Medical Device Labeling Standards

General requirements iso 14971 2012 medical devices application of risk management to medical devices.

Medical device labeling standards.

Labeling regulatory requirements for medical devices gpo 017 012 00327 3 2 75 pb 86 184348 as 11 95. Medical device labeling is considered as important as classifying a product or creating an insulation diagram. 801 127 medical devices. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system.

These regulations specify the minimum requirements for all devices. In iec 60601 1 labeling is deemed a critical component of a medical device 1 the standard provides comprehensive requirements for medical device marking and labeling. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. An interlaboratory comparison of analytical methods for ethylene oxide pb 86.

Essential principle 13 of schedule 1 of the therapeutic goods medical devices regulations 2002 the regulations outlines the requirements for information that must be provided. Iso 15223 1 2012 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. The general labeling requirements for medical devices are contained in 21 cfr part 801. General device labeling 21 cfr part 801 use of symbols.

801 128 exceptions or alternatives to labeling requirements for medical devices held by the strategic national stockpile. It also lists symbols that satisfy the requirements of iso 15223 1 2012. All medical devices supplied in australia must meet the relevant essential principles for safety and performance to ensure the device is safe and performs as intended. 801 122 medical devices for processing repacking or manufacturing.