YY/T 0882-2013Anaesthetic and respiratory equipment—Compatibility with oxygen (English PDF)

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.

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.

1 R range

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.