Sterilization using beta radiation

chris1price

Trusted Information Resource
#1
I have a supplier using beta radiation to sterilise a device. While ISO11137 does not mention beta radiation, are the validation and dose setting methods it describes applicable to beta radiation?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
D What is your experience with FDA using "mixed load" i EO sterilization Other Medical Device Related Standards 1
shimonv Using sterilization data obtained from batch release for CE submission EU Medical Device Regulations 11
S Aseptic Processing - Maximum SAL using Aseptic Processing for Sterilization Other ISO and International Standards and European Regulations 4
validationspec LDPE for EO Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 2
B Gamma Sterilization Other Medical Device Related Standards 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
chris1price Contract Sterilization Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 5
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
R Scientific Operating Procedures For Sterilization Practices in India PSA/2012/1 Other Medical Device Regulations World-Wide 0
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 6
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
Z EN 868-8 "required tests" - Rigid sterilization containers Other Medical Device Related Standards 0
Judy Abbott Increase the maximum allowable dose for E-beam sterilization Reliability Analysis - Predictions, Testing and Standards 2
H EO Sterilization Validation - Sterility Testing and Load Configuration Other Medical Device Related Standards 3
A Reprocessing, Cleaning, Disinfection and Sterilization Validation EU Medical Device Regulations 4
W EO sterilization and pallets Other Medical Device and Orthopedic Related Topics 4
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
W EO sterilization - what about the pallet? Other Medical Device Related Standards 1
B Sterilization of a custom medical device Other Medical Device and Orthopedic Related Topics 1
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
G Pyrogen Test - Sterilization Validation - MDR 2017/745 Other ISO and International Standards and European Regulations 6
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
M Informational FDA Preps for Device Shortages as Another Sterilization Facility Will Close Medical Device and FDA Regulations and Standards News 0
M Informational FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices Medical Device and FDA Regulations and Standards News 0
P Sterilization Subcontractor of OEM ISO 13485:2016 - Medical Device Quality Management Systems 6
H Frequency of shelf life/sterilization/bench studies conducted on a medical device Other Medical Device Related Standards 1
T ISO 10993-7 - Ethylene oxide sterilization residues Other Medical Device Related Standards 1
J Contract Sterilization - Our company is a contract manufacturer Manufacturing and Related Processes 8
F Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137) EU Medical Device Regulations 2
Ed Panek Sterilization vs Disinfection - Wearable bandages that report a health metric via Bluetooth CE Marking (Conformité Européene) / CB Scheme 3
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 2
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
K Moist Heat Sterilization worldwide Requirements and Regulations Other Medical Device Regulations World-Wide 1
H Max and Min Load Determination for Steam Sterilization of Liquds EU Medical Device Regulations 1
Q Use of parts in gamma sterilization validation - Reprocessing implants EU Medical Device Regulations 1
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
I EO sterilization out of specification and correction Other Medical Device Regulations World-Wide 1
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
D Ethylene Oxide Sterilization aeration Manufacturing and Related Processes 1
H Change of a medical device sterilization dose - New 510(k) necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Studies conducted on the amount of autoclave sterilization of a PEEK implant Other Medical Device and Orthopedic Related Topics 1

Similar threads

Top Bottom