10993-1:2009 what are the changes? Is the risk management according to 14971?

J

jayquality

#1
it seems that the 10993-1:2009 has been released
the title changed to 'Evaluation and testing within a risk management system'
from the toc i see an entire annex on risk management
anybody knows the changes?
is the risk management according to 14971?

i did not see this one coming, i have a 2008 draft that mentiones identical to the 2003 version

thanks
 
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#2
Re: 10993-1:2009 what are the changes?

This is a 'bump' hoping somene may be able to help out with this.

My Thanks in advance!
 
B

Burgmeister

#3
According to the little bit of intro inside the 'new' standard, it states that the text of 2009 is identical as the standard it replaces. The difference is that now it is a national standard as well as an international standard. In my case this means it has gone from EN ISO 10993-1 to BS EN ISO 10993-1.

What a great way to generate revenue!
 
J

jayquality

#7
still confused but looking at the document i got, it's a draft international standard ISO-DIS-10993.
on the other hand several document suppliers list it with the new title but all refer to 2006 and seem to be the same draft
maybe this revised version will be released later

title:
Part 1:
Evaluation and testing within a risk management system

the TOC:

Contents Page
Foreword ...........................................................................................................................................................iv
Introduction.......................................................................................................................................................vi
1 Scope.....................................................................................................................................................1
2 Normative references...........................................................................................................................1
3 Terms and definitions ...........................................................................................................................2
4 General principles applying to biological evaluation of medical devices.......................................3
5 Categorization of medical devices ......................................................................................................7
5.1 General ..................................................................................................................................................7
5.2 Categorization by nature of body contact ..........................................................................................7
5.2.1 Surface-contacting devices..................................................................................................................7
5.2.2 External communicating devices ........................................................................................................7
5.2.3 Implant devices.....................................................................................................................................8
5.3 Categorization by duration of contact.................................................................................................8
6 Biological evaluation process..............................................................................................................8
6.1 Material characterization ......................................................................................................................8
6.2 Biological evaluation tests ...................................................................................................................9
6.2.1 General ..................................................................................................................................................9
6.2.2 Test descriptions................................................................................................................................10
7 Interpretation of biological evaluation data and overall biological safety assessment ..............14
Annex A (informative) Biological evaluation tests ........................................................................................15
Annex B (informative) Guidance on the risk management process............................................................17
B.1 General ................................................................................................................................................17
B.2 Risk management process.................................................................................................................17
B.2.1 Risk analysis.......................................................................................................................................17
B.2.2 Overall residual risk/benefit evaluation ............................................................................................18
B.2.3 Biological evaluation report ...............................................................................................................18
B.2.4 Post-production information..............................................................................................................18
B.3 Testing and test reports......................................................................................................................19
B.4 Biological evaluation report ...............................................................................................................19
B.5 Conclusion..........................................................................................................................................19
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive (Add the reference and title of the Directive)...............................20
Bibliography.....................................................................................................................................................21
 

xcanals_tecno-med.es

Involved In Discussions
#8
Hello jayquality
note that the standard is already approved and published
and seeing the ISO DIS 10993-1 index does not corrrespond to the approval of the DIS (not include risk management) and that the EN ISO 10993-1/A1 will be the edition which include the DIS version (see the DIN page http://www.nafuo.din.de/cmd?artid=1...ailansicht&committeeid=54738899&languageid=en )

See below the reference included in the BSI web store:

--------------------------- http://www.bsi-global.com/Shop/Publication-Detail/?pid=000000000030106189 ----------
BS EN ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing

BS EN ISO 10993-1 has been updated and now contains informative annexes that identify the sections of the standard that conform to the Medical Devices Directives 93/42/EEC and 90/385/EEC, for medical devices and active implantable medical devices.

BS EN ISO 10993-1 is part of the ISO 10993 series that consists of the following parts, under the general title Biological evaluation of medical devices:

Part 1: Evaluation and testing
Part 2: Animal welfare requirements
Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Part 4: Selection of tests for interactions with blood
Part 5: Tests for in vitro cytotoxicity
Part 6: Tests for local effects after implantation
Part 7: Ethylene oxide sterilization residuals
Part 9: Framework for identification and quantification of potential degradation products
Part 10: Tests for irritation and delayed-type hypersensitivity
Part 11: Tests for systemic toxicity
Part 12: Sample preparation and reference materials
Part 13: Identification and quantification of degradation products from polymeric medical devices
Part 14: Identification and quantification of degradation products from ceramics
Part 15: Identification and quantification of degradation products from metals and alloys
Part 16: Toxicokinetic study design for degradation products and leachables
Part 17: Establishment of allowable limits for leachable substances
Part 18: Chemical characterization of materials
Part 20 Principles and methods for immunotoxicology testing of medical devices
Part 1 of BS EN ISO 10993 is a combination/harmonization of numerous international and national standards and guidelines concerning the biological evaluation of medical devices.

It is intended to be the overall guidance and requirements document for the selection of tests enabling evaluation of biological responses relevant to the safety of medical devices and materials.

Biological evaluation should be undertaken by competent risk assessors. BS EN ISO 14971 Medical devices. Application of risk management to medical devices should be referred to.

The role of BS EN ISO 10993-1 is to serve as a framework in which to plan such a biological evaluation that minimizes the number and exposure of test animals.

The protection of humans is the primary goal of ISO 10993.

The appropriate selection and interpretation of biological evaluation tests requires an understanding of the rationale behind such testing.

BS EN ISO 10993-1 has been updated and now includes:

An informative rationale for the use BS EN ISO 10993 Part 1
A flow chart to aid in the systematic approach to the biological evaluation of medical devices
Bibliography
This part of BS EN ISO 10993 describes
General principles governing the biological evaluation of medical devices
Categorization of devices based on the nature and duration of their contact with the body
Selection of appropriate tests.
BS EN ISO 10993-1 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests.

Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

Contents of BS EN ISO 10993 include:
Scope
Terms and definitions
General principles applying to biological evaluation of medical devices
Categorization of medical devices
Testing
Selection of biological evaluation tests
Assurance of test methods
Rationale
Flow chart to aid in ensuring a systematic approach to biological evaluation of medical devices
Bibliography
BS EN ISO 10993-1:2009 supersedes BS EN ISO 10993-1:2003 which has been withdrawn.

Bibliographic DetailStandard Number BS EN ISO 10993-1:2009
Title Biological evaluation of medical devices. Evaluation and testing
Status Current
Publication Date 31 July 2009
Cross References ISO 7405:1997, ISO 9000:2000, ISO 9001:2000, ISO 9004:2000, ISO 10993-3, ISO 10993-4:2002, ISO 10993-5:1999, ISO 10993-6:1994, ISO 10993-9:1999, ISO 10993-10:2002, ISO 10993-11:1993, ISO 13485:2003, ISO 13488:1996, ISO/IEC 17025:1999, 93/42/EEC, 90/385/EEC
Replaces BS EN ISO 10993-1:2003
International Relationships EN ISO 10993-1:2009 Identical, ISO 10993-1:2003 Identical
Draft Superseded 06/30106186 DC
Descriptors Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Biological hazards, Dental equipment, Dental materials, Implants (surgical), Clinical investigation instruments, Bioassay, Cytotoxicity tests, Contaminants, Compatibility
ICS 11.100.20 (Biological evaluation of medical devices)

ISBN 978 0 580 54186 5
Publisher BSI
Format A4
Delivery YES
Pages 26
File Size 1.567 MB
Price £ 120.00
 
Last edited:
J

jedplace

#9
ISO 10993-1:2009 is a completely new version of the standard with biological evaluation within a risk management process. I believe it is due to become a MDD Harmonised Standard in April 2010.

BS EN 10993-1:2009 that is available is identical to the 2003 version of the standard with the addition of an MDD ER table.

It is clearly beneficial to conduct the evaluation within a risk management process as it provides the basis for the selection of tests based on the level of information available as well as the nature and duration of contact.

Jed Place
 
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