Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds
This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS). It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC. IEC website states: “By purchasing this FDIS now, you will automatically receive, in addition, the final publication.” I can’t guarantee the same if you purchase elsewhere.
The standard IEC 60601-2-52 is at the 1st edition + Amendment 1 as an FDIS. The voting period is from 12 December 2014 thru 13 February 2015. It should be published as an IS if the vote is positive shortly after (forecasted to be published on 27 March 2015).
A1 changes include:
- Added definition of sub-clause 201.3.219 of an Adult and appropriate places through out the standard. Note the definition of an adults in this standard is at least 146 cm (57.48 inches = 4 ft & 9.48 inches) in length, at least a mass of 40 kg (88.18 lbs), and a body mass index of at least 17 (this is on the upper end of the under weight category but goes up to the high end of obese > 40 bmi).
- Added a requirement that hazards related to Patients taller than 185 cm should be considered in the Risk Management. (Sub-clause 201.4.2)
- Updated the Entrapment test tool of figure 201.103a) & b).
- Added a new symbol required to mark on a medical bed to identify what the requirements for the “adult” using the medical bed are. (Sub-clause 18.104.22.168.107) The symbol is to be placed on the medical bed in a prominent location and is to identify what an adult is, as defined in the standard in sub-clause 201.3.219.
- Added a requirement for the ifu to include a description of the intended Patient group(s). (Sub-clause 22.214.171.124.1e))
- Added a requirement that if the medical bed is limited to a specific group of patients to id that in the ifu. (Sub-clause 126.96.36.199.2e))
- Added a waning needs to be added to the ifu that incompatible side rails and mattresses can cause an entrapment hazard. (Sub-clause 188.8.131.52.2f))
- Updated figures 201.107 & 201.108 for medical beds with single or split/segmented side rails.
- Added a note related to sub-clause 184.108.40.206.2 on “static forces due to loading from persons” that support assemblies used in this test may be allowed to use a lower safety factor.
- Updated the Particular guidance and rationale section to incorporate “Adult” into this section of the standard for the Scope & Adult Definition. (Annex AA, Section AA.2, Sub-clause 201.1.1 & definition 201.3.201)
- Added to Annex AA, Section AA.2 Guidance & Rationale for Sub-clause 201.4.2 a list of possible hazards of medical beds to consider.
- Delete a paragraph in Annex AA, Section AA.2, Sub-clause 201.9.101 – Protection against inadvertent falls.