SBS - The best value in QMS software

ASTM A967 Testing Interpretation - No Customer Requirements

R

rsmoot

#1
I'm looking for an interpretation on the ASTM A967 standard regarding "test requirements". I think one would need to read the actual text of the spec to be able to answer...

My question is " If a customer does not specify one of the 5 test methods (and efectively leaves it up to us), (putting on their purchase order only "Passivate per ASTM A967" Is testing actually "REQUIRED", or is it sufficient to say the item was passivated per that spec?

Now - I have to add - this is a technical question, not a question about what's right, or what the purchaser should be putting on the P.O.
Obviously, the right answer is to help the customer word the PO line correctly (for their needs) so they buy the right service, we document test appropriately, and validate it, etc.

I'd say this is a "theoretical question", but someone internally is actually proposing "not doing testing/validation" on the process, but still certifying it as done according to the spec.

Thanks for opinions.....
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello,

http://www.astm.org/Standards/A967.htm

ASTM A967
Abstract

This specification covers several different types of chemical passivation treatments for stainless steel parts. The treatments are the following: immersion treatment using nitric acid solutions, immersion treatment using citric acid solution, and electrochemical treatment. Immediately after the removal from the passivating solution, the parts shall be thoroughly rinsed, using stagnant, countercurrent, or spray washes, singly or in combination, with or without a separate chemical treatment for neutralization of the passivation media. The chemical reactions of the passivating media on the surface of the stainless steel shall be stopped by rinsing of the stainless steel part, with or without a separate neutralization treatment. A chemical treatment shall be applied which will accelerate the formation of the passive film on a chemically clean stainless steel surface. The passivated parts shall exhibit a chemically clean surface and shall, on visual inspection, show no etching, pitting, or frosting. The following tests shall be performed on each lot of stainless steel parts: water immersion test, high humidity test, salt spray test, copper sulfate test, and potassium ferricyanide-nitric acid test. A free iron test shall be used for the detection of free iron on the surface of stainless steel.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. Scope

1.1 This specification covers several different types of chemical passivation treatments for stainless steel parts. It includes recommendations and precautions for descaling, cleaning, and passivation of stainless steel parts. It includes several alternative tests, with acceptance criteria, for confirmation of effectiveness of such treatments for stainless steel parts.

1.2 Practices for the mechanical and chemical treatments of stainless steel surfaces are discussed more thoroughly in Practice A380.

1.3 Several alternative chemical treatments are defined for passivation of stainless steel parts. Appendix X1 gives some nonmandatory information and provides some general guidelines regarding the selection of passivation treatment appropriate to particular grades of stainless steel. It makes no recommendations regarding the suitability of any grade, treatment, or acceptance criteria for any particular application or class of applications.

1.4 The tests in this specification are intended to confirm the effectiveness of passivation, particularly with regard to the removal of free iron and other exogenous matter. These tests include the following practices:

(...)
I don't have the entire standard in front of me, but if a standard specifies both methods of achieving something and tests (whether voluntary or otherwise) for ascertaining that indeed this "something" was achieved, I think an unreserved declaration of "compliance with the standard" would be misleading if none of the tests were performed and/or acceptance criteria specified in the standard were not met. I think the right thing to do in such a case is to declare compliance with those sections of the standard that were followed and complied with.

Cheers,
Ronen.
 
R

Ray Kremer

#4
Sorry for the late answer here.

The requirement was worded ambiguously for a while, the committee has fixed that now. The intention is indeed to require one of the test methods be used. If it is not specified by the customer then it is up to you to choose which one to use. A967, being a "Standard Specification" rather than a "Standard Practice", is officially geared towards passing a test rather than following a procedure.

Now, does this mean that everybody passivating per A967 actually does so? I very much doubt it.
 
Thread starter Similar threads Forum Replies Date
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 2
M Packaging studies - ISTA vs ASTM CE Marking (Conformité Européene) / CB Scheme 0
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
N Database that lists labs accredited to ASTM / ANSI standards Various Other Specifications, Standards, and related Requirements 6
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
P What ASTM std is EC 93/42 MDD EQUIVALENT TO CE Marking (Conformité Européene) / CB Scheme 1
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 16
D ASTM C1064 Temperature Measuring Device General Measurement Device and Calibration Topics 2
K Troubleshooting Salt Spray (ASTM B117) Manufacturing and Related Processes 2
P Average Peel Strength - Interpretation of BS EN 868-5:2018 and ASTM F0088/F0088M Other Medical Device Related Standards 2
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 0
M Package Integrity Test ASTM F 2096 or ASTM 1929 Quality Assurance and Compliance Software Tools and Solutions 1
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
M Accelerated Ageing Test for Orthopedic Implants -- ASTM F 1980 or ISO 11607 or both are applicable ? Other Medical Device and Orthopedic Related Topics 2
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
M ASTM A6 Material Standard - Section Nominal Sizes Manufacturing and Related Processes 1
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
D Non ASTM Partial Immersion LGT emergent stem correction General Measurement Device and Calibration Topics 3
2 ASTM or ISO Specifications on Prints Other US Medical Device Regulations 2
M ASTM F 75-12 - Tensile properties Product castings ( 7.1 ) vs Casting alloys ( 7.2) Other ISO and International Standards and European Regulations 1
X Heat Treat - Verifying mechanical properties on heat treated material per the ASTM Manufacturing and Related Processes 6
M ISO / ASTM standards for Sampling Plans for Medical Devices Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Are ASTM F745 & ASTM F75 still valid? EU Medical Device Regulations 5
Q M-282 - Engineering Standard for Tolerances - Is it ASTM, DIN? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Correlation between ASTM & China's GB (Guobiao) / YY Standards China Medical Device Regulations 4
Ron Rompen Water Immersion Testing ASTM D870 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
E ASTM D3951 Part Marking Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M ASTM Stainless Steel Density Table Various Other Specifications, Standards, and related Requirements 1
S ASTM-D4000 & FORD "ZW" Call-Outs Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S ASTM-1965-98 (Reapproved 2009) has contradictory requirements? Other Medical Device Related Standards 2
P ASTM-F2096 Medical Package Testing Various Other Specifications, Standards, and related Requirements 1
T ISO 2409 / ASTM D3359 Paint Adhesion Other ISO and International Standards and European Regulations 8
T ISO/BS/DIN/EN/ASTM - Standards Equivalencies Other ISO and International Standards and European Regulations 3
Q ASTM Specification Revision Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Coke Reactivity Index (CRI) Testing Code Interpretation: ASTM D5341-99 (2004) Various Other Specifications, Standards, and related Requirements 2
P ASTM Standard, Stainless Steel angle that has been rejected because it is not ?square Manufacturing and Related Processes 2
N Protein content limit in condom according to ASTM standard Other ISO and International Standards and European Regulations 3
S Magnetic Resonance ? Testing to ASTM F2503-08 Other Medical Device Related Standards 6
L Product numbers & sources for ASTM D3359 adhesive tape Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
E Withdrawal of ASTM F-745 07 CE Marking (Conformité Européene) / CB Scheme 5
J Salt Spray Failure Question (ASTM B 633 and B 117) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
D ASTM E165 Liquid Penetrant Equivalent Other ISO and International Standards and European Regulations 6
S ASTM F2179-02 Glass Scratch Test Procedure Requirements Manufacturing and Related Processes 1
G Free ASTM Standards? Recent Court Ruling making their standards free? Various Other Specifications, Standards, and related Requirements 10
S ASTM Standard for Hardness Spec for 6063 T6 Aluminum Extrusions Various Other Specifications, Standards, and related Requirements 1
N FDA vs ASTM - Limitations of Powder Content in Gloves Other Medical Device Regulations World-Wide 3
S Followups to ASTM F2554-10? Surgical Navigation System Accuracy Other Medical Device Related Standards 1
J Galvanizing and ASTM A90 - Coating Weight Test Compliance Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1

Similar threads

Top Bottom