs of shutter deep cavity at the bottom of illuminance measurements 20
Four different measuring positions 114 double shutter deep cavity shadowless rate double shutter 21
115 depth measurement beam 22
Figure AA. 1 a conversion period of the emergency power supply system 24
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.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Shanghai Medical Device Inspection
The measured.
The main drafters of this standard. JIA Xiao Hang, Wang Jingtao, He Tao, Qian Xiaoyang Li.
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.
1.2 Purpose
replace.
The specific standard is intended to determine the safety and diagnostic surgery shadowless lighting of special requirements.
1.3 Specific Standard
supplement.
The specific reference to the standard GB 9706.1-1995 "Medical Electrical Equipment Part 1. General requirements for safety."
GB 9706.1-1995 standard referred to as "General Standard" or "General requirements" in this specific standard.
The specific standard parts, chapters, bars and common standards corresponding parts, chapters, strip the same. The specific standard provisions of the General Standard change
Change, specify the text represented by the following.
"Replace" means the General Standard or chapter shall be completely replaced in this specific standard provisions;
"Supplement" means this special supplement to the standard provisions of the General Standard;
"Improvement" means the General Standard or chapter shall be to improve the standard of this special provision;
"Edit" means the General Standard or chapter shall be amended in this specific standard provisions.
General Standard supplement or chart sub-clause, numbered starting from 101, supplementary appendices letters AA, BB, said supplement
Entries with aa), bb), Fig.
"This standard" means the General Standard and this Particular Standard collectively.
Part of the specific standard is not involved in the clause or subclause of the General Standard of the portion, if applicable, without modification.
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