I work for a company that makes custom batteries. We have designed a battery for a medical device. How does 13485 treat a component like the battery for risk management and classification. It is an accessory?

thanks.

I defer to the expert below!

:applause:

I think you're pointing to the wrong documentation (and concept). ISO 13485 is a process, quality management system standard. It says nothing about classification and only cites risk management because it knows that regulations asks for it. ISo 13485 not even mention the word accessory.

What you're looking for are the regulations. For example, the medical device directive applies to the medical device and it's acessories, and accessories are to be treated as medical devices on their own. From the consolidated version (http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/cons_vers_93-42-eec.pdf):

Article 1
Definitions, scope
1. This Directive shall apply to medical devices and their accessories.
For the purposes of this Directive, accessories shall be treated as
medical devices in their own right. Both medical devices and accessories
shall hereinafter be termed devices.

(b) ‘accessory’ means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with
a device to enable it to be used in accordance with the use of the
device intended by the manufacturer of the device;


The relation with risk management is: the accessory is a componente of the system and thus has to be taken into consideration relative to the risk management of the device. As you manufactures only the battery, my suggestions would be:

- make a risk management of the battery taking into consideration the intended use, environment, etc.,

- help you client manufacturer with the information he needs about the battery to complete his device risk management file.

Another aspect that you can look at as a battery manufacturer is system parity, in this case risk management system parity (See my discussion in this thread for more info on that - http://elsmar.com/Forums/showthread.php?t=26591)

The battery would be considered a COMPONENT, an item required as part of the finished device.
An ACCESSORY would be an item that could be used with the finished device, but not required for it to function.

Phil

Batteries are considered as ACCESSORY of a medical device - refer section 1.2 of Guidance document (http://ec.europa.eu/enterprise/medical_devices/meddev/2_1-1___04-1994.pdf)

I have read the document, I still think that the battery is a component, see 1.1B. (page 4) My assumption is that this battery is part of the finished device and is a requirement for the use of the device.
The guidance talks about a battery charger as an accessory, this agree with.

Phil

Thanks for the help,
sorry if my question bounced through several standards mmantunes. I did not want to list every standard,element and clause in regards to this.


The battery powers a portable defibulator. So if it goes, the patient can go too! I have not gotten to which federal regulations it may fall under. Anyone here that can point me in the right direction?

I think I have this figured out. if the battery is mounted inside a unit, it is a component. If external and can be removed, it is an assessory. Make sense? :bonk:

I think you almost hit the point:

There are to minor things to consider in addition:

one:
What does it mean remove?
Remove with the help of a tool such as a screwdriver?
Remove by soldering?

--> My proposal: remove without any specific tool

two:
The intended use of the batteries needs to be "replacement of batteries in specified medical devices"
Whereas specified means: brand, type, article, capacity etc.


Kind regards