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GB 9706.28-2006

GB 9706.28-2006_English: PDF (GB9706.28-2006)
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GB 9706.28-2006English1269 Add to Cart Days<=8 Medical electrical equipment -- Part 2: Particular requirements for the safety of lung ventilators -- Critical care ventilators GB 9706.28-2006 Valid GB 9706.28-2006
 

BASIC DATA
Standard ID GB 9706.28-2006 (GB9706.28-2006)
Description (Translated English) Medical electrical equipment. Part 2: Particular requirements for the safety of lung ventilators. Critical care ventilators
Sector / Industry National Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 53,596
Date of Issue 2006-07-25
Date of Implementation 2007-05-01
Adopted Standard IEC 60601-2-12-2001, MOD
Drafting Organization Shanghai Medical Instruments Co., Ltd. Medical Equipment Factory
Administrative Organization Anaesthetic and respiratory equipment National Standardization Technical Committee; National Standardization Technical Committee of Medical Electrical Medical Electronic Instrument Standardization Technical Committee
Regulation (derived from) Announcement of Newly Approved National Standards No. 9, 2006 (No. 96 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This Chinese standard applies to the treatment of ventilator (defined by 2. 1. 125) security. This standard does not apply to special continuous positive airway pressure (CPAP) devices, sleep apnea therapy equipment, strengthen ventilator, anesthesia ventilator, emergency ventilator, high-frequency and high-frequency jet ventilator oscillating ventilator does not include hospital used only as increasing patient ventilation equipment.

GB 9706.28-2006
Medical electrical equipment.Part 2. Particular requirements for the safety of lung ventilators.Critical care ventilators
ICS 11.040.10
C 46
National Standards of People's Republic of China
Medical electrical equipment
Part 2. Specific requirements for ventilator safety
Therapeutic ventilator
2006-07-25 posted
2007-05-01 Implementation
First overview
Except for the following, the chapters and clauses of this chapter of the General Standard apply.
1 * Scope and purpose
Except for the following, this chapter of the general standard applies.
1.1 Application
increase.
This specific standard applies to the safety of therapeutic ventilators (as defined in 2.1.125).
This specific standard does not apply to CPAP equipment, sleep apnea therapy equipment, boosters, anesthesia breathing
Machine, emergency ventilator, high-frequency jet ventilator and high-frequency oscillatory ventilator
device.
1.2 * Purpose
increase.
The purpose of this special standard is to specify special safety requirements for therapeutic ventilator.
1.3 * Specific standards
increase.
This special standard refers to GB 9706.1.1995 "Medical Electrical Equipment Part 1. General Safety Requirements" and supplements IEC
60601-1. 1988 "Medical Electrical Equipment Part 1. General Requirements for Safety" Amendment 2 (1995).
When GB 9706.1-1995 is referred to in this special standard, it is referred to as "general standard" for short. For the standard GB 9706.15-1999
(IEC 60601-1-1..1995X (Medical electrical equipment Part 1. General safety requirements 1. Collateral standard. Medical electrical system safety
"Qiu" is referred to as "parallel standard".
The term "wood standard" includes wood-specific standards and common and juxtaposed standards used in conjunction with them.
The numbers of chapters, chapters, and bars of wood-specific standards correspond to the numbers of general standards. Modifications to the text of the General Standard require the use of the following terms.
"Replace". means that the chapter or section of the general standard is completely replaced by the text of this special standard;
"Increase". means that the wood standard for wood is added to the requirements of the general standard;
“Modification”. means that the chapter or section of the general standard is modified by the text of this special standard.
The bars, diagrams and tables added to the general standard are numbered from 101 to 101, the appendixes are AA, BB, etc., and the additions are aa), bb), etc.
Chapters and articles that have been prepared are marked with "
The standard normative part, which only provides additional information, it is not the object of the test.
This special standard does not mention the general standards, corresponding chapters, chapters, and articles. These articles, chapters, and articles of the general standard are applicable without modification.
(Although it may not be relevant); some part of the general standard, although it may be relevant, is not applicable and is clearly specified in the wood-specific standard.
The requirements of wood-specific standards take precedence over the requirements of general standards.
increase.
1.5 tied standards
In the series of safety requirements for medical electrical equipment, the collateral standards indicate that the general safety requirements apply to.
These preparations are described in informative appendix AA. Appendix AA is not a wood-specific sign.
A group of medical electrical equipment (for example. radiological equipment);
A special feature (eg electromagnetic compatibility) of all medical electrical equipment not specified in the general safety standards;
A juxtaposed standard is applicable to a special standard, then the special standard takes precedence over this juxtaposed standard.
2 terms and definitions
Except for the following, this chapter of the general standard applies.
2.1 Equipment parts, accessories and accessories
2.1.5
Applied part
replace.
Part of the normal used equipment.
A part of the body that should be in contact with the patient in order to perform the function of the device; o