General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
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GB/T 16886.17-2005
Scope
This part of GB/T 16886 specifies the method for determining the allowable limit of leachable substances in medical devices, the purpose of which is to obtain a proper assessment of the application of the standard and the limit for which no standard has been established. This section describes a systematic process by which identified risks from toxic substances in medical devices are quantified. This section does not apply to devices that do not come into contact with patients (such as in vitro diagnostic devices). This section does not deal with certain chemical substances not derived from device exposure, such as food, water, air.
GB/T 16886.17-2005 history
2005GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances