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Clean
Room Environment For Medical Devices - ISO 14644
ISO 14644-2:2015 - Part 2: Specifications for
testing and monitoring to prove continued compliance with
ISO 14644
ISO 14644-3:2005 - Part 3: Test methods
ISO 14644-4:2001 - Part 4: Design, construction and
start-up
ISO 14644-5:2004 - Part 5: Operations
ISO 14644 – parts #2 : ISO 14644-6: 2004 - Vocabulary
ISO 14644-7:2004 - Part 7: Separative devices (clean air
hoods, glove-boxes, isolators and mini-environments)
ISO 14644-8:2013 - Part 8: Classification of air
cleanliness by chemical concentration (ACC)
ISO 14644-9:2012 - Part 9: Classification of surface
cleanliness by particle concentration
ISO 14644-10:2013 - Part 10: Classification of surface
cleanliness by chemical concentration
No part 11 in draft
ISO 14644-12:draft - Part 12: Classification of air
cleanliness by nanoscale particle concentration
ISO 14644-13:draft - Part 13: Cleaning of surfaces to
achieve defined levels of cleanliness in terms of particle
and chemical classifications
ISO 14644-14:draft - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration
ISO 14644 Became live in December 2015. Thus it forms the
latest guideline standard/s for clean rooms.
The clean room environment is defined
further with its Occupancy states
If it is as built: condition where the installation
is complete with all services connected and functioning
but with no production equipment, materials, or personnel
present
Before the use but at rest: condition where the
installation is complete with equipment installed and
operation in a manner agree upon by the customer and
supplier, but with no personnel present.
We will discuss more in future article/s on aspects of
maintaining and monitoring clean rooms.
| Selected airborne
particulate cleanliness classes for cleanrooms and
clean zones |
| ISO classification number (N) |
CLASS LIMITS
(particles/m3)
Maximum concentration limits (particles/m3 of air) for
particles equal to and larger than the considered
sizes shown below |
| |
0.1 um |
0.2 um |
0.3 um |
0.5 um |
1 um |
5um |
| ISO Class 1 |
10 |
2 |
|
|
|
|
| ISO Class 2 |
100 |
24 |
10 |
4 |
|
|
| ISO Class 3 |
1000 |
237 |
102 |
35 |
8 |
|
| ISO Class 4 |
10000 |
2370 |
1020 |
352 |
83 |
|
| ISO Class 5 |
100000 |
23700 |
10200 |
3520 |
832 |
29 |
| ISO Class 6 |
1000000 |
237000 |
102000 |
35200 |
8320 |
293 |
| ISO Class 7 |
|
|
|
352000 |
83200 |
2930 |
| ISO Class 8 |
|
|
|
3520000 |
832000 |
29300 |
| ISO Class 9 |
|
|
|
35200000 |
8320000 |
293000 |
|
Note: Uncertainties related to the
measurement process require that concentration data
with no more than three significant figures be used in
determining the classification level. |
Following applicable rules for the manufacture of notified
Medical Devices in India, from January 01, 2018 are
described briefly.
ENVIRONMENTAL REQUIREMENTS FOR NOTIFIED DEVICES
| Name of Device |
Type of Operation |
Grade |
ISO Class (At rest) |
|
Cardiac stent/Drug Eluting Stent |
Primary Packing and Crimping |
A |
5 |
| Washing, Ultrasonic cleaning & Drug
coating |
C |
7 |
| Assembly, Wrapping & Packaging |
D |
8 |
| Laser cutting, Descaling, Annealing &
Electro |
Well ventilated area |
9 |
|
Heart Valve |
Valve Packing |
A |
5 |
| Ultrasonic Cleaning & Visual
Inspection |
C |
7 |
| Frame & Disc Assembly |
C |
7 |
|
Intra Ocular Lenses |
Primary Packing & Sealing |
A |
5 |
| Final Inspection |
C |
7 |
| Power Checking & Final Cleaning |
D |
8 |
| Tumble Polishing & Lathe Cutting |
Well Ventilated Area |
9 |
|
Bone Cements |
Final Product Filling |
A |
5 |
| Sieving & Calcinations |
C |
7 |
| Powder Preparation, Granulation &
Drying |
D |
8 |
|
Internal Prosthetic Replacement |
Primary Packing |
A |
5 |
| Product Preparation |
C |
7 |
| Component Preparation |
D |
8 |
|
Orthopedic Implants |
Cleaning & packaging (to be sterilized
in factory premises) |
C |
7 |
| Cleaning & packaging (Non Sterile- to
be sterilized in Hospital) |
D |
8 |
| Cutting, lathing and Polishing |
Well Ventilated Area |
9 |
|
Catheters/ Ablation Devices/ I V Cannulae/Scalp Vein
Set Hypodermic Syringes/Hypodermic Needles/Perfusion
Set |
Assembly, Coating, Wrapping & Packing |
C |
7 |
| Component Preparation & Cleaning |
D |
8 |
| Molding |
Ventilated Area |
9 |
Also included are IUD, Tubal Rings, Blood
Bags, Suture, Staplers, Ligatures, Surgical Dressings &
IVD Medical devices (kit/reagents)
Specific details are given in Medical
Device Rules GSR78E on pages 200-201 of English version..
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