What the difference in ISO 10993-11:2006 and 2009?

R

RA-KAT

#1
Hello,

Im new to the Regulatory World and is stumped! Im working on GAP Analysis of standards and is trying figure out what are the changes to ISO 10993-11?

Thanks!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

According to ISO website, ISO 10993-11:2006 is the latest version and is in effect. I didn't see a 2009 version there.

Maybe I didn't understand your question.

Cheers,
Ronen.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
As an FYI for those unfamiliar with the ISO 10993 series of standards:

Wikipedia reference-linkISO_10993

Current list of the standards in the 10993 series:

* ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a 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 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
* ISO 10993-10:2002/Amd 1:2006 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

Withdrawn 10993 standards

* ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
 
R

RA-KAT

#4
I thought that also, however i found the BSI website stating this below:

Standard NumberBS EN ISO 10993-10:2009TitleBiological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivityStatusCurrentPublication Date28 February 2010
Replaces BS EN ISO 10993-10:2002


Hence, the confusion...

Thanks for your help!
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I thought that also, however i found the BSI website stating this below:

Standard NumberBS EN ISO 10993-10:2009TitleBiological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivityStatusCurrentPublication Date28 February 2010
Replaces BS EN ISO 10993-10:2002


Hence, the confusion...

Thanks for your help!
Hi,

Please note that "BS EN" versions and the like (which are typically just a reproduction of the orginal, denoting adoption by local / regional authorities), may have a different issue date (year) from the original ISO version, while in fact they have the same content.

Cheers,
Ronen.
 
S

Saratogasix

#6
I am also struggling with a similiar dilemma. I am conducting a gap analysis of tech files from an acquisition. The TFs had not been updated in quite a while and the biocompatibility was conducted using now out-of-date 10993 standards. I am looking for an analysis of the revisions and their impact on prior test results and essential requirements. Does anyone know of a resource that provides this?
 
K

KAJayne

#7
I am looking for the same thing! We have testing to ISO10993-5:1999 but need to show that it is equivalent (i.e we don't need to test more) to ISO 10993-5:2009. I have searched for a table comparison for ISO biocompat test and haven't found--will keep searching and will post if I ever find!
 

Marcelo

Inactive Registered Visitor
#8
Really, if you are using the standards for a regulatory purpose you need to buy them. If not, how can you be sure of your analysis?
 
K

KAJayne

#9
We have the current revision (we are a newer company)--the material we received from a supplier with a cert. I cannot find the old standard to do a comparison so trying to determine if our material is still okay or if we need to do testing to the new standard.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
We have the current revision (we are a newer company)--the material we received from a supplier with a cert. I cannot find the old standard to do a comparison so trying to determine if our material is still okay or if we need to do testing to the new standard.
Hi,

If you're trying to resolve a specific issue (related to a specific part of the standard), you could approach an accredited test lab and ask them for a formal gap analysis between that part's revisions. Those labs have copies of all the standard's parts, and if they've been around long enough (as some have), they would also have older versions on file. Any such serious lab would have personnel very familiar with the test methods and requirements, and able to easily point out any relevant gaps. They would also typically be able to suggest the easiest path towards updated compliance, should any significant gaps exist.

As a side note, a lot of companies I know don't actually hold a full set of the current ISO 10993 series (or even a full set of only the parts applicable to their device(s)) - as they have to rely on the services of a 3rd party test lab anyway. It's similar to the situation with IEC 60601.

Cheers,
Ronen.

PS I'm not affiliated with any accredited test lab whatsoever, though I could recommend a few, from my own experience, in a private message (to avoid advertisement in the forum).
 
Thread starter Similar threads Forum Replies Date
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
A ISO 9001:2015 - The difference between 6.1.1b and 6.1.1d - IMHO, d) implies b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M What is the difference between ISO 9000 and ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q What is the difference between MDD Annex II, Sec 3 and ISO 13485 ? ISO 13485:2016 - Medical Device Quality Management Systems 5
Sean Kelley What is the difference between IECQ HSPM QC 080000 and ISO 14001 ? Other ISO and International Standards and European Regulations 1
M The difference between PN-EN ISO 13485 and EN ISO 13485 CMDCAS ISO 13485:2016 - Medical Device Quality Management Systems 7
W Is there a difference between TS16949 and ISO/TS16949? IATF 16949 - Automotive Quality Systems Standard 5
X Definition What is the difference between appoint and designate in the context of ISO/TS 16949? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
L What is the the difference between the Gage R&R Nested Anova and ISO/REMCO N263? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C What difference(s) you see before and after ISO 9001 certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K Drawing Tolerance What is the difference between ISO 2768-mH and ISO 2768-mK? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R ISO 9001 and ISO 9004 - Can somebody briefly explain their difference? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Difference between MIL-STD-105 and ISO 2859 AQL - Acceptable Quality Level 2
E What is the difference between clause 6.2.1 and clause 6.2.2 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
signal The difference between ISO 10006:2003 and ISO 10006:1997 Other ISO and International Standards and European Regulations 6
A What is the difference between an ISO Section vs. ISO Element? ISO 13485:2016 - Medical Device Quality Management Systems 10
tsmith7858 When will people learn the difference between OHSAS and ISO standards? Occupational Health & Safety Management Standards 29
E ISO/TS 16949 Clauses 8.2.2.1 & 8.2.2.2 - What's the difference? Internal Auditing 13
D Difference between ISO 22000 certificate and HACCP certificate Food Safety - ISO 22000, HACCP (21 CFR 120) 4
tsmith7858 Difference between Food Safety Management Systems (ISO 22000 VS SQF) Food Safety - ISO 22000, HACCP (21 CFR 120) 2
V Difference between Customer Complaint and Service Call as in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
P What is the difference between ISO 17025 and ANSI Z540.3 ISO 17025 related Discussions 10
S ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP? ISO 13485:2016 - Medical Device Quality Management Systems 17
B Difference between ISO 9001:2000 and AAR M-1003 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Research vs. Design vs. Development in ISO 13485 - What is the difference? Design and Development of Products and Processes 4
C Difference between COPC (Customer Operations Performance Center) & ISO 9001 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R What is the difference between ISO 9001:1994 and ISO 9001:2000 versions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Auditor training - Is there a big difference between auditing ISO 13485 & ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
A Difference between a Device and Equipment - ISO 9001 Clause 7.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A The difference between Equipment and Device - ISO 9001 Clause 7.6 Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B What is the difference between ISO 9001:2000 and TS16949? IATF 16949 - Automotive Quality Systems Standard 8
U Difference between ISO 9001 and Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N ISO 22000 - PRPs and Operational PRPs - What's the Difference? Food Safety - ISO 22000, HACCP (21 CFR 120) 7
A Difference between ISO 9000:1994 & ISO 9000:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Z What is the difference between ISO 9001 and TS 16949? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R Whats the difference, ISO vs EN ISO Std's ISO 13485:2016 - Medical Device Quality Management Systems 6
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1

Similar threads

Top Bottom