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YY/T 0882-2013: Anaesthetic and respiratory equipment. Compatibility with oxygen
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Anaesthetic and respiratory equipment. Compatibility with oxygen
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YY/T 0882-2013
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Basic data | Standard ID | YY/T 0882-2013 (YY/T0882-2013) | | Description (Translated English) | Anaesthetic and respiratory equipment. Compatibility with oxygen | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.10 | | Word Count Estimation | 38,372 | | Quoted Standard | YY/T 0316-2008 | | Adopted Standard | ISO 15001-2003, IDT | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the material composition of anesthesia and respiratory equipment and applications in contact with oxygen, under normal or single fault condition 50kPa gas pressure is greater than the minimum requirement and oxygen compatibility. T | YY/T 0882-2013: Anaesthetic and respiratory equipment. Compatibility with oxygen---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Anaesthetic and respiratory equipment. Compatibility with oxygen
ICS 11.040.10
C46
People's Republic of China pharmaceutical industry standards
Anaesthetic and respiratory equipment with oxygen compatibility
(ISO 15001.2003, IDT)
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope
2 Normative references 1
3 Terms and definitions
2 4 Cleaning
5 R Fire 2
6 Risk Analysis 2
Examples Appendix A (informative) cleaning step 4
A typical method of Annex B (informative) cleaning validation step 10
Annex C (informative) design considerations 12
Choose Annex D (informative) Material 17
The recommended method Appendix E (informative) quantitative analysis related to combustion and combustion products of non-metallic material 28
Annex F (informative) Fundamentals 33
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is identical with ISO 15001.2003 "anesthesia and respiratory equipment - Compatibility with oxygen."
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard by the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points.
This standard was drafted. Beijing Yi-An Medical Systems Co., Ltd., Shanghai Medical Device detection.
The main drafters of this standard. Li Yunfei, Fu Guoqing, Wang Wei, Wu Man stand.
Introduction
Whether pure oxygen or other medical gases and oxygen mixture, is widely used in the health care system. Because patients and caregivers often pick
It means a high risk of contact with oxygen, oxygen-rich environment if ignited, causing serious injury. Common Cause is ignited by the compressed gas generation
The presence of heat, hydrocarbons, and particulate contaminants will promote ignition. Some combustion products, especially some non-metal (such as plastic, rubber
Rubber, lubricant) is toxic. So when a problem occurs, is receiving medical gas pipeline system from oxygen patients are likely to be injured, even far
From the device.
Some devices use oxygen or oxygen equipment immediately as a device driver source if oxygen equipment malfunction, these devices may be
Damaged or not working properly.
Reduce or avoid these risks depends on a suitable material, cleaning step, select the correct design and construction of the equipment, in order to use
Under the conditions and oxygen compatible.
The standard for the safe use of oxygen system designed for use in oxygen-enriched environments and to establish the recommended minimum standards.
Appendix F contains the principle of some of the requirements of this standard description. Requirements and recommendations it contains this standard provides further explain
release. Behind the label is marked with chapters in terms of R listed in Appendix F of the corresponding Rationale. Understanding these principles is not only conducive requirements
Proper implementation of this standard, but also promote further amendments.
Specific standard device may refer to this standard, but may improve the minimum requirements in place.
Specific Standard equipment may provide some of the requirements of this standard apply to other non-medical gas oxygen.
Anaesthetic and respiratory equipment with oxygen compatibility
1 Scope
This standard specifies the anesthesia and respiratory equipment and material composition of oxygen in contact with the application, the gas pressure is higher than normal or 50kPa
Minimum requirements under a single fault condition with oxygen compatibility.
This standard applies to anesthetic and respiratory equipment, such as. medical gas pipeline systems, pressure reducer, terminal, medical supply unit, a flexible connection,
Meter apparatus, anesthesia workstations and ventilator.
This standard compatibility features include. cleanliness, flame retardancy, combustion and/or decomposition products toxicity.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
YY/T 0316-2008 medical device risk management to medical devices applications (ISO 14971.2007, IDT)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Adiabatic compression adiabaticcompression
No heat conduction or transfer of import compression system.
3.2
Auto-ignition temperature auto-ignitiontemperature
Under certain specific conditions, a material can spontaneously ignite temperature.
3.3
Lethal Concentration lethalconcentration
LC50
So that a group of young adult rats (male and female) short-term (24h or less) exposed to a gas (or gas mixture) at once,
14d within the gas concentration at least half of the mice died.
[ISO 10298.1995]
3.4
Oxygen index oxygenindex
In the mixed gas consisting of oxygen and nitrogen at 23 ℃ ± 2 ℃, just to support a material under specific test conditions of combustion
The minimum oxygen concentration [volume fraction (%) indicates].
[ISO 4589-2.1996]
3.5
Qualified technical personnel qualifiedtechnicalperson
Through education, training or experience between oxygen and other materials to understand the physical and chemical principles of personnel response.
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