YY 0896-2013: Medical electrical equipment. Part 2: Particular requiremetns for the safety of electromyograohs and evoked response equipment

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY 0896-2013 (Self-service in 1-minute)
Newer / historical versions: YY 0896-2013

Preview True-PDF

Scope

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.

Basic Data

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 and Pharmaceutical Industry Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.50
Word Count Estimation	12,171
Adopted Standard	IEC 60601-2-40-1998; MOD
Regulation (derived from)	State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
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.