YY 0600.2-2007Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (English PDF)
医用呼吸机 基本安全和主要性能专用要求 第2部分：依赖呼吸机患者使用的家用呼吸机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
January 31, 2007
Implementation date
February 1, 2008
Scope
YY 0600.2-2007 is the English-translated version of 医用呼吸机 基本安全和主要性能专用要求 第2部分：依赖呼吸机患者使用的家用呼吸机.
YY 0600.2-2007 is the Chinese pharmaceutical industry standard that sets the requirements for the home care ventilator used by patients who depend on ventilatory support.
It is the second part of the YY 0600 series and applies together with GB 9706.1-2007, whose clauses it replaces or modifies, and it treats such ventilators as life-supporting equipment often used where the power supply is unreliable and often supervised by people who are not healthcare staff, covering the delivered ventilation and its accuracy, the alarms and the battery, the breathing system and its connections, and the information supplied.
It does not apply to cuirass and iron lung ventilators. Issued on 31 January 2007, it has applied since 1 February 2008.
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Document preview — YY 0600.2-2007
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword5
- Introduction7
- 1 Scope9
- 1.101 Normative references9
- 2 Terms and definitions11
- 3 General requirements13
- 4 General requirements for tests13
- 5 Classification13
- 6 Identification, marking and documents14
- 7 Power input19
- 8 Basic safety categories20
- 9 Removable protective means20
- 10 Environmental conditions20
- 11 Not used21
- 12 Not used21
- 13 General21
- 14 Requirements related to classification21
- 15 Limitation of voltage and/or energy21
- 16 Enclosures and protective covers21
- 17 Separation22
- 18 Protective earthing, functional earthing and potential equalization22
- 19 Continuous leakage currents and patient auxiliary currents22
- 20 Dielectric strength22
- 21 Mechanical strength22
- 22 Moving parts22
- 23 Surfaces, corners and edges23
- 24 Stability in normal use23
- 25 Expelled parts23
- 26 Vibration and noise23
- 27 Pneumatic and hydraulic power23
- 28 Suspended masses23
- 29 X-ray radiation23
- 30 alpha, beta, gamma, neutron radiation and other particle radiation23
- 31 Microwave radiation24
- 32 Light radiation (including lasers)24
- 33 Infra-red radiation24
- 34 Ultra-violet radiation24
- 35 Acoustical energy (including ultrasonic)24
- 36 Electromagnetic compatibility24
- 37 Locations and basic requirements24
- 38 Marking, accompanying documents24
- 39 Common requirements for category AP and category APG equipment25
- 40 Requirements and tests for category AP equipment, parts and components thereof25
- 41 Requirements and tests for category APG equipment, parts and components thereof25
- 42 Excessive temperature25
- 43 Fire prevention25
- 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility26
- 45 Pressure vessels and parts subject to pressure27
- 46 Human errors28
- 47 Electrostatic charges28
- 48 Biocompatibility28
- 49 Interruption of the power supply28
- 50 Accuracy of the operating data29
- 51 Protection against hazardous output29
- 52 Abnormal operation and fault conditions33
- 53 Environmental tests34
- 54 General34
- 55 Enclosures and covers34
- 56 Components and general assembly34
- 57 Mains parts, components and layout37
- 58 Protective earthing - Terminals and connections38
- 59 Construction and layout38
- 101 Alarm systems38
- 102 Appendix of general standard39
- Appendix AA (Informative) Rationale40
- References46
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 2 of YY 0600, which modifies and adopts the international standard ISO 10651-2:2004 "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home-care ventilators for ventilator-dependent patients". The main differences between this part and ISO 10651-2:2004 are as follows:
- In this part, adjust the clause 2 "Normative references" of ISO 10651-2:2004 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 "not used";
- 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".
1 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
2 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 4999-2003, GB 9706.1, IEC 60601-1-8 AND the following terms and definitions apply to this part of YY 0600. Addition: […]
2.101 Airway pressure
Pressure at the patient connection port.
2.102 Applied part
Part of the equipment which is in normal use - Necessarily comes into physical contact with the patient for the equipment to perform its function, or - Can be brought into contact with the patient, or - Needs to be touched by the patient, or - All parts of the ventilator intended to be connected to the ventilator breathing system.
Note: Adapted from GB 9706.1-2007, 2.1.5. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 46 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 4999-2003Anaesthetic and respiratory equipment Vocabulary
- GB/T 5332-1985Method of test for ignition temperature of flammable liquids and gases
ISO 9919 · ISO 15001 · ISO 21647 · IEC 60601-1-8:2003
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Related Standards
GB/T 4999-2003 — Anaesthetic and respiratory equipment Vocabulary
YY 0600.3-2007 — Lung ventilators for medical use—Particular requirements for basic safety and essential performance - Part 3: emergency and transport ventilators
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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YY 0600.2-2007
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