GB 9706.27-2005 English PDF (GB9706.27-2005)

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GB 9706.27-2005: Medical electrical equipment -- Part 2-24: Particular requirements for the safety of infusion pumps and controllers
GB 9706.27-2005
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
GB 9706.27-2005 / IEC 60601-2-24.1998
Medical electrical equipment - Part 2-24. Particular
requirements for the safety of infusion pumps and
controllers
(IEC 60601-2-24.1998, IDT)
ISSUED ON. NOVEMBER 24, 2005
IMPLEMENTED ON. AUGUST 1, 2006
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 5 
Introduction ... 7 
SECTION ONE - GENERAL ... 8 
1 Scope and object ... 8 
2 Terminology and definitions ... 10 
3 General requirements ... 15 
4 Test general requirements ... 16 
5 Classification ... 17 
6 Identification, marking and documents ... 18 
SECTION TWO - ENVIRONMENTAL CONDITIONS ... 25 
8 Basic safety type ... 25 
10 Environmental conditions ... 25 
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
... 25 
14 Requirements related to classification ... 25 
17 SEPARATION ... 26 
18 Protective grounding, functional grounding and potential equalization ... 28 
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS ... 29 
20 Dielectric strength ... 32 
SECTION FOUR- PROTECTION AGAINST MECHANICAL HAZARDS ... 32 
21 Mechanical strength ... 33 
SECTION FIVE- PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION ... 34 
36* Electromagnetic compatibility ... 34 
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES ... 35 
40 Requirements and tests for type AP equipment and its parts and
components ... 35 
41 Requirements and tests for type APG equipment and its parts and
components ... 36 
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS ... 36 
43 Fire prevention ... 36 
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility ... 37 
47 Electrostatic charges ... 39 
48 Material of applied part in contact with patient’s body ... 39 
48 Biocompatibility ... 40 
49 Interruption of the power supply ... 40 
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT ... 40 
50 Accuracy of operating data ... 41 
51 Protection against hazardous output ... 62 
SECTION NINE - Abnormal operation and fault conditions; environmental test
... 68 
52 Abnormal operation and fault conditions ... 68 
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS ... 69 
Annex L (Informative) References ... 78 
Annex AA (Informative) General guidance and rationale ... 79 
Annex BB (Normative) Normative references ... 108 
Foreword
There are series of standards of medical electrical equipment, which mainly
consist of two parts.
- Part 1. general safety requirements for medical electrical equipment;
- Part 2. particular requirements for medical electrical equipment.
This Particular Standard is particular requirements for the safety of infusion
pumps and controllers of Part 2. This Standard identically uses IEC 60601-2-
24.1998 Medical electrical equipment - Part 2-24. Particular requirements for
the safety of infusion pumps and controllers (English version).
Compared with IEC 60601-2-24.1998, the editorial differences in this Particular
Standard are as follows.
- for other International standards used as references in IEC 60601-2-
24.1998, if they have been used in China standards, it shall replace the
reference numbers of the International standards by China’s;
- for easy use, added the normative Annex BB “Normative references”;
modified the informative Annex L “Bibliography” and incorporated part of
the standard directory into Annex BB;
- the content of Clause 36 of IEC 60601-2-24.1998 used the standard of
IEC 60601-1-2.1993 but this edition (Edition 1993) has been replaced by
Edition 2001, therefore Clause 36 of this Particular Standard uses
requirements of YY 0505-2005;
- incorporated the relevant requirements of Amendment 2 (1995) of IEC
60601-1.1988 into corresponding terms of this Standard so as to make
this Particular Standard consistent with IEC 60601-2-24.1998. to make it
distinguished with particular standard, the content of Amendment 2 has
been marked by double vertical line in this Particular Standard.
This Particular Standard uses GB 9706.1-1995 Medical electrical equipment--
Part 1. General requirements for safety (idt IEC 60601-1.1988 + Amendment 1
(1991)) and IEC 60601-1.1998 Amendment 2 (1995) Medical electrical
equipment--Part 1. General requirements for safety Amendment 2, YY 0505-
2005 Medical electrical equipment Part 1-2. General requirements for safety -
Collateral standards. Electromagnetic compatibility - Requirements and tests
(IEC 60601-1-2.2001, IDT) as references.
Annex L, Annex AA of this Particular Standard are informative; Annex BB is
normative.
This Particular Standard was proposed by Sub-committee on Medical
Electronic Equipment of National Technical Committee on Medical Electrical
Equipment of Standardization Administration of China.
This Particular Standard shall be under the jurisdiction of Sub-committee on
Medical Electronic Equipment of National Technical Committee on Medical
Electrical Equipment of Standardization Administration of China.
The drafting organization of this Particular Standard. Shanghai Institute of
Medical Instrumentation.
Main drafters of this Particular Standard. Xu Yuemin, Liu Qun.
Medical electrical equipment - Part 2-24. Particular
requirements for the safety of infusion pumps and
controllers
SECTION ONE - GENERAL
The clauses and sub-clauses of this section of the General Standard and of this
section of the Collateral Standard YY 0505-2005 apply, except as follows.
1 Scope and object
The clause of the General Standard and this clause of the Collateral Standard
YY 0505-2005 apply, except as follows.
1.1* Scope
Addition.
This Particular Standard specifies the requirement for infusion pumps, infusion
controllers, syringe pumps and pumps for ambulatory use, as defined in 2.101
to 2.110. These devices are intended for use by medical staff and home patients
as prescribed and medically indicated. These particular requirements do not
apply to devices.
- specifically intended for diagnostic or similar use (e.g. angiography or
other pumps permanently controlled or supervised by the operator);
- enteral infusion;
- extracorporeal circulation of blood;
- implantable or disposable devices;
- equipment specially intended for diagnostic use within urodynamics
(measurement of pressure-volume relationship of the urinary bladder
when filled through a catheter with water);
- equipment specially intended for diagnostic use within male impotence
testing (measurement of amount of liquid infused, necessary to maintain
a preset pressure level for maintaining penile erection. cavernosometry,
cavernosography).
Annex BB
(Normative)
Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For dated references, the subsequent
amendments (exc...