ISO 10993 (Biological Compatibility) Approved Materials

J

jsscshaw88

#1
Hi,

I am looking for

1. ISO10993 approved velcro. Something looks like:


2. ISO10993 approved arm band. something looks like:


or ISO 10993 approved woven elastic material:


Please help!

jess
 
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Marc

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#2
Re: ISO 10993 Approved Materials

Since you're looking for these and cite sources, why are you asking? Are none of the companies ISO 10993 (Bio-Compatibility) registered/certified? I'm not personally familiar with ISO 10993 so I personally have no idea. Maybe some of the others here do.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello and welcome to the cove :bigwave:

No such thing as generic ISO-10993-approved. Compliance with ISO 10993 is always related to a certain type of contact (e.g. with intact skin, blood path etc.) and contact duration. Any supplier stating broad (non application specific) "ISO 10993 compliance" is probably intentionally being vague to promote sales.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Certification with respect to ISO 10993 (Biological Compatibility)

According to Wikipedia:
WikiPedia said:
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of a medical device prior to a clinical study[citation needed]. These documents were preceded by the Tripartite agreement and is a part of the harmonisation of the safe use evaluation of medical devices[citation needed].
Wikipedia reference-linkISO_10993

As far as I can tell, this is a standard you can claim compliance with, but is not a standard that a company can be certified to. I found this, for example:
MedTechInsider said:
<snip> Stereolithography (SL) resins WaterShed XC 11122 and ProtoGen 18420 from DSM Somos reportedly are the only SL resins to meet ISO 10933 standards for use in medical device applications. The clear, water-resistant Watershed XC 11122 and white, ABS-like ProtoGen 18420 resins are certified to ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitisation) and ISO 10993-10 (irritation). <snip>
(Emphasis mine)

What do they mean by "Certification" in this context? It reads as if the product is "certified".

Can anyone help in better understanding ISO 10993 and how it plays into the ISO standards "product line"?

Definitions of "Certified", anyone?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Certification with respect to ISO 10993 (Biological Compatibility)

According to Wikipedia:

Wikipedia reference-linkISO_10993

As far as I can tell, this is a standard you can claim compliance with, but is not a standard that a company can be certified to. I found this, for example: (Emphasis mine)

What do they mean by "Certification" in this context? It reads as if the product is "certified".

Can anyone help in better understanding ISO 10993 and how it plays into the ISO standards "product line"?

Definitions of "Certified", anyone?
Sure, these materials comply with certain parts of 10993, but not with the standard as whole because that would be either meaningless or impractical to achieve in ~99% of the cases.

By certification they probably mean that they have available 3rd party lab test reports stating testing according to ISO 10993-X and the results.

Cheers,
Ronen.

PS The phrasing "...meet ISO 10933 standards for use in medical device applications" is just the type of vague marketspeak I was referring to. At least in this case the next sentence clarifies that compliance is only partial; however, not all potential buyers are educated enough to understand the difference, therefore I would consider such phrasing as slightly inappropriate. [BTW, is the typo in standard name in the source?...]
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Re: Certification with respect to ISO 10993 (Biological Compatibility)

<snip> BTW, is the typo in standard name in the source?... <snip>
If you mean in the thread title, it's an "abbreviation" I came up with. There are a heck of a lot of ISO 10993 "sub" standards. It appears to be like the ISO 900x series of standards where only one of which is one a company can register/certify to.

Or is there a spelling typo somewhere?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
This is a *lot* (from Wikipedia):

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials
ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-12:2007 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Re: Certification with respect to ISO 10993 (Biological Compatibility)

If you mean in the thread title, it's an "abbreviation" I came up with. There are a heck of a lot of ISO 10993 "sub" standards. It appears to be like the ISO 900x series of standards where only one of which is one a company can register/certify to.

Or is there a spelling typo somewhere?
No, I referred to "...meet ISO 10933 standards for use in medical device applications." in the text you quoted. Please note it says 10933 instead of 10993.

Sorry for not being clearer in the first place... :eek:
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Re: Certification with respect to ISO 10993 (Biological Compatibility)

<snip> BTW, is the typo in standard name in the source? <snip>
It was a copy and paste from MedTechInsider. Not surprising. The big companies have "copy" people writing these things up. I see so many mis-spellings and typos these days I'm not the least surprised. I do it myself from time to time. I personally blame it on "Old Timers Disease"... I was on a major multinational corp site the other day and saw 2 "adn" (should be "and") typos on the home page.
 
J

jsscshaw88

#10
Re: Certification with respect to ISO 10993 (Biological Compatibility)

Hi,

FDA needs materials to be approved against ISO10993. My device needs above mentioned armbands and velcro to work with.

jess
 
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