ISO 15223-1:2020 Symbols

[Sue789]

Can any one tell me when ISO 15223-1:2020 will be released?

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

 

[planB]

Sue,

the exact date is hard to predict. Since currently there is only an ISO/DIS 15223-1 and not even yet an FDIS, publication in 2020 is highly unlikely.

Hope this helps,

 

[LUFAN]

About 5 years too late... but ISO 15223-1:2021 is a published document

ISO 15223-1:2021

 

[REG12]

Follow up question on this guys, what is the effective date of 15223: 2021?
In other words when do the manufacturers will have start complying to the new revised labelling standard?

 

[LUFAN]

Follow up question on this guys, what is the effective date of 15223: 2021?
In other words when do the manufacturers will have start complying to the new revised labelling standard?

As far as I'm aware, it's immediately in-force like ISO 14971:2019. Nothing in ISO 15223 is auditable directly, rather other standards and regulations, ala ISO 20417:2021/MDR/IVDR/UDI, are going to call in the need for the symbols here and when that's the case they should be in accordance with ISO 15223:2021.

 

[REG12]

As far as I'm aware, it's immediately in-force like ISO 14971:2019. Nothing in ISO 15223 is auditable directly, rather other standards and regulations, ala ISO 20417:2021/MDR/IVDR/UDI, are going to call in the need for the symbols here and when that's the case they should be in accordance with ISO 15223:2021.

Hi Lufan, thanks for your input. That might put onus on the manufacturer to update their labelling which usually takes ages. I get the feeling BSI once published will put an effective date on their webpage.

 

[LUFAN]

Hi Lufan, thanks for your input. That might put onus on the manufacturer to update their labelling which usually takes ages. I get the feeling BSI once published will put an effective date on their webpage.

Not every standard has an implementation period. Generally, the QMS standards do, but the '14971s' of the world do not.

 

[MDRexpert]

Hi Everyone,

I am going through 15223-1:2020 standard. In the table to convey medical device information they have reference number, title, description, requirements and notes. I didn't come across anywhere if we should use the same format as described in the table. Is the description with the symbol required?