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YY 0571-2013 English PDF (YY0571-2013)

YY 0571-2013 English PDF (YY0571-2013)

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YY 0571-2013: Medical electrical equipment. Part 2: Particular requirements for the safety of electrically operated hospital beds

YY 0571-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.99
C 46
Replacing YY 0571-2005
Medical electrical equipment - Part 2: Particular
requirements for the safety of electrically operated
hospital beds
(IEC 60601-2-38:1996, MOD)
ISSUED ON: OCTOBER 21, 2013
IMPLEMENTED ON: OCTOBER 01, 2014
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 5
SECTION ONE - GENERAL ... 7
1 Scope and object ... 7
2 Terminology and definitions ... 8
3 General requirements ... 11
5 Classification ... 11
6 Identification, marking and documents ... 12
SECTION TWO - ENVIRONMENTAL CONDITIONS ... 14
SECTION THREE - PROTECTION AGAINST ELECTRICAL SHOCK
HAZARDS ... 14
17 Separation ... 14
18 Protective earthing, functional earthing and potential equalization ... 15 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS ... 15
21 Mechanical strength ... 15
22 Moving parts ... 17
23 Surfaces, corners and edges ... 17
24 Stability in NORMAL USE ... 18
26 Vibration and noise ... 19
28 Suspended masses ... 19
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION ... 21
36 Electromagnetic compatibility ... 21
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES ... 21
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS ... 21
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility ... 22
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUT ... 23
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
ENVIRONMENTAL TESTS ... 23
52 Abnormal operation and fault conditions ... 23
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS ... 24
54 General ... 24
56 Components and general assembly ... 24
57 MAINS PARTS, components and layout ... 25
Appendix L (Normative) References - Publications mentioned in this Standard ... 38
Annex AA (Informative) Guidance and rationale for particular subclauses ... 39 Annex BB (Informative) Possible considerations and tests for ELECTRICALLY OPERATED HOSPITAL BEDS ... 46
Figure 101 -- ELECTRICALLY OPERATED HOSPITAL BED, general
arrangement ... 26
Figure 102 -- Distribution of the SAFE WORKING LOAD for tests ... 27
Figure 103 -- Lateral stability test: load arrangement (plan view) ... 28 Figure 104 -- Longitudinal stability test: load arrangement (plan view) ... 29 Figure 105 -- Lateral stability test: load arrangement (end elevation) ... 30 Figure 106 -- Longitudinal stability test: load arrangement (side elevation) ... 30 Figure 107 -- BED function controls and/or actuators: guidelines for creating graphic symbols ... 31
Figure 108 -- Graphic symbol for SAFE WORKING LOAD ... 32
Figure 109 -- Typical spacings for SQUEEZING and SHEARING POINTS ... 32 Figure 110 -- Clearance measurements around barriers ... 33
Figure 111 -- APPLIED PARTS region and potential equalization ... 33
Figure 112 -- Minimum angle between the back and leg/upper leg sections for various configurations of the MATTRESS SUPPORT PLATFORM [see item c)
of 56.10] ... 34
Figure 113 -- Application of forces for test of SIDE RAILS ... 35
Figure 114 -- Examples (only) of BEDS with segmented SIDE RAILS and single- piece SIDE RAILS ... 36
Figure 115 -- Test cone ... 37
Figure BB.1 -- Impactor ... 52
Figure BB.2 -- Loading positions ... 53
Figure BB.3 -- Loading pad ... 54
Figure BB.4 -- Recommended range of adjustment for sections of the
MATTRESS SUPPORT PLATFORM ... 55
Figure BB.5 -- Position of the LIFTING POLE handle ... 56
Foreword
The series of standards for the safety requirements of medical electrical equipment is mainly composed of two parts:
- Part 1: General requirements for the safety of medical electrical equipment; - Part 2: Particular requirements for the safety of medical electrical
equipment.
This Particular Standard belongs to Part 2: Particular requirements for the safety of medical electrical equipment. This Part is a modification and supplement to GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety".
This Standard replaces YY 0571-2005.
Compared with YY 0571-2005, the main differences of this Standard include: - Delete the content of national standard GB 9706.1-2007.
- Modify the editorial errors in the YY 0571-2005 standard.
This Particular Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard uses the redraft law to modify the international standard IEC 60601-2-38:1996 "Medical electrical equipment - Part 2: Particular
requirements for the safety of electrically operated hospital beds" and Amendment 1:1999.
The difference between this Standard and IEC 60601-2-38:1996 "Medical
electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds" and Amendment 1:1999 is mainly
manifested in:
- Clause 36 Electromagnetic compatibility. Because the IEC 60601-1-2
standard cited in IEC 60601-2-38:1996 and Amendment 1:1999 is the 1993
edition, and the corresponding industry standard YY 0505-2012 adopts the 2004 edition of IEC 60601-1-2; therefore, this Standard has made
necessary, reasonable and principle-equivalent modifications to the clause 36 of previous IEC 60601-2-38:1996 and Amendment 1:1999.
In addition, this Standard also makes the following editorial changes to IEC 60601-2-38:1996 and Amendment 1:1999:
- Replace the decimal point symbol "," with the decimal point symbol "."; - Delete the cover and foreword in the IEC 60601-2-38 standard;
- The translation of auxiliary verbs in this Standard is consistent with GB 9706.1-2007;
- In order to clarify the relevant standards cited in the standard, modify the informative appendix L.
- For other international standards quoted in the standard, if have been transformed into Chinese standards, this Part replaces the quoted
international standard number with the national standard number.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.
This Particular Standard was proposed by and shall be under the jurisdiction of Subcommittee 5 on Medical Electronic Instruments, National Technical
Committee 10 on Medical Electrical Equipment of Standardization
Administration of China (SAC/TC 10/SC 5).
Drafting organization of this Particular Standard: Shanghai Testing and Inspection Institute for Medical Devices.
Main drafters of this Standard: Liu Jiong, Xu Jin.
This Standard was first issued in 2005.
Medical electrical equipment - Part 2: Particular
requirements for the safety of electrically operated
hospital beds
SECTION ONE - GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies requirements for safety of ELECTRICALLY OPERATED HOSPITAL BEDS, hereinafter referred to as BED, as defined in
2.2.101.
1.2* Object
Replacement:
The object of this Particular Standard is to keep the SAFETY HAZARDS to PATIENTS, OPERATORS, and the environment as low as possible, and to
describe tests to verify that these requirements are attained.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of national standards, hereinafter referred to as “General Standard”, consisting of GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety" and GB 9706.15-2008 "Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems".
For brevity, GB 9706.1 is referred to in this Particular Standard either as the

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