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Standards assistant

Ask about ESD and cleanroom standards in plain English. Get a short answer, what it means for your area, and where Sucatec can help.

Guidance only. The assistant summarises standards in its own words and can make mistakes. It does not certify products or sites. Check the current edition of the standard and confirm with your quality team or auditor.
Quick reference

The standards people ask about most

StandardCoversIn short
ANSI/ESD S20.20ESD control programmePeople, surfaces, packaging, marking and checks
IEC 61340-5-1ESD control programme (IEC)The IEC equivalent, common in Europe
ANSI/ESD S541, IEC 61340-5-3ESD packagingBags, trays and containers
ANSI/ESD S1.1, S6.1, S4.1Wrist straps, grounding, worksurfacesLimits and test methods
ISO 14644-1Cleanroom classesParticle limits by class
ISO 14644-2, -5Monitoring and operationsKeeping a room in control
EU GMP Annex 1Sterile manufactureGrades A to D for pharma
IEST-RP-CC004WipersHow wiping materials are evaluated
ASTM test methodsGloves, flooring, resistanceFor example D6319, D3578, D257, F150
JEDEC J-STD-033Moisture-sensitive partsDry packing and floor life

Prefer to read first? See ESD standards at a glance and ISO 14644 classes explained.

Cleanroom classes

ISO, Fed Std and GMP side by side

Three ways to name a cleanroom. Read the chart, then see the full guide.

Cleanroom classes compared: ISO 14644-1, Federal Standard 209E and EU GMP grades, with particle limits THREE WAYS TO NAME THE SAME CLEANLINESS ISO 14644-1Current standard Fed Std 209EWithdrawn 2001 EU GMP Annex 1Pharma grades 0.5 micronMax per m3 ISO 3 Class 1 — 35 ISO 4 Class 10 — 352 ISO 5 Class 100 Grade A (and B at rest) 3,520 ISO 6 Class 1,000 — 35,200 ISO 7 Class 10,000 Grade B in operation, C at rest 352,000 ISO 8 Class 100,000 Grade C in operation, D at rest 3,520,000 ISO 9 No equivalent — 35,200,000 Cleaner at the top. Fed Std counts are per cubic foot, shown here as per cubic metre.
Rough equivalence only. GMP grades also set microbial limits. Your quality team maps grades and classes for your site.

Read the full comparison

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