YY 9706.257-2021 PDF in English
YY 9706.257-2021 (YY9706.257-2021) PDF English
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Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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YY 9706.257-2021: PDF in English YY 9706.257-2021
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 01.040.01
C 40
Medical electrical equipment - Part 2-57: Particular
requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use
(IEC 60601-2-57:2011, MOD)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: MAY 01, 2023
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 ... 8
201.4 General requirements ... 12
201.5 General requirements for testing ME EQUIPMENT ... 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 12
201.7 ME EQUIPMENT identification, marking and documents ... 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ... 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS ... 21
201.10 Protection against unwanted and excessive radiation HAZARDS ... 21
201.11 Protection against excessive temperatures and other HAZARDS ... 23
201.12 Accuracy of controls and instruments and protection against hazardous outputs
... 23
201.13 HAZARDOUS SITUATIONS and fault conditions ... 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 25
201.15 Construction of ME EQUIPMENT ... 25
201.16 ME SYSTEMS ... 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ... 25
Annexes ... 26
Annex AA (informative) Particular guidance and rationale ... 27
Annex BB (informative) Exposure limit Values ... 30
Annex CC (informative) Protective eyewear for LS EQUIPMENT ... 34
Annex DD (informative) Summary of MANUFACTURER’S requirements ... 35
Annex EE (informative) Symbols on marking ... 37
Bibliography ... 39
Foreword
This Part is mandatory for the full text.
“Medical electrical equipment” is divided into two parts:
- Part 1: General requirements for the basic safety and essential performance;
- Part 2: Particular requirements for the basic safety and essential performance.
This Part is “Medical electrical equipment - Part 2-57: Particular requirements for the
basic safety and essential performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use”.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part adopts the redrafting method to amend IEC 60601-2-57:2011 “Medical
electrical equipment - Part 2-57: Particular requirements for the basic safety and
essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use”.
There are technical differences between this Part and IEC 60601-2-57:2011, and the
clauses involved in these differences have been marked by a vertical single line (|) in
the position of the outer margin. The technical differences between this Part and IEC
60601-2-57:2011 and their reasons are as follows:
- Regarding normative references, this Part has made adjustments with technical
differences to adapt to the technical conditions of China. The adjustments are
concentrated in “201.2 Normative references”, and the specific adjustments are as
follows:
• REPLACE ISO 3864-2 with GB/T 2893.2, which is amended form the
international standard;
• REPLACE IEC 62471 with GB/T 20145, which is identical to the international
standards;
• REPLACE IEC 60947-3 with GB/T 14048.3, which is identical to the
international standard.
For ease of use, for IEC 60601-2-57:2011, this Part has made the following editorial
changes:
- DELETE the note in 201.3 about the index of terms and definitions;
- AMEND 202.102 in 201.6.1.102.2 b) TO 201.102, which is an editorial error.
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This Part was proposed by the National Medical Products Administration.
This Part shall be under the jurisdiction of Sub-Technical Committee on Medical Optics
and Instrument of Standardization Administration of China (SAC/TC 103/SC 1).
Drafting organization of this Part: Zhejiang Institute of Medical Device Testing.
Main drafters of this Part: Ye Yueshun, Li Min, Du Kun, Fang Chunzi.
Medical electrical equipment - Part 2-57: Particular
requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring and cosmetic/aesthetic use
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This Part applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of
equipment incorporating one or more sources of OPTICAL RADIATION in the
wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and
intended to create non-visual photo-biological effects in humans or animals for
therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications;
hereafter referred to as light source equipment (LS EQUIPMENT).
This Part does not apply to equipment for sun tanning, for ophthalmic instruments or
for infant phototherapy.
NOTE: Safety requirements in this Part are intended to address only HAZARDS to the eye and skin;
hazards to internal tissues are not included in its scope.
LS EQUIPMENT may consist of a single or multiple sources of OPTICAL
RADIATION, with or without power supply, or may be incorporated into a complex
system that includes optical, electrical or mechanical systems or sources of other
radiation.
NOTE: Annexes AA to EE have been included for purposes of general guidance and to illustrate
many typical cases. However, the annexes should not be regarded as definitive or exhaustive.
201.1.2 Object
Replacement:
The objects of this Part are:
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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