ISO 22612 Certification in India
ISO 22612:2005 · Resistance to Dry Microbial Penetration · typical timeline 3–8 weeks
ISO 22612 is the test standard for resistance to dry microbial penetration. Indian PPE, medical textile and workwear manufacturers need ISO 22612 test reports from an ISO 17025-accredited lab to sell to hospitals, government buyers and export markets (CE PPE Regulation, FDA). We scope the right test method, arrange accredited testing and compile the technical file. Cost: ₹40,000–₹2,50,000 depending on products and tests; timeline 3–8 weeks.
Get a fixed-price quote in 24 hours
Tell us your industry, headcount and location. No retainer, no hidden certification-body fees.
Who needs ISO 22612 certification
- Surgical gown and drape manufacturers (EN 13795)
- Clean-room garment suppliers to pharma and electronics
- Non-woven fabric producers
- Hospital linen and PPE tender bidders
ISO 22612 requirements in plain words
- Dry contaminated talc with Bacillus subtilis spores
- Vibration challenge and agar plate count
- Log reduction / penetration value
- Classification per EN 13795 performance levels
- Report for CE technical file
- Material lot traceability
Certification process
- Step 1Gap assessmentWe audit your current processes against the standard and list exactly what is missing.
- Step 2DocumentationPolicies, procedures, records and formats written for your plant, not copied templates.
- Step 3Implementation & trainingYour team trained on the floor; internal audit and management review done with you.
- Step 4Certification auditStage 1 and Stage 2 audit by an IAF-accredited certification body of your choice.
- Step 5Certificate & surveillanceCertificate issued; we support annual surveillance audits for the full 3-year cycle.
ISO 22612 certification cost in India
Indicative 2026 all-inclusive prices — consulting, documentation, training and the certification-body audit fee. No separate charges. Full cost breakdown →
| Company size | All-inclusive price |
|---|---|
| 1–2 products, single test | ₹40,000–₹85,000 |
| Product range (3–8 SKUs) | ₹85,000–₹2,10,000 |
| Range + full CE technical file | ₹2,10,000–₹2,70,000+ |
Documents required
- Product specification and material composition
- Sample plan and test request per standard
- ISO 17025 lab test reports
- Classification / performance level statement
- Technical file and labelling
- Production consistency records
Benefits
- Evidence for hospital, government and tender buyers
- Required input for CE marking of PPE / medical devices
- Accepted by export customers under ILAC MRA
- Reduces field failures and product liability
Frequently asked questions
- Is ISO 22612 a certificate?
- ISO 22612 is a test method standard; the output is an accredited lab test report and a classification, which we compile into your compliance file.
- Which labs in India test this?
- NABL-accredited textile and PPE labs (e.g. SITRA, NITRA, BTRA and private labs) cover these methods; we select by scope.
- How often is retesting needed?
- On material or design change; buyers typically ask for reports under 2–3 years old.
ISO 22612 consultants by city
- Baddi
- Ludhiana
- Mohali
- Chandigarh
- Delhi
- Gurgaon
- Noida
- Ahmedabad
- Mumbai
- Pune
- Bangalore
- Chennai
- Hyderabad
- Kolkata
- Indore
Written by Sahil Dubey, CISA — lead consultant, PraxisQ Consulting LLP. Reviewed October 2026.
Get a fixed-price quote in 24 hours
Tell us your industry, headcount and location. No retainer, no hidden certification-body fees.