ISO 19227 Validation Cost

Chrisx

Involved In Discussions
#1
I recently reviewed ISO 19227 and I'm a bit surprised at the extent of testing. It would appear to require testing with statistically valid sample sizes for: visual, LAL, TOC, THC, Inorganic contaminants, and cytotoxicity. I believe we could waive bioburden and particulate, since we don't perform the final sterile packaging of the device. When I consider 2-runs for an OQ and 3 for a PQ, times 6-tests, times a valid sample size, then the numbers rapidly grow. Does anyone have any experience with the cost to validate to this standard? It is probably the right thing to do, but the cost would appear to be outside what most manufacturers are likely to absorb. I suspect compliance to this standard is very low. Do any of you have experience justifying a very low sample size? In my experience, many manufacturers use a single unit for many biocompatibility tests. I'm not suggesting that's right, but I'm not aware of the ISO 10993 series providing any guidance on sample size.
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Chrisx,

ISO 19227:2018 is not prescriptive, but extensively points out in section 4.2. that the design, validation and monitoring of the cleaning process, including chosen acceptance criteria and test methods should be based on risk management activities. In this context, the standard lists the criteria/endpoints you are mentioning, but frequently starts with wording similar to "If the purpose is to demonstrate cleanliness regarding [criterion], ...", so it is up to your assessment which criteria you regard as significant to achieve your defined level of cleanliness.

Furthermore, the standard is rather vague on sampling, section 4.5 "When appropriate (for example, when establishing the reproducibility of the process), sampling plans can be based upon statistically valid rationale for number of test specimens"

In case you are talking about a terminal cleaning process, then the relevant endpoints and acceptance criteria are often linked to ISO 10993-1:2018. While this standard is indeed not very explicit about sample size, it implies that biocompatibility-related tests can be regarded as "type tests" (n=1). This is explicitly spelled out in ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications section - screenshot from the table of contents:

1612988890107.png

Number of OQ runs: "NOTE 3 In some cases the relevant limits of the process might be both the lower and upper limits, while in other cases only one of these limits might be relevant."

PQ runs: it is up to your risk assessment whether you require re-testing all your OQ criteria to demonstrate cleaning process reproducibility and consistency.

Hope this helps,
 

Chrisx

Involved In Discussions
#3
Thanks for the additional information. I had not previously thought of biocompatiblity as a type test, however I agree that a sample size of n=1 is common.
 
Thread starter Similar threads Forum Replies Date
Edward Reesor ISO 19223 Discussion (Help) Other Medical Device Related Standards 0
chris1price MDSAP and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
D ISO 13485 Contained NC ISO 13485:2016 - Medical Device Quality Management Systems 3
K Compliance Obligations 6.1.3 of ISO 14001 ISO 14001:2015 Specific Discussions 3
V EN ISO 10993-1, Category of surface device by nature of body contact Other Medical Device Related Standards 2
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Ron Rompen ISO 9001 Sanctioned Interpretations and FAQs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
S Do ISO certs require an Apostille? ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 2
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
R What are the new changes in EN ISO 11137-1:2015+A2:2019? Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Sidney Vianna ISO 14001 News ISO 14001 Continual Improvement Survey ISO 14001:2015 Specific Discussions 0
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 30
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom