YY 0600.2-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 2: Home care ventilators for ventilator-dependent patients

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Scope

GB 9706.1-2007, clause 1 applies, except as follows.
Modification:
This part of YY 0600 specifies the requirements for lung ventilators intended for
home applications for those patients who are dependent on ventilatory support.
Such ventilators are considered life-supporting equipment, are frequently used
in locations where driving power is not reliable, and are often supervised by
non-healthcare personnel with different levels of training.
This part of YY 0600 is not applicable to cuirass and “iron-lung” ventilators.
This part of YY 0600 is not applicable to ventilators intended only to augment
the ventilation of spontaneously breathing patients.
The requirements of this part of YY 0600 which replace or modify the
requirements of the general standards are intended to take precedence over
the corresponding general requirements.
1.101 Normative references
The provisions in following documents become the provisions of this part
through reference in this part of YY 0600. For the dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard; however, parties who reach an agreement based on this
Standard are encouraged to study if the latest versions of these documents are
applicable. For undated references, the latest edition of the referenced
document applies.
GB/T 4999-2003 Anesthetic and respiratory equipment - Vocabulary (ISO
4135:2001, IDT)
GB/T 5332-1985 Method of test for ignition temperature of flammable liquids
and gases (eqv IEC 60079-4:1975)
ISO 9919 Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter equipment for
medical use
ISO 15001 Anesthetic and respiratory equipment - Compatibility with oxygen
ISO 21647 Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas monitors
IEC 60601-1-8:2003 Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral standard: Alarm systems - Requirements,
tests and guidelines - General requirements and guidelines for alarm
systems in medical electrical equipment and medical electrical systems

Basic Data

Standard ID	YY 0600.2-2007 (YY0600.2-2007)
Description (Translated English)	Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 2: Home care ventilators for ventilator-dependent patients
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C46
Classification of International Standard	11.040.10
Word Count Estimation	26,290
Date of Issue	2007-01-31
Date of Implementation	2008-02-01
Quoted Standard	GB/T 4999-2003; GB/T 5332-1985; GB 7144-1999; GB 9706.1; GB/T 19974-2005; YY/T 0316-2003; YY 0461-2003; YY 0466-2003; YY 0505-2005; YY 1040.1-2003; ISO 5356-2; ISO 5359; ISO 5362; ISO 7396-1; ISO 8185; ISO 9360-1; ISO 9360-2; ISO 9919; ISO 15001; ISO 21647; IEC 60601-1-8-2003
Regulation (derived from)	Chinese industry standards for record 2007 of 4 (total of 88)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the ventilator-dependent patients using home ventilator requirements, the device is suitable for patients who rely on ventilatory support. Such equipment is life support equipment, and its frequent use of places of power source is often unreliable, and often in highly varying degrees of training under the supervision of non-medical use. YY 0600 This part does not apply to armored and the "iron lung" ventilators. YY 0600 This part does not apply only to increase ventilation in patients with spontaneous breathing ventilator. If YY 0600 the requirements of this part, replace or modify the general requirements of the standard part of the requirements take precedence over the corresponding general requirements.