YY 0600.1-2007 (YY0600.1-2007)
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Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices
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YY 0600.1-2007: PDF in English YY 0600.1-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Lung ventilators for medical use - Particular requirements
for basic safety and essential performance -
Part 1. Home-care ventilatory support devices
(ISO 10651-6.2004, MOD)
ISSUED ON. JANUARY 31, 2007
IMPLEMENTED ON. FEBRUARY 01, 2008
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 5
Introduction ... 7
1 Scope ... 9
2 Terms and definitions ... 10
3 General requirements ... 12
4 General requirements for tests ... 13
5 Classification ... 13
6 Identification, marking and documents ... 13
7 Power input ... 19
8 Basic safety categories ... 19
9 Removable protective means ... 19
10 Environmental conditions ... 19
11 Not used ... 20
12 Not used ... 20
13 General... 20
14 Requirements related to classification ... 20
15 Limitation of voltage and/or energy ... 21
16 Enclosures and protective covers ... 21
17 Separation ... 21
18 Protective earthing, functional earthing and potential equalization ... 21
19 Continuous leakage currents and patient auxiliary currents ... 21
20 Dielectric strength ... 21
21 Mechanical strength ... 22
22 Moving parts ... 22
23 Surfaces, corners and edges ... 22
24 Stability in normal use ... 22
25 Expelled parts ... 22
26 Vibration and noise ... 22
27 Pneumatic and hydraulic power ... 22
28 Suspended masses ... 22
29 X-ray radiation ... 22
30 α, β, γ, neutron radiation and other particle radiation ... 23
31 Microwave radiation ... 23
32 Light radiation (including lasers) ... 23
33 Infra-red radiation ... 23
34 Ultra-violet radiation ... 23
35 Acoustical energy (including ultrasonic) ... 23
36 Electromagnetic compatibility ... 23
37 Locations and basic requirements ... 24
38 Marking, accompanying documents ... 24
39 Common requirements for category AP and category APG equipment . 24
40 Requirements and tests for category AP equipment, parts and components
thereof ... 24
41 Requirements and tests for category APG equipment, parts and
components thereof ... 24
42 Excessive temperature ... 24
43 Fire prevention ... 24
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility ... 25
45 Pressure vessels and parts subject to pressure ... 27
46 Human errors ... 27
47 Electrostatic charges ... 27
48 Biocompatibility ... 27
49 Interruption of the power supply ... 27
50 Accuracy of the operating data ... 28
51 Protection against hazardous output ... 28
52 Abnormal operation and fault conditions ... 30
53 Environmental tests ... 31
54 General... 31
55 Enclosures and covers ... 31
56 Components and general assembly ... 31
57 Mains parts, components and layout ... 34
58 Protective earthing - Terminals and connections ... 34
59 Construction and layout ... 34
101 Alarm systems ... 34
102 Appendix of general standard ... 34
Appendix AA (Informative) Rationale ... 36
References ... 42
Figure 101 -- Configuration of test apparatus for measurement of
expiratory pressure and volume ... 30
Table 101 -- Conditions for expiratory pressure and volume
measurements ... 30
Foreword
YY 0600 “Lung ventilators for medical use - Particular requirements for basic
safety and essential performance” consists of the following components.
- Part 1. Home-care ventilatory support devices;
- Part 2. Home care ventilators for ventilator-dependent patients;
- Part 3. Emergency and transport ventilators.
The following parts of YY 0600 are under preparation.
- Part 4. Operator-powered resuscitators;
- Part 5. Gas-powered emergency resuscitators.
This part is part 1 of YY 0600, which modifies and adopts the international
standard ISO 10651-6.2004 “Lung ventilators for medical use - Particular
requirements for basic safety and essential performance - Part 6. Home-care
ventilatory support device” (English version). The main differences between this
part and ISO 10651-6.2004 are as follows.
- In this part, adjust the clause 2 “Normative references” of ISO 10651-6.2004
into 1.101; adjust the clause 3 “Terms and definitions” into clause 2, in order
to keep consistency with the number of general standard;
- In clause 46, it is modified into “do not adopt”;
- In 56.3 bb), modify the connector of the high-pressure input port to comply
with the provisions of Table 2 and Figure 3 of ISO 5359;
- DELETE the Appendix BB;
- The unit “hPa” in this part is converted to “kPa”.
This part is a particular standard based on GB 9706.1-2007 (IEC 60601-1.1988
+ Amd1.1991 + Amd2.1995, IDT) “Medical electrical equipment - Part 1.
General requirements for safety”, which is used in conjunction with GB 9706.1
AND implemented at the same time with GB 9706.1-2007 (IEC 60601-1.1988
+ Amd1.1991 + Amd2.1995, IDT).
The clause 36 of this part is implemented at the same time with YY 0505-2005
“Medical electrical equipment - Part 1-2. General requirements for safety -
Collateral standards. Electromagnetic compatibility - Requirements and tests”.
Introduction
This part of YY 0600 specifies the requirements for respiratory support devices
mainly for home-care use BUT which could be used elsewhere (in healthcare
facilities or other locations) for patients not dependent on ventilatory support,
i.e., where the ventilator is not considered to be life-supporting equipment.
These ventilators are frequently used in locations where driving power is not
reliable. These ventilators often are supervised by non-healthcare personnel
with varying levels of training.
This part of YY 0600 is a particular standard based on GB 9706.1 “Medical
electrical equipment - Part 1. General requirements for safety”, hereafter
referred to as the general standard. The general standard is the basic standard
for the safety of all medical electrical equipment used by OR under the
supervision of qualified personnel in the general medical and patient
environment; it also contains certain requirements for reliable operation to
ensure safety.
The general standard has associated collateral standards and particular
standards. The collateral standards include requirements for specific
technologies AND/OR hazards and apply to all applicable equipment, such as
medical systems, EMC, radiation protection in diagnostic X-ray equipment,
software, etc. The particular standard applies to specific equipment types, such
as medical electron accelerators, high frequency surgical equipment, hospital
beds, etc.
Note. Definitions of collateral standard and particular standard cab be found in
GB 9706.1-2007, clause 1.5 and the A.2, respectively.
This part of YY 0600 uses the same main clauses titles and numbering as the
general standard. The changes to the text of the general standard, as
supplemented by the collateral standards, are specified by the use of the
following words.
- “Replacement” means that the indicated clause or subclause of the general
standard is replaced completely by the text of this particular standard.
- “Addition” means that the relevant text of this particular standard is a new
element (e.g., subclause, list item, note, table, figure) additional to the
general standard.
- “Modification” means that an existing element of the general standard is
partially modified by deletion AND/OR addition as indicated by the text of
this particular standard.
Lung ventilators for medical use - Particular requirements
for basic safety and essential performance -
Part 1. Home-care ventilatory support devices
1 Scope
GB 9706.1-2007, clause 1 applies, except as follows.
Modification.
This part of YY 0600 specifies the basic safety and essential performance
requirements for home-care vent...
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