Medical Grades_ Medical Device Regulations

Medical Grades_ Medical Device Regulations

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices."

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:
Device Class and Regulatory Controls

1. Class I General Controls

With Exemptions
Without Exemptions

2. Class II General Controls and Special Controls

With Exemptions
Without Exemptions

3. Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.

Details please refer to:

IEC60601-1-2 4th Edition published

IEC60601-1-2 4th Edition published

In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements.

Dates

For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance.

Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It's typically 3 years before accepted standards are required for new submittals.

In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe.

Changes

Following are some of the key changes in the 4th edition.

Use environments are split into three areas:

  • Professional Healthcare Facility Environment
  • Home Healthcare Environment
  • Special Environment (test levels specified in Annex E)

Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.

For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.

For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.

Immunity test levels increase

  • The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
  • Magnetic immunity at 30A/m
  • Conducted immunity at 6V in ISM bands
  • SD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
  • Voltage dips and interruptions at additional phase angles

In addition to these Immunity changes

  • Immunity levels (Table 9) are harmonized with IEC 60601-1-11
  • Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
  • Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
  • There is a procedure for continuing to test a product that is damaged by an immunity test signal

And Risk Management is expanded

  • Manufacturers will be required to submit a test plan and the risk analysis document before testing
  • Operating modes are based on risk analysis
  • Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
  • The risk management process is used to determine whether subsystem testing is allowed
  • The minimum separation distance are considered in the risk management process
  • Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file

Details please refer to: MET Labs