The differences between equipment and instrument based on ISO17025, FDA , and EUGMP standards are discussed below:
1. ISO 17025
- Equipment: ISO 17025 defines equipment as any device or apparatus used to carry out tests, measurements, or calibrations. It includes items such as balances, thermometers , pressure gauges, etc.
- Instrument: ISO 17025 defines an instrument as a specific type of equipment used to measure or control a & physical quantity or process. Instruments are typically more complex devices that require calibration and validation to ensure accurate and reliable measurements.
2. FDA (Food and Drug Administration)
- Equipment: The FDA regulations do not explicitly define equipment separately from instruments. Instead, they refer to both as "devices" that are subject to specific requirements for design control, manufacturing processes, labeling , etc.
- Instrument: Similarly to ISO 17025, the FDA does not distinguish between instruments and equipment in its regulations. Both terms are generally used interchangeably in the context of medical devices.
3. EUGMP (European Good Manufacturing Practice)
- Equipment: EUGMP guidelines define equipment as any machinery or apparatus used during the manufacturing process of pharmaceutical products. This includes items such as mixers, reactors, filling machines, etc.
- Instrument: EUGMP guidelines do not explicitly differentiate between instruments and equipment. However, they emphasize the need for proper calibration and validation of all measuring devices used in critical processes to ensure accuracy and reliability.
In summary, while ISO 17025 provides a clear distinction between equipment and instruments based on complexity and purpose, both FDA and EUGMP tend to use these terms interchangeably without specific definitions for each. However, all three standards emphasize the importance of calibration and validation for ensuring accurate measurements in various industries.
