YY 9706.252-2021 PDF English
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YY 9706.252-2021: Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
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YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.99
C 46
Replacing YY 0571-2013
Medical Electrical Equipment - Part 2-52.Particular
Requirements for the Basic Safety and Essential
Performance of Medical Beds
(IEC 60601-2-52.2009+AMD1.2015, MOD)
Issued on. SEPTEMBER 06, 2021
Implemented on. MAY 01, 2024
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
201.1 Scope, Object and Related Standards... 5
201.2 Normative References... 7
201.3 Terms and Definitions... 7
201.4 General Requirements... 12
201.5 General Requirements for Testing of ME EQUIPMENT... 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS... 14
201.7 ME EQUIPMENT Identification, Marking and Documents... 15
201.8 Protection against Electrical HAZARDS from ME EQUIPMENT... 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS... 21
201.10 Protection against Unwanted and Excessive Radiation HAZARDS... 46
201.11 Protection against Excessive Temperatures and Other HAZARDS... 46
201.12 Accuracy of Controls and Instruments and Protection against
Hazardous Outputs... 49
201.13 HAZARDOUS SITUATIONS and Fault Conditions... 49
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 50
201.15 Construction of ME EQUIPMENT... 51
201.16 ME SYSTEMS... 54
201.17 Electromagnetic Compatibility of ME EQUIPMENT and ME SYSTEMS
... 54
Annexes... 55
Annex AA (Informative) Particular Guidance and Rationale... 56
Annex BB (Informative) Particular Guidance for Assessing Risk of Entrapment
in V-Shaped Openings... 74
Annex CC (Normative) Design Requirements and Recommendations for
MEDICAL BEDS... 80
Bibliography... 89
Index of Defined Terms Used in this Part... 90
Foreword
All the technical contents in this Standard are mandatory.
YY 9706 Medical Electrical Equipment serial standards can be divided into the
following two parts.
--- Part 1.General and Collateral Requirements;
--- Part 2.Particular Requirements.
This Part is Part 2-52 of YY 9706.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part replaced YY 0571-2013 Medical Electrical Equipment - Part 2.Particular
Requirements for The Safety of Electrically Operated Hospital Beds. Compared with
YY 0571-2013, the major technical changes of this Part are as follows besides the
editorial modifications.
--- Corresponding to the general standard, the structure of this Part is adjusted from
the original 10 chapters and 57 clauses into 17 clauses;
--- Modify the scope and purpose content (see 201.1 of this Edition; Clause 1 of the
2013 Edition);
--- According to the original text of the IEC, this Part has made amendments to the
obvious errors in YY 0571-2013 when describing the relevant content (see
201.9.2.3.1, sub-clause 201.13.14 of this Edition; 22.2.102, 52.5.101 of 2013
Edition);
--- Corresponding to the general standards, add the requirements for risk
management (see 201.4.2.2 of this Edition);
--- Add test evaluation content and specify specific implementation methods of test
evaluation (see Tables 201.101 and 201.102 of this Edition);
--- Add the requirement of identification mark (see 201.7.2.2.107 of this Edition);
--- In order to facilitate the understanding of the standard numbers and names in
Annexes AA, BB, and CC, retain the standard number and name of the original
IEC;
--- Add Bibliography (see bibliography of this Edition);
--- Add an index of terms and definitions (see 201.3 of this Edition).
This Part used the redrafting method to modify and adopt IEC 60601-2-52.2009
Medical Electrical Equipment – Part 2-52.Particular Requirements for the Basic Safety
and Essential Performance of Medical Beds.
The technical differences and causes between this Part and IEC 60601-2-52.2009 are
as follows.
--- Regarding normative references, this Part has made adjustment with technical
differences to adapt to the technical conditions of China. The adjustments are
concentrated in Clause 2 "Normative References"; and the specific adjustments
are. Use GB/T 2423.7-2018 that equivalently adopt international standard to
replace IEC 60068-2-31.2008.
This Part made the following editorial modifications.
--- Incorporate the content of the International Standard Amendment IEC 60601-2-
52.2009/AMD1.2015.
Please note some contents of this Document may involve patents. The issuing agency
of this Document shall not assume the responsibilities to identify these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of Subcommittee for Standardization of Medical
Electronic Instrument of National Technical Committee for Standardization of Medical
Electrical Appliance (SAC/TC 10/SC 5).
Drafting organizations of this Part. Paramount Bed Co., Ltd.; and Shanghai Testing &
Inspection Institute for Medical Devices.
Chief drafting staffs of this Part. Huang Zhenfeng, Xu Chao, Zhuang Jun, Chen
Pengzhong, and Cao Yan.
The historical editions replaced by this Part are as follows.
--- YY 0571-2005;
--- YY 0571-2013.
Medical Electrical Equipment - Part 2-52.Particular
Requirements for the Basic Safety and Essential
Performance of Medical Beds
201.1 Scope, Object and Related Standards
Clause 1 of the general standard1) applies, except as follows.
201.1.2 Object
The object of this Part is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.212 intended
for ADULTS as defined in 201.3.219.
201.1.3 Collateral standards
This Part refers to those applicable collateral standards that are listed in Clause 2 of
the general standard and Clause 2 of this Part.
201.1.4 Particular standards
In the 9706 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the
particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY
and ESSENTIAL PERFORMANCE requirements.
201.2 Normative References
Informative references are listed in the bibliography on page 61.
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document. Clause 2 of the general standard applies
except as follows.
201.3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB 9706.1 apply,
except as follows.
201.4 General Requirements
Clause 4 of the general standard applies, except as follows.
201.5 General Requirements for Testing of ME
Clause 5 of the general standard applies, except as follows.
201.6 Classification of ME EQUIPMENT and ME
Clause 6 of the general standard applies, except as follows.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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