YY 0600.1-2007: Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices

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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 ventilator support devices, intended mainly for use
in home care BUT which could be used elsewhere (e.g. in healthcare facilities)
for appropriate patients for whom the use of a home-care ventilator complying
with YY 0600.2 is not required.
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)
GB7144-1999 Coloured cylinder mark for gases
GB 9706.1 Medical electrical equipment - Part 1: General requirements for
safety (GB 9706.1-2007, IEC 60601-1:1988 + Amd1:1991 + Amd2:1995, IDT)
GB/T 19974-2005 Sterilization of health care products - General requirement
for characterization of a sterilization agent and the development, validation
and routine control of a sterilization process (ISO 14937:2000, IDT)
YY/T 0316-2003 Medical devices - Application of risk management to
medical devices (ISO 14971:2000, IDT)
YY 0461-2003 Breathing tubes intended for use with aneasthetic apparatus
and ventilators (ISO 5367:2000, IDT)
YY 0466-2003 Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied (ISO 15223:2000, IDT)
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)
YY 1040.1-2003 Anesthetic and respiratory equipment - Conical connectors
- Part 1: Cones and sockets (ISO 5356-1:1996, IDT)
ISO 5356-2 Anesthetic and respiratory equipment - Conical connectors -
Part 2: Screw-threaded weight-bearing connectors
ISO 5359 Anesthetic and respiratory equipment - Low-pressure hose
assemblies for use with medical gases
ISO 5362 Anesthetic reservoir bags
ISO 7396-1 Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum
ISO 15001 Anesthetic and respiratory equipment - Compatibility with oxygen
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 0600.1-2007 (YY0600.1-2007)
Description (Translated English)	Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C46
Classification of International Standard	11.040.10
Word Count Estimation	24,290
Date of Issue	2007-01-31
Date of Implementation	2008-02-01
Quoted Standard	GB/T 4999-2003; GB/T 4332-1985; 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 15001; IEC 60601-1-8-2003
Adopted Standard	ISO 10651-6-2004, MOD
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 home respiratory support equipment for basic safety and essential performance requirements without the use of the device for compliance YY 0600. 2 home ventilator patients, mainly used in home care can also be used in other places (such as health care sector). 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.