If you are in the business of importing, manufacturing, and ultimately selling electrical devices within Australian markets then, no doubt, you’ve come across the EESS (Electrical Equipment Safety System), ACMA (Australian Communication and Media Authority) requirements for electrical safety and EMC compliance as well as Electricity Safety (Equipment Safety Scheme) Regulations.
Now, navigating your way around this can be tricky especially given recent changes to the applicable standards and regulation. We have, personally, seen a lot of organisations get caught out in the defining their equipment, where their equipment relates to the applicable standards, as well as the EMC compliance. Throw into this mix devices with WIFI, Bluetooth, or other transmitting elements and the particular requirements around this becomes exponentially complex.
Let’s start with ERAC. The EESS applies to “in scope” electrical equipment. This means
- Greater than 50 V AC RMS or 120V ripple-free DC (Extra-low voltage) and
- Less than 1000V AC RMS or 1500V ripple-free DC (high voltage),
Recent changes to AS/NZS 4417.2, the standard defining the applicability of ERAC (Electrical Regulatory Authorities Council) requirements, means there’s been some changes to not only what is “in scope” but also to the equipment levels.
In-scope electrical equipment must be designed, or marketed as suitable for household, personal or similar use.
The first challenge is that in some jurisdictions the definition of what is in-scope changes. For example, in Queensland it is immaterial whether the equipment is also designed or marketed for commercial or industrial purposes.
This has also been reflected with recent changes to Victorian regulation.
For the better part the level of equipment is defined within the Australian Standard AS/NZS 4417.2. The level of equipment mandates the required testing, notification, and documentation requirements needed to show and maintain compliance to EESS and ultimately earn that valuable “C-tick” RCM mark.
The lines get a little hazy with some devices we have been helping our clients with lately. As the technology grows and develops it’s becoming harder to “pigeon hole” these devices into the levels. Non-compliance to this present some serious business risks to your organisation. You don’t want a level 3 device being declared as a level 1 and subsequently miss the required testing. Similarly, you don’t want to pour your hard-earned dollars into un-necessary compliance testing.
Further to this, from a commercial equipment aspect, the alignment of AS/NZS 4417.2 with current regulations means the requirements for “prescribed” commercially supplied equipment have changed. In our opinion, for the better, as the harmonisation adds a level of uniformity. Most commercial equipment ends up domestic applications eventually.
For those of you importing devices, don’t be fooled into thinking that just because a device is “CE” marked, that it meets all the compliance requirements. Even though many standards are now harmonised to avoid these issues, there are many that are not.
Another trap we have seen our clients fall into is importing a device that has already been registered on the national database. This does not give you immediate compliance with EESS requirements. There is still some work that needs to be done for this.
There are other mandated requirements outside of the AS/NZS 4417.2 standards that your device may need to meet, such as minimum safety requirements (a whole other Australian Standard), to gain and maintain compliance to the EESS, regardless of the level of equipment.
ACMA mandates a whole other set of requirements around EMC (electromagnetic compatibility) and energy transmission that we can also help you to navigate through, but we’ll discuss this in another article.
If you want to know more about what we have discussed or would like some help with your organisation, please contact us or visit below links for more info:
medical device compliance
manufacturing compliance services
We are more than happy to help you with your queries in a confidential, no-obligation, discussion.