PD IEC/TR 60601-4-3:2018

What is PD IEC/TR 60601‑4‑3- Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 about?

PD IEC/TR 60601 is a standard that discusses medical electrical equipment. PD IEC/TR 60601‑4‑3 provides the best industry guidance on considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements to ensure safety against hazardous situations.

PD IEC/TR 60601‑4‑3 is the third subpart of the fourth part of a multi-part series that specifies a series of recommendations

developed by an expert working group of IEC subcommittee 62A in response to questions of

interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series.

The object of PD IEC/TR 60601‑4‑3 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards.

Note: There might be other acceptable solutions that are not reflected in this document. The reader is reminded that, although a majority of the National Committee members of IEC/SC 62A have approved publication of this document, the contents remain the opinion of the expert members having participated in the drafting of the document.

These recommendations/interpretations are the result of considerations by this group of nominated experts and have not been formally adopted through any National Committee voting procedure. Distribution is only for information.

Who is PD IEC/TR 60601‑4‑3- Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 for?

PD IEC/TR 60601‑4‑3 on the considerations of unaddressed safety aspects in the third edition of IEC 60601-1 is relevant to:

• Test laboratory for Medical electrical equipment
• Medical electrical equipment manufacturers
• Developers of subsequent editions of IEC 60601-1
• Other entities responsible for the assessment

Why should you use PD IEC/TR 60601‑4‑3- Considerations of unaddressed safety aspects in the third edition of IEC 60601-1?

62A established a procedure under which working group (WG) 14 would develop recommendations regarding problems of interpretation or application of IEC 60601-1. WG 14 is made up of experts with particular expertise in testing according to the requirements of IEC 60601-1. Many of the experts on WG 14 are employed by test laboratories with a long history of applying IEC 60601-1 to medical electrical equipment.

 PD IEC/TR 60601‑4‑3 provides you with a preliminary review of the areas where changes are possible and so the outcome.

With compliance and obedience to PD IEC/TR 60601‑4‑3, you can assist those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards.

What’s changed since the last update?

PD IEC/TR 60601‑4‑3:2018 supersedes IEC/TR 60601‑4‑3:2015, which is withdrawn. PD IEC/TR 60601‑4‑3:2018 has made an addition of 47 new recommendations compared to the previous edition IEC/TR 60601‑4‑3:2015.