Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment (English Version)
Key changes | Requirements of the 2000 version | Requirements of the 2021 version |
---|---|---|
Scope of application | Only supplement the general standards | Replace the general standards and add basic performance requirements |
Definition of terms | 12 core terms | Added 16 technical definitions such as capacitive coupled high-frequency current |
Electromagnetic compatibility | Basic test requirements | Clearly define the acceptable criteria for temporary image interference |
According to 201.11.101.2, when the endoscope is used in conjunction with high-frequency surgical equipment:
The accompanying documents must include the following warning statement (201.7.9.2.2):
The following situations can be exempted from moisture pretreatment (201.5.7):
GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment has been changed from GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment.
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