YY/T 0449-2018Ultrasonic Doppler fetal monitor (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0449-2009 "Ultrasonic Doppler fetal monitor", compared with YY 0449-2009, except for editorial changes The main technical changes are as follows.

--- Modified the definition of ultrasound Doppler fetal monitor (see 3.1, 3.1 of the 2009 edition);

--- Removed the content of the product category (see Chapter 4 of the 2009 edition);

--- Increased the temperature drift indicator of the contraction pressure value (see 4.6);

--- Modified the requirements for the storage record function (see 4.7, see 5.6 of the 2009 version).

The documents of our country that have a consistent correspondence with the international documents referenced by the standard norms are as follows.

GB-9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1:1988, IDT);

--- GB 9706.9-2008 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment (IEC 60601-2-37:2001, IDT);

--- YY 0709-2009 Medical electrical equipment - Part 1-8. General requirements for safety - Parallel standard. General requirements, medical Testing and guidance for alarm systems in gas and medical electrical systems (IEC 60601-1-8:2003, IDT).

Some elements of this standard may involve patents. The issuing organization of this standard does not assume responsibility for identifying these patents.

1 Scope

This standard specifies the terms and definitions, requirements, test methods and inspection rules for ultrasound Doppler fetal monitors.

This standard applies to ultrasound Doppler fetal monitor (hereinafter referred to as "instrument"), which uses continuous wave or pulse wave ultrasound Doppler Principle, continuous monitoring of the fetus during the perinatal period, and timely provide alarm information when an abnormality occurs.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of medical ultrasound diagnostic and monitoring equipment

GB/T 14710 Medical electrical requirements and test methods

YY 0709 Medical electrical equipment - Part 1-8. Safety general requirements. Parallel standard. General requirements, medical electrical equipment and medical Testing and guidance for alarm systems in electrical systems

YY/T 1142 Medical Ultrasound Equipment and Probe Frequency Characteristics Test Method

3 Terms and definitions

The following terms and definitions apply to this document.

4 Requirements