Introduction to medical devices standards


BASIC SAFETY

Freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION

ESSENTIAL PERFORMANCE

Performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK

MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT – medical device)

Electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:

  1. Provided with not more than one connection to a particular SUPPLY MAINS; and
  2. Intended by its MANUFACTURER to be used:
    (a) In the diagnosis, treatment, or monitoring of a PATIENT; or
    (b) For compensation or alleviation of disease, injury or disability
  3. Know your standards
  4. Start with terms and definition
  5. Until you know terms and definition by hard always keep them open while reading
  6. Ask testing houses for guidance
  7. Not everything intended for hospital use should be certified towards IEC 60601-1
  8. Talk to NBs
  9. Perform FDA pre-submissions

What is harmonization?

In short, all harmonized standards which are used should cover the Essential Requirements. If gaps still remain, they must be filled with other verification.

Medical-device-certification

Medical-device-certification

What is the status of harmonization with MDR?

In June 2019, the European Commission issued the draft standardization request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746.

This request identified the first batch of standards for consideration for harmonization to the MDR and the European In Vitro Diagnostics Regulation (IVDR). There are a large number of standards in the mandate:

Priorities are being given to a handful of key standards, specifically those on quality systems (ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993-1), clinical trials (ISO 14155), and labelling (ISO 15523), including labelling for devices containing phthalates (ISO 15986).

So, what has changed?

On the paper – nothing.

In practice the NBs are scared of the transition and preferring to be on the safe side.

Some are even are trying to be more righteous than the Pope.

Sorts of outrages requests such as:

— that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.

Lessons learned from recent submissions to NBs.

Lessons learned from recent submissions to NBs.

Use latest EN version of 14897 there are some very important deviations from the international version.
(requirements from the international version are in bold)

Should you use BS EN ISO 14971:2019 or the older version?

According to BSI shop BS EN ISO 14971:2019 replaces BS EN ISO 14971:2012, on the other side it is not harmonized.

As I see it – it is part of the state of the art and the last revision should be used. Some very important definitions have been added. One of them is term Benefit.

 

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