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YY 9706.252-2021 English PDF (YY9706.252-2021)

YY 9706.252-2021 English PDF (YY9706.252-2021)

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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

YY 9706.252-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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).
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:
201.1.1 * Scope
Replacement:
This Part specifies the basic safety and essential performance of medical beds that include a mattress support table intended for sleep/rest, and equipment intended to help diagnose, monitor, prevent, treat, alleviate disease, or compensate for injury or disability. It is suitable for adult patients with a height equal to or greater than 146cm, a mass equal to or greater than 40kg, and a body mass index (BMI) equal to or greater than 17.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this Part are not covered by specific requirements in this Part except in 7.2.13 and 8.4.1 of the general standard.
NOTE: See also 4.2 of the General Standard.
201.1.2 Object
Replacement:
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.
1) The general standard is GB 9706.1-2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

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