YY 0896-2013_English: PDF (YY0896-2013)
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Medical electrical equipment. Part 2: Particular requiremetns for the safety of electromyograohs and evoked response equipment
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YY 0896-2013
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| Standard ID | YY 0896-2013 (YY0896-2013) | | Description (Translated English) | Medical electrical equipment. Part 2: Particular requiremetns for the safety of electromyograohs and evoked response equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 12,179 | | Adopted Standard | IEC 60601-2-40-1998; MOD | | Drafting Organization | Shanghai Medical Device Testing | | Administrative Organization | National Standardization Committee Medical Electrical Medical Electronic Instrument Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | National Committee for Standardization of Medical Electrical Equipment Standardization Subcommittee (SAC/TC 10/SC 5) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: 2. 1. 101 defined EMG equipment and 2. 1. 102 defined evoked response equipment, collectively equipment below. |
YY 0896-2013
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 39
Medical electrical equipment - Part 2. Particular
requirements for the safety of electromyographs and
evoked response equipment
(IEC 60601-2-40.1998, Medical electrical equipment - Part 2-40. Particular
requirements for the safety of electromyographs and evoked response
equipment, MOD)
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 4
Section 1. General ... 6
1 Scope and object ... 6
2 Terminology and definitions ... 8
5 Classification... 9
6 Identification, marking and documents ... 9
7 Power input ... 11
Section 2. Environmental conditions ... 12
Section 3. Protection against electric shock hazards ... 12
14 Requirements related to classification ... 12
20 Dielectric strength ... 12
Section 4. Protection against mechanical hazards ... 13
Section 5. Protection against hazards from unwanted or excessive radiation ... 13
36 Electromagnetic compatibility ... 13
Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures . 14
Section 7. Protection against excessive temperatures and other safety hazards ... 14
42 Excessive temperatures ... 14
46* Human errors ... 14
Section 8. Accuracy of operating data and protection against hazardous output ... 15
50 Accuracy of operating data ... 15
51 Protection against hazardous output ... 16
Section 9. Abnormal operation and fault conditions; environmental tests ... 16
Section 10. Constructional requirements ... 17
Annex L (normative) Normative references ... 18
Annex AA (informative) General guidance and rationale ... 19
Foreword
Medical electrical equipment standards are a series of standards, consisting of two
major parts.
- Part 1. General requirements for safety of medical electrical equipment;
- Part 2. Particular requirements for safety of medical electrical equipment.
This Particular Standard is Part 2-40 of Medical electrical equipment.
This Particular Standard is the amendment and addition of GB 9706.1-2007 “Medical
electrical equipment - Part 1. General requirements for safety”.
This Particular Standard is drafted according to the rules given in GB/T 1.1-2009.
This Particular Standard uses redrafting method to amend and adopt the International
Electrotechnical Commission Standard IEC 60601-2-40.1998 “Medical electrical
equipment - Part 2-40. Particular requirements for the safety of electromyographs and
evoked response equipment” (English version).
Main technical differences between this Standard and IEC 60601-2-40.1998 are as
follows.
- Clause 36 in IEC 60601-2-40.1998 is the addition to the collateral standard IEC
60601-1-2.1993, and China's current electromagnetic compatibility standards YY
0505-2012 “Medical electrical equipment - Part 1. General requirements for safety
- 2. Collateral standard. Electromagnetic compatibility - Requirements and tests”
is equivalent to IEC 60601-1-2.2004. Therefore, in the development of this
Particular Standard, the Standardization Administration of China believes that it is
necessary to update the specifications on electromagnetic compatibility with
reference to the requirements of the latest collateral standards.
- For the other International standards referenced in the standard, if the standard
has been transformed into China’s national standard, the referenced China’s
national standards shall prevail;
- DELETE the cover and foreword of IEC 60601-2-40.1998.
This Particular Standard is the amendment and addition of GB 9706.1-2007 “Medical
electrical equipment - Part 1. General requirements for safety”, so this Particular
Standard takes priority over the General Standard.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. Issuing organizations of this document shall not be held
responsible for identifying any or all such patent rights.
This Particular Standard is proposed and under the jurisdiction of Technical Sub-
Committee on Medical Electrical Equipment of National Technical Committee on
Medical Electrical Equipment of Standardization Administration of China (SAC/TC
10/SC 5).
Drafting organization of this Particular Standard. Shanghai Medical Devices Testing
Institute.
Main drafters of this Particular Standard. Shi Daifeng, Tao Kan.
Medical electrical equipment - Part 2. Particular
requirements for the safety of electromyographs and
evoked response equipment
Section 1. 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 applies to ELECTROMYOGRAPHS as defined in 2.1.101 and
EVOKED RESPONSE EQUIPMENT as defined in 2.1.102, hereinafter referred to as
EQUIPMENT.
1.2 Object
Replacement.
The object of this Particular Standard is to establish particular requirements for the
safety of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT as
defined in 2.1.101 and 2.1.102, respectively.
1.3 Particular Standards
Addition.
This Particular Standard refers to GB 9706.1-2007.
Part 1 is referred to in this Particular Standard either as the “General Standard” or as
the “General Requirement(s)”.
36.202.2.2 The use of the phantom is intended to standardize the testing for EMC,
particularly for susceptibility.
Contamination of the display resulting from the radiated radiofrequency
electromagnetic field tests is not considered to be hazardous and, therefore, not a non-
compliance.
Instructions for use should specify maximum electromagnetic fields within which all
performance specifications will be met, if these are necessarily lower than the levels
specified for the tests of 36.202.2.1.
46 Switching on the ELECTRICAL STIMULATOR inadvertently is considered to be a
normal occurrence since the ELECTRICAL STIMULATOR is likely to be short-circuited
or open-circuited accidentally during use due to movements of the electrodes and/or
the PATIENT.
50.1 A small increase in output amplitude may produce a disproportionate stimulus to
the PATIENT. A control which enables the USER to adjust the output amplitude
smoothly or in small increments is considered to be an important safety feature.
Limitation of the output available at the minimum setting of the output control enables
the USER to commence stimulation from a low output level.
50.2 An accuracy of ± 30 % is considered to provide adequate safety, since the values
selected are mainly determined by the electrophysiological responses and the
subjective reaction of the PATIENT.
51.101 Supply voltage fluctuations not exceeding the limit of the General Standard
should not influence the output parameters excessively.
51.102 The indication should advise the USER that the ELECTRICAL STIMULATOR
is delivering stimuli, or that the ELECTRICAL STIMULATOR is armed to deliver stimuli
as a result of further action by the USER, for example manual triggering.
51.103 Experience shows that the limits specified allow all known diagnostic
applications to be carried out without exceeding the allowable value.
51.105 The value of 125 dB HTL is taken from GB/T 7341.3-1998.
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