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ISO 294 - Overview Docs
ISO 294 - Overview Docs
PREVIEW
Foreword
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. ISO shall not be held responsible for identifying any
or all such patent rights. Details of any patent rights identified during the
development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of
users and does not constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific
terms and expressions related to conformity assessment, as well as information
about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.
This third edition cancels and replaces the second edition (ISO 294-5:2011), which
has been technically revised.
A list of all parts in the ISO 294 series can be found on the ISO website.
Introduction
A survey of more than 10 raw material suppliers worldwide carried out from 2010 to
2013 clearly indicated that the preparation of plates which provide a suitable degree
of anisotropy requires plates with non-square shape to ensure a fibre orientation in
flow direction. Under the conditions of this study, the highest degree of anisotropy
was obtained using a plate with dimensions 120 mm × 80 mm × 2 mm. It can be
considered that plates longer than 120 mm will show at least as good results. Square
plates (e.g. 80 mm × 80 mm × 2 mm or even 150 mm × 150 mm × 2 mm) resulted in
problems sometimes independent of the size. Within this study, the plate with size
90 mm × 80 mm × 2 mm as required in the previous edition of this document did not
perform well in any case.
1 Scope
This document specifies a mould (designated the type F ISO mould) for the injection
moulding of plates with a preferred size of 80 mm × 120 mm and a minimum size of
80 mm × ≥90 mm and with a preferred thickness of 2 mm for single-point and multi-
point data acquisition. It has been found to provide the maximum anisotropic
properties, with only a slight sensitivity to the rate of injection. Whenever possible, a
two cavity mould is intended to be used. For the design of plastic parts, this will
provide upper and lower bounds for the tensile properties. Matching the plate
thickness to a given part thickness is not a suitable criterion because of the effect of
mould filling rate and part geometry on anisotropy.
Investigation of the anisotropy of materials is a special procedure intended to
provide guidance in the design of mouldings for end-use applications and is not
intended as a quality control tool.
In the injection moulding of thermoplastic materials, the flow of molten polymer can
influence the orientation of fillers such as fibreglass or the orientation of polymer
chains, resulting in anisotropic behaviour.
For the purposes of this document, the flow direction is defined as the direction from
the gate to the far end of the mould cavity and the cross direction as the direction
perpendicular to the flow direction.
The type F mould is not intended to replace the type D mould used to determine the
moulding shrinkage of thermoplastics.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only
the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
For the purposes of this document, the terms and definitions given in ISO 294-1
apply.
ISO and IEC maintain terminological databases for use in standardization at the
following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
Only informative sections of standards are publicly available. To view the full
content, you will need to purchase the standard by clicking on the "Buy" button.
Bibliography
[1] ISO 527-2, Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and
extrusion plastics
Total Posts: 32
Validation of Processes - Plastic Injection Moulding - ISO 9001 Clause 7.5.2
LRS IYER
Hi!
Validation of processes of ISO 9001:2000 tells thru 7.5.2 that if the results are apparent only when the
product use is started or subsequent verification of the result of the process could not reveal the
process conformity then that process needs to be qualified. My doubt is:
1. A plastic injection moulding process making an automobile part. Drawing is available. After the
process/production the operator/ supervisor is able check the product as per drawing. Is this process
need to be validated? If yes why?
2. A blow moulding process which is a combination of extrusion and blow moulding. a similar thing
that of No.1. Is this process need to be validated? If yes why?
3. an automobile chasis welding process for which the company is having checking method of
NDT(LPT). Is this process need to be validated? If yes why?
if these things are answred then I have some more doubts about the same clause applicability.
Sponsored Links
Post Number #2
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
Hello LRS IYER !
I don't know the answer, but there was similar thread if I remember.
Please check this one, and see if you find the answer.
http://elsmar.com/Forums/showthread.php?t=4670
http://elsmar.com/Forums/showthread.php?t=17211
Also scroll down to bottom of the page and see similar threads.
BR
György
gszekely
Post Number #3
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
I beleive the process output in all 3 cases can be verified by subesequent monitoring or measuring.
What do you think? Can you verify the process output for injection and blow molding and the welding?
How and when do you know your output is acceptable is the question?
Do you know your product is good before the customer (internal or external) puts it in use?
Regards,
Dirk
vanputten
Post Number #4
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
Maybe (not sure of the full set of requirements in your examples above. I agree with the advice given
by the members above.
Reference your design requirements/input documents with respect to the process of manufacture - can
they all be verified (e.g. product/quality characteristic confirmed by inspection/test) or do some require
validation (can't be fully verified or verification is too costly or destructive; confirmation that the
characteristic is consistently achieved under varying process conditions, actual and extreme)? A robust
process properly validated (and perhaps with well established process controls) can significantly reduce
or eliminate inspection and test.
Good luck.
Kevin
Kevin Mader
Post Number #5
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
My understanding of the element is that it is for parts that can't be inspected because, for example, the
only acceptable test is a destructive test. In such cases the process must be validated by means of
expendable samples or some other validation technique.
1. The part can be inspected. If there are surfaces which cannot be inspected and are still critical (such
as a completely or almost closed hollow part) then a sample may need to be sacrificed for a destructive
test.
2. Same as #1.
3. NDT means Non Destructive Test, which is not supposed to render the part unusable. Dyes,
ultrasound, magnetic particle, and xrays don't typically destroy the part. If it does, the test is called
Destructive Testing. Peel test, bend test, break/shear test...you get the idea I'm sure, so now I'm getting
off my soap box.
Jen Kirley
Post Number #6
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
Quote:
LRS IYER
Hi!
Validation of processes of ISO 9001:2000 tells thru 7.5.2 that if the results are apparent only when
the product use is started or subsequent verification of the result of the process could not reveal the
process conformity then that process needs to be qualified.
The clause is worded a bit differently. It says validation is required when "the product cannot be
verified by subsequent monitoring or measurement." It includes what you have listed above.
In your example, validation will not be required if a check on the dimentional parameters / weld
integrity is sufficient for your purpose.
However, normally it is found that in such cases, strength and appearance checks will also be necessary.
Strength checks, if required, will necessarily need process validation.
Even otherwise, validation of such processes is recommended as these fall under the catagory earlier
termed as 'special processes' - processes whose outcome is controlled by controlling the process
control parameters.
potdar
Post Number #7
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
Besides the drawings, there may be other specifications with mechanical properties. Normally, then is
the case of deciding (depending on the requirements of the specification) on NDT or destructive
testing. If a destructive is needed, the validation is necessary.
alekra
Post Number #8
Re: Validation of Processes - Plastic injection moulding - ISO 9001 Clause 7.5.2
Quote:
LRS IYER
Hi!
Validation of processes of ISO 9001:2000 tells thru 7.5.2 that if the results are apparent only when
the product use is started or subsequent verification of the result of the process could not reveal the
process conformity then that process needs to be qualified. My doubt is:
1. A plastic injection moulding process making an automobile part. Drawing is available. After the
process/production the operator/ supervisor is able check the product as per drawing. Is this process
need to be validated? If yes why?
2. A blow moulding process which is a combination of extrusion and blow moulding. a similar thing
that of No.1. Is this process need to be validated? If yes why?
3. an automobile chasis welding process for which the company is having checking method of
NDT(LPT). Is this process need to be validated? If yes why?
if these things are answred then I have some more doubts about the same clause applicability.
You can refer this Process validation Guidance document from GHTF. Though this document is
applicable for Medical devices, you can use this document for reference and for better understanding
of validation concepts. Also tell which processes have to be validated and which processes to be
verified.
Th
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post,
3. Use at your Own Risk.
Ajit Basrur
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