SBS - The Best Value in QMS software

Identifying the Clean Room Requirements for a Medical Device in US and EU

A

Arati

#1
Identifying the clean room requirements for a medical device in US and EU

I need help in identifying the clean room requirements for medical device assembly and storage in US and EU based on the medical device classification in US and EU.
For example if our product is class II in US and class 2b in EU what are the clean room standards. How will I identify the requirements for clean room. I have done my round of searching was not able to find a exact requirement or guidelines which says for this classification of medical device it should have this clean room standards.

Please help
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
The guideline that you seek does not exist. There is no requirement for a specific class of cleanroom for a specific medical device class or code. The requirement instead is that the production environment must be controlled such that your medical devices are (within US FDA jurisdiction) safe and effective. (This differs slightly for EC rules, but the concept is the same.)

For devices that are provided sterile, the cleanroom requirement is determined by you based on your requirements to achieve product and process validation, and in particular from your sterilization validation and biocompatibility requirement. You must do whatever is required so that your devices are assuredly biocompatible per standard and sterile to the required probability, on a consistent basis.
 
A

ANDY-QA

#3
It is necessary of low class sterile medical device manufacturer (disposable) to operate in clean-room environment?

What is the guidelines for effective and save environment monitoring & control?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
It is necessary of low class sterile medical device manufacturer (disposable) to operate in clean-room environment?

What is the guidelines for effective and save environment monitoring & control?
Hello ANDY-QA and welcome to the Cove :bigwave:

I suggest that you carefully read MIREGMGR's post above, it answers your questions in a general way. In short - if you can consistently guarantee appropriate cleanliness and sterility without a clean room then you are allowed to do it.

You can use the QSR/cGMP regulations (US 21 CFR part 820) as your guideline for establishing and controlling an appropriate production environment. If you go down the clean room path, ISO 14644 series is relevant as well.

Good luck,
Ronen.
 
Thread starter Similar threads Forum Replies Date
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
Highground Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
T "Indication for Use" Identifying Specific Procedures US Food and Drug Administration (FDA) 2
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Audit NC - Not identifying our Customer Specific Requirements - TS16949 (7.3.6.3) General Auditing Discussions 7
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
V Identifying Significant Factors - Regression Analysis vs Correlation vs ANOVA vs DOE Quality Tools, Improvement and Analysis 7
F Requesting Help in Identifying Ford Suppliers Supplier Quality Assurance and other Supplier Issues 6
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
F Identifying Calibration on Small Tools (Measurement Equipment) General Measurement Device and Calibration Topics 2
C Identifying Response Times for CAPAs (Corrective and Preventive Actions) Nonconformance and Corrective Action 2
J Need help identifying nonconformities in internal audits Internal Auditing 2
A Identifying trends in QMS Nonconformities Quality Manager and Management Related Issues 1
B Looking for a Standard identifying SME's (Standard Measuring Equipment) General Measurement Device and Calibration Topics 1
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7
M Identifying Rework in Maintenance or Craftsman Operations Lean in Manufacturing and Service Industries 12
R Identifying "or equivalent" Test Equipment when written in a Procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
N Sheet Metal Identification Ideas - Best Practices for Identifying Raw Material Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom