Standards Development

Scope

Clause 1 of the general standard[1] applies, except as follows:

201.1.1 Scope

Replacement:

This part of IEC 80601 applies to the general requirements for basic safety and essential performance of medical robots that physically interact with a patient with an impairment to support or perform rehabilitation, assessment, compensation or alleviation related to the patient’s movement functions, as intended by the manufacturer.

Note: A movement function is a function consisting of one or more of sensory, neuromusculoskeletal or movement-related body functions that comprise patient motor control.

A raca robot is a programmable electrical medical system (pems) with a level of autonomy greater than zero, comprising an actuated applied part, intended by its manufacturer to perform rehabilitation, assessment, compensation or alleviation

raca robots covered by this particular standard include but are not limited to:

 Exoskeletons or robotic orthoses for upper and lower limbs for assessment, rehabilitation, alleviation or compensation

 Robotic end-effectors for upper / lower extremities for assessment or rehabilitation

 Balance control equipment for assessment or rehabilitation

 Overhead robotic body weight support systems

 Robotic walkers  

 Robots intended to alleviate hemiplegic shoulder/ joint pain or spasticity through movement

 Continuous Passive Motion devices with a level of autonomy  

Note 1: Annex AA lists a couple of raca robot examples.

Note 2: This particular standard is primarily focused on human beings. It is recognized that this standard may be used for animal patients. As such the use of the risk management process may be necessary to address basic safety and essential performance for animal patients.

This particular standard does not apply to

 Devices that address activities of daily living (including active assisted living) but do not directly address patient movement functions (e.g. of fingers, arms, legs) are excluded, such as

o electric wheelchairs (use ISO 7176 (all parts)),

o personal care / service ROBOTs (use ISO 13482; 2014), e.g. feeding robots, robotic hoists, robotic bed

 Devices without a level of autonomyo E.g.  Continuous Passive Motion devices without a level of autonomy

 Devices which are covered by other standards:

o external limb prosthetic devices (use ISO 22523; 2006-10),

o diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33; 2022),

o stationary training equipment (ISO 20957 series) e.g. treadmills

If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

NOTE See also 4.2 of the general standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular basic safety and essential performance requirements for medical robots that physically interact with a patient with an impairment, to support or perform rehabilitation, assessment, compensation or alleviation related to the patient’s movement functions.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020, and IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202, 206, 208, 210 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601‑1:2005/ AMD2:2020 are referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term "this document" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.