ISO 20417 - Medical Devices — Information to be provided by the manufacturer

Marcelo

Inactive Registered Visitor
#1
ISO TC 210 is proposing a new standard - ISO 20417 - Medical Devices — Information to be provided by the manufacturer.

The objective of the standard is to set general requirements for information that the manufacturers have to provide to the user for a safe device use.

Right now, several product standards have requirements for information, and there's a lot of duplication. Having one standard that details general information requirements for all devices will enable product standards to call this standard, and then only have additional requirements for that particular device.
 
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Marcelo

Inactive Registered Visitor
#3
No timeline yet as it's a New Proposal. Ballot for the proposal ands in October. If accepted, a project will be created. Standard time for development is 36 months, as always.
 

Marcelo

Inactive Registered Visitor
#6
The idea is obviously based in EN 1441, but 1441 is focused on the directives. ISO 20417 will need to focus on both other standards (as one of the objectives is to reduce duplication) and yes, international regulations, as much as possible.
 

LUFAN

Involved In Discussions
#7
Bump of an old thread but looks like this set for publication as early as next month. ISO 20417

I stumbled upon a BSI presentation that mentioned some of the detail at the bottom. Not sure why this hadn't crossed my radar before now. I'm going to assume the revision of ISO 15223-1 will be published right behind it.

One point that stood out to me, what's the difference between catalogue number and a model number? Symbol shows a hash-sign. "Model number: To identify the model number or type number of a product. This symbol shall be accompanied by the model number or catalogue number of the product, adjacent to the symbol. " Found a draft revision of the 15223 document and it appears in that as well.

"5.8 Catalogue number - assigned to medical device, or a combination of medical devices or accessories - unique catalogue number shall be related to a single, defined product specification - Multiple catalogue numbers may be associated with a single model number " - ISO 20417:2021

Is that saying if Model type 123 had size A/B/C variants with their own catalogue numbers, it's expected to be on the label like?

#123
REF: A

#123
REF: B

or per the description in italics if just a catalogue?

REF: # C
 

ASteel

Starting to get Involved
#9
15223-1:2021
Model number

  • A model number may be used to represent a medical device, an accessory or a medical device family that have shared characteristics.
  • A model number may be associated with multiple catalogue numbers.
  • The model number may be identical to the catalogue number, when there is a single catalogue number represented by the model number.
Catalogue number
  • A medical device or accessory, or a combination of medical devices or accessories, may be identified with a catalogue number.
  • Each unique catalogue number shall be related to a single, defined product specification.
  • Multiple catalogue numbers may be associated with a single model number

The label of a medical device shall include....
2) a distinctive identification.
i) If a model number is used, it shall be identified by a text string (EXAMPLE: For an English label: ‘Model number xyz123’ or ‘model xyz123’); or
symbol IEC 60417-6050.
ii) The catalogue number shall be identified by a text string (EXAMPLE: For an English label: ‘Catalogue number xyz123’.); or symbol ISO 7000-2493 or symbol 5.1.6 from ISO 15223-1:—.

The company that I work for only has one number for our devices and uses the term "catalogue number/reference number" for identification, therefore the model number is not necessary.
 
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