WS/T 659-2019 in English

Interpretation of the core content of the standard

As an important technical specification in the field of medical monitoring equipment, this standard has established a technical framework for the full life cycle management of multi-parameter monitors. Its outstanding features are reflected in:

Detailed explanation of key technical indicators

Electrical safety testing system

The standard innovatively establishes a four-level current detection matrix:

• Ground leakage current: BF/CF type equipment is required to be ≤1mA (fault state)
• Patient auxiliary current: CF type equipment AC mode is strictly controlled to 0.01mA
• The detection method covers 6 fault simulation states

Performance parameter calibration specification

Implementation suggestions for medical institutions

Management structure construction

The standard requires the establishment of a three-level management organization:

• Decision-making level: hospital leaders bear leadership responsibilities
• Execution level: medical device management departments lead testing
• Operation level: using departments implement daily maintenance

Testing capability construction

Professional testing equipment is required:

• ECG simulators need to support arrhythmia signals
• Blood oxygen simulators should contain multiple oxygen dissociation curves
• Ambient temperature is controlled within the range of 5-40℃

Standard evolution analysis

This standard integrates the requirements of GB 9706.1 and GB 9706.25 for the first time, organically combining the general standards for medical electrical equipment with the special standards for ECG monitoring. Its technological breakthroughs are reflected in:

• New respiratory rate detection specifications (15-80 times/min)
• Detailed neonatal blood pressure detection requirements
• Establishment of a mandatory post-maintenance detection system