JIS T 0601-1:2012 Transition and Deviations to IEC 60601-1:2005

On the 1st of June, 2012, Japan published its own version of IEC 60601-1:2005, under the title JIS T 0601-1:2012. The standard is listed under the category of "MOD" which means it is equivalent but with declared modifications. The modifications are summarized in Appendix JC which at this time appear to be only available formally in Japanese (an Engish version of the standard is not yet published). 

The standard has been given a transition period in the Japanese regulation until May 31, 2017. As with Europe, it is expected that that the actual transition period will be driven by particular standards, and most importantly, the updating of the numerous "essential requirement checklists" which are prepared to assist third parties to certify Class II devices according to the PAL regulation (similar to the system used in US under the FDA). These checklists make explicit references to standards, editions and clauses, so these will have to be updated to make way for the series based on the third edtion. It is also noted that third party certificates allowing sale have a validity of 5 years. The overall result is that it could be many years before the third edition is fully applied in Japan. On the other hand, those manufacturers that have to deal directly with the PMDA (generally, the higher risk or novel, new devices) will likely have to follow the May 31, 2017 date. 

The following table provides a list of deviations according to Appendix JC, as translated by MEDTEQ. Although the list has around 15 items, it turns out that the only significant technical change is the allowance to use JIS approved power cords.

During the translation process, it was noted that Appendix JC does not list all the changes in referenced standards from IEC/ISO to JIS versions. For example, under Table 22, IEC 60601-1 references IEC 60085 for insulation systems, in the JIS version this is replaced by JIS C 4003 (which itself is based on but not identical to IEC 60085). One interpretation is that compliance with JIS T 0601-1:2012 can only be claimed if all the referenced JIS standards are checked for deviations. That would be extremely cumbersome, and unlikely to have any real technical impact. Most likely, the ruling will be that overseas manufacturers will be allowed to use IEC 60601-1:2005 + Appendix JC, so only the items in Appendix JC, as shown below, need to be checked as formal deviations.  

Clause

Deviation type

Deviation details

Additional notes

3.7

Correction

“protection against hazards” is corrected to “protection against harm”

No practical change

4.2, Note 2

Correction

“… give rise to hazards … “ corrected to “… give rise to harm “

No practical change

4.2, Note 6

Addition

Additional note to say that there are many similar errors with respect to hazard and harm throughout the standard

No practical change

7.4.3

Change

JIS version allows the combination SI and alternate units in Table 1

No practical change

7.7.4

Addition

If the power cord is in accordance with JIS C 3306 or JIS C 3301, white colour is also acceptable (for the neutral conductor)

 Allows also JIS power cords

7.7.5

Addition

If the power cord is in accordance with JIS C 3306 or JIS C 3301, JIS recognized colours are also acceptable for the (active conductors)

 Allows also JIS power cords

8.4.2 c)

Correction

“… up to 2V” is corrected to “more than 2V”.

As already corrected in Amendment 1:2012 to IEC 60601-1:2005

8.8.3

Addition

Additional sentence before the test is applied to say that the “electrical switch” shall be closed

Listed as being no technical change. This may be intended to point out that the mains switch on the equipment should be “ON” before the test.

8.9.1.2

Addition

“MOOP use” is added to the title

No technical change (just intended to make it clear only for MOOP)

8.9.1.14

Addition

“MOOP use” is added to the title

No technical change (just intended to make it clear only for MOOP)

8.11.3.2

Addition

Power cord is in accordance with JIS C 3306 or JIS C 3301 is also acceptable for this clause. If the temperature of an external metal part which the cord can touch exceeds 60C, double insulated cords are not allowed.

 Allows also JIS power cords

9.2.2.2

Table 20

Addition

The source of the data in Table 20 is changed to JIS B 9711

No technical change, data in Table 20 remains the same

9.7.5

Correction

Delete the reference to “unmarked” for pressure vessels

No technical change.

In amendment 1 to IEC 60601-1, “unmarked” has been clarified to mean “no national certification”.  

11.1.1

Addition

According to Annex JC, the additional point is simply an example of mixing Class A, B and C materials together.

 

It is noted that the actual text replaces IEC 60085 with JIS C 4003. This standard is listed as equivalent to IEC 60085 with modifications, and assumed to be equivalent for practical purposes.

No technical change

13.2.10

Table 26

Note

Addition

Add a reference to IEC 60950-1 for the limits (as well as IEC 61010)

No technical change

16.1

Addition

Equipment complying with JIS standards is also permitted within a system.

If an isolation transformer is used, equipment with basic insulation only is also permitted within the system.  

To avoid conflict with local approvals which may use JIS standards which are not aligned or identical to IEC/ISO standards