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

医用电气设备第2部分：医院电动床安全专用要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 21, 2013

Implementation date

October 1, 2014

Scope

YY 0571-2013 is the English-translated version of 医用电气设备第2部分：医院电动床安全专用要求.

YY 0571-2013 is the Chinese standard "Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds". Its scope clause reads: This clause of the General Standard applies, except as follows.

A requirement of this Particular Standard replacing or modifying requirements of the General Standard or the Collateral Standard takes precedence over the corresponding General Requirement(s).

Its clauses include scope and object; terminology and definitions; general requirements; classification; identification, marking and documents.

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Document preview — YY 0571-2013

National Standard of the People's Republic of China

Replacing: YY 0571-2005

Issued by: National Medical Products Administration of the People's Republic of China

Foreword5
SECTION ONE - GENERAL7
1 Scope and object7
2 Terminology and definitions8
3 General requirements11
5 Classification11
6 Identification, marking and documents12
SECTION TWO - ENVIRONMENTAL CONDITIONS14
HAZARDS14
17 Separation14
18 Protective earthing, functional earthing and potential equalization15
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS15
21 Mechanical strength15
22 Moving parts17
23 Surfaces, corners and edges17
24 Stability in NORMAL USE18
26 Vibration and noise19
28 Suspended masses19
EXCESSIVE RADIATION21
36 Electromagnetic compatibility21
FLAMMABLE ANAESTHETIC MIXTURES21
AND OTHER SAFETY HAZARDS21
sterilization, disinfection and compatibility22
AGAINST HAZARDOUS OUT23
ENVIRONMENTAL TESTS23
52 Abnormal operation and fault conditions23
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS24
54 General24
56 Components and general assembly24
57 MAINS PARTS, components and layout25
Annex AA (Informative) Guidance and rationale for particular subclauses39
OPERATED HOSPITAL BEDS46
arrangement26
graphic symbols31
of 56.10]34
piece SIDE RAILS36
Figure BB.1 -- Impactor52
Figure BB.2 -- Loading positions53
Figure BB.3 -- Loading pad54
MATTRESS SUPPORT PLATFORM55
Figure BB.5 -- Position of the LIFTING POLE handle56

1 Scope and object

This clause of the General Standard applies, except as follows.

A requirement of this Particular Standard replacing or modifying requirements of the General Standard or the Collateral Standard takes precedence over the corresponding General Requirement(s).

2 Terminology and definitions

This clause of the General Standard applies except as follows.

BED and its accessories intended for use in the diagnosis, treatment or monitoring of an adult PATIENT whilst under medical supervision (hereinafter referred to as BED).

3 General requirements

This clause of the General Standard applies except as follows.

If alternative means of construction have been employed or if a requirement of this Standard has not been met, in order to provide benefit to the PATIENT, a risk assessment shall be performed (in accordance with YY/T 0316-2008) to demonstrate that the overall level of safety has not been compromised.

5 Classification

This clause of the General Standard applies except as follows.

6 Identification, marking and documents

This clause of the General Standard applies except as follows.

YY/T 0506.8-2019 | YY/T 0506.7-2014 | YY 0600.2-2007 | YY 0600.1-2007 | YY/T 0337-2025 | […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 56 pages — is available in the English PDF.

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YY 9706.252-2021|GB/T 42125.19-2022|GB/T 14536.13-2022|GB/T 4214.11-2021|YY 9706.287-2025|YY 9706.230-2023

Editions of YY 0571

Edition	Title	Revision	Status
YY 0571-2013	Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds	current edition	Current
YY 0571-2005	Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds	previous edition	Superseded

This page sells the current edition, YY 0571-2013. Earlier editions are listed for reference only.

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