YY 0600.3-2007Lung ventilators for medical use—Particular requirements for basic safety and essential performance - Part 3: emergency and transport ventilators (English PDF)

Foreword

The general title of Y600 is "Special Requirements for Basic Safety and Main Performance of Medical Ventilators", which consists of the following parts.

--- Part 1. Household respiratory support equipment;

--- Part 2. Home ventilator for ventilator dependent patients;

--- Part 3. Respirators for emergency and transport. Other parts of Y600 will be formulated one after another.

--- Part 4. artificial breathing equipment;

--- Part 5. Pneumatic first aid resuscitation equipment.

This part is the third part of Y0600. It is modified to adopt the international standard ISO 10651-3.:1997 "Medical ventilator --- Part 3.

Specific requirements for ventilator for emergency and transfer ", the main differences between this part and ISO 10651-3.:1997 are as follows.

--- This section adjusts ISO 10651-2.:2004 Chapter 2 "Normative Reference Documents" to 1.101; Chapter 3 "Terms and Definitions" Adjusted to Chapter 2, consistent with the general standard number;

--- Article 10.2.1a) The ambient temperature range is modified to "unless stated otherwise by the manufacturer, the ambient temperature range is -18 ° C to + 50 ° C".

The main reason for revising this article is that it is difficult to implement this article at the current domestic level, but it is not appropriate to modify the original standard technology.

Technical parameters, so be sure to add "unless otherwise specified by the manufacturer" in this clause;

--- Article 36.202.2.1 was amended to "Unless the manufacturer indicates otherwise, the level will be changed from 3V/m to 30V/m". This article is amended The main reason is that the original standard requires an order of magnitude greater than general medical device products, making it difficult to achieve at the current domestic level.

Large, but it is not appropriate to modify the technical parameters of the original standard, so it is determined to add "unless stated otherwise by the manufacturer" in this clause Expression.

This section is based on GB 9706.1-2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) "Medical Electrical Equipment Part 1. Special requirements for general safety requirements (common standards), used in conjunction with GB 97.16.1, and with GB 976.1-2007 (IEC 60601-1. 1988 + Amd1..1991 + Amd2..1995, IDT) was implemented in the same period.

Chapter 36 of this part is juxtaposed with Z05505-2005 "Medical Electrical Equipment Part 1-2. General Safety Requirements Standard. Electromagnetic Compatibility-Requirements and Tests "implemented concurrently.

Appendix AA, Appendix BB, and Appendix CC of this section are informative appendices.

Introduction

This part of the Q600 is specific requirements for portable ventilator for emergency and transport. These devices must meet breathing Machine definitions (automatically augmenting or providing ventilation to a patient's lungs), but they are more often medically trained by people with varying degrees of training Out-of-hospital or home use.

This part of Y600 is a special standard based on GB 9701.1 "Medical Electrical Equipment Part 1. General Safety Requirements."

GB 970.1 is referred to herein as the "common standard." Common standards are all used or monitored by qualified personnel in general medical and patient environments The basic standard for the safety of medical electrical equipment, it also includes some requirements for reliable operation to ensure safety.

Common standards are used in combination with side-by-side and proprietary standards. Tiered standards include special technical and/or hazardous requirements and apply to all There are application equipment, such as medical systems, EMC, radiation protection for diagnostic X-ray equipment, software, etc. Specific standards apply to special equipment types, such as Such as medical electron accelerator, high frequency electric knife, hospital bed and so on.

For a description of the parallel and special standards, see GB 9.76.1-2007 in Chapter 1.5 and Chapter A2, respectively.

The numbering of chapters, chapters, and articles in this part of Y0600 is consistent with the general standards. Changes to the text of the General Standard and supplements to the Parallel Standard Charge, specified by using the following words.

--- "Replace" means that the chapter or section of the general standard is completely replaced by the text of this section.

--- "Additional" means that the relevant text in this section is new content (for example, bar, column item, note, table, figure) attached to the general standard.

--- "Modified" means that the existing content of the general standard has been partially modified.

In order to avoid confusion with the revised version of the General Standard itself, the chapters, bars, tables and figures added to this part of Q6000 are numbered starting from 101;

The supplementary columns are numbered by the letters aa) and bb); the supplementary appendixes are numbered by AA, BB, etc.

The clauses marked with an asterisk (*) in this section are described in Appendix AA.

2 Terms and definitions

Except for the following definitions, 1.3 of GB 9706.28-2006 and Chapter 2 of GB 9706.1-2007 apply.

The definition in 2.1.5 of GB 9706.1 should be modified as follows.