Standards Flashcards
Explain the process of risk management.
Risk management follows a step-by-step process that begins with risk analysis, followed by risk evaluation, risk control, and evaluation of residual risk. This is an iterative process, and the team should return to risk analysis and risk evaluation repeatedly to identify if there are new risks arising from the risk control measures put in place. Once the residual risks are judged to be acceptable – i.e. the benefits of the treatment outweigh the risks, then the company will prepare a risk management report to be submitted to the competent authority through a notified body.
Explain why manufacturers must meet the essential requirements of the
Medical Device Regulations if they are to market their device in the EU.
The device must satisfy the essential requirements if a CE mark is to be
awarded, and a CE mark is essential to allow the device to be sold in member states of the EU.
What is a harmonised standard?
A standard that has been written so that compliance with the requirements of the standard will also ensure compliance with the essential requirements. However, it is essential for a CE mark to be awarded that the essential requirements are followed in full, it is not enough to just rely on following the standard.
What are the four main types of standard
Material standards, device standards, testing standards and procedure standards
A material standard will cover the composition, processing, and mechanical properties of a particular material, such as wrought stainless steel, and will ensure that materials used in medical devices will be of consistent quality. Device standards give the standard dimensions, connections, testing, and methods to determine performance for a particular medical device. Testing standards give methods to be used to determine material properties or other performance of materials and devices, allowing consistent comparison of performance. Procedural standards cover quality control, risk management, and so on, and give details of the methods to be followed and documentation that must be submitted for verification. For example, the medical quality standard, ISO 13485, gives guidance to manufacturers on how to ensure that their products have consistent performance.
What is meant by the ‘manufacturer’ of a medical device?
The manufacturer is the “actual or legal person” responsible for design, manufacture, packaging and labelling of the device before it is put on the market under his own name.
From the medical electronic standard (BS EN 6061), explain how class II medical electronic equipment protects the patient from exposure to leakage currents.
Class II medical equipment has a double layer of insulation to protect the patient from exposure to high voltage sources of electricity, and typically includes a step down transformer and AC/DC converter so that the patient is only exposed to low DC voltages and currents.
What are the test standards?
Mechanical testing
Metallographic techniques
Corrosion testing
Polymer testing
