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Hospital-Grade Infection Control

Class B Sterilisation
— the Gold Standard
of Safety

At Aspen Dental Care, every reusable instrument is sterilised in our Class B autoclave to EN 13060 — the highest standard recognised by European and Indian infection control bodies. Not Class N. Not Class S. Class B.

EN 13060 Certified
Spore-Tested Monthly
🫙
🌡️
Temperature
134 °C · 3 bar
⏱️
Cycle Duration
18 min + drying
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Sterility Level
SAL 10⁻⁶ (surgical)
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Cycle Records
Printed & logged
Bacterial elimination 100% — every cycle
Class BEN 13060 Standard
134°CSterilisation Temperature
SAL 10⁻⁶Surgical Sterility Level
100%Logged Every Cycle

The Technology

What is Class B
Sterilisation?

EN 13060 is the European standard that classifies small steam sterilisers into three types: Class N (basic — unwrapped solid instruments only), Class S (intermediate — some hollow/wrapped loads), and Class B (the highest — validated for all instrument types including porous, hollow, and wrapped loads). Class B replicates the full sterilisation capability of a large hospital autoclave in a small-format machine.

At Aspen Dental Care, we use only Class B autoclaves because every instrument that enters your mouth deserves surgical-grade sterility — regardless of its complexity. This protects you against cross-infection from bacteria, viruses (including hepatitis B/C and HIV), prions, and bacterial spores.

EN 13060 Class B
All Instrument Types
Prion-Level Safety
Printed Cycle Records
134°C ✓ CLASS B
EN 13060
Validated Daily
Class B Autoclave Cycle
Pre-vacuum → Steam penetration → 134°C hold → Dry → Print record — every single use.

Understanding the Standard

Class N vs Class S vs Class B
— Why the Difference Matters

Not all dental clinics sterilise to the same level. The EN 13060 classification system makes the difference clear and measurable.

🔶
Class N Autoclave
The basic level. Only validated for solid, unwrapped instruments — no hollow or porous items. Cannot guarantee sterility for complex dental instruments. Common in low-cost clinics. We do not use Class N.
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Class S Autoclave
Intermediate level. Can handle a specified range of loads declared by the manufacturer — but not necessarily all types. Capability varies widely between machines. Not validated for all wrapped or porous loads. We do not use Class S.
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Class B Autoclave
The highest standard. Validated for all instrument types: solid, hollow (A & B), porous, single-wrapped, double-wrapped, and complex surgical instruments. Equivalent to a large hospital autoclave. Mandatory pre-vacuum phase removes all air for complete steam penetration. This is our standard.
Capability Class N Class S Class B (Aspen)
Solid, unwrapped instruments
Hollow instruments (Type A) Partial
Hollow instruments (Type B — e.g. handpieces)
Porous loads (e.g. textiles, gauze) Limited
Wrapped / packaged instruments Partial
Pre-vacuum (air removal) Partial ✓ — Mandatory
Drying phase included Sometimes ✓ — Always
Printed cycle validation Optional ✓ — Every cycle
Suitable for dental handpieces
SAL (Sterility Assurance Level) 10⁻⁴ (basic) 10⁻⁵ (intermediate) 10⁻⁶ (surgical grade) 🏥

Step-by-Step

Our Full Sterilisation
Workflow — Every Instrument

From the moment an instrument is used to the moment it is placed in your mouth again — every step is controlled, validated, and traceable.

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Collection & Pre-Clean
Used instruments are collected wearing heavy-duty gloves. Gross contamination is removed at point-of-use before transport to the decontamination area.
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Ultrasonic Cleaning
Instruments are placed in an ultrasonic bath with enzymatic solution. 40 kHz sound waves dislodge biofilm, blood, and debris from every crevice — including lumen interiors inaccessible by hand.
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Inspection & Packaging
Each instrument is inspected under magnification, lubricated if required, then sealed in medical-grade sterilisation pouches with dual chemical indicators — one internal, one external.
♨️
Class B Autoclave Cycle
Packaged instruments run through the full Class B cycle: pre-vacuum air removal, steam at 134°C for 3.5 min at 3 bar, followed by a validated drying phase to prevent recontamination from moisture.
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Print, Log & Store
Every cycle is automatically printed and logged with date, time, temperature, pressure, and cycle number. Sterile packs are stored in sealed, dry cabinets and tracked until point of use.
⏱️
Total Decontamination Cycle: Approximately 90 Minutes
From dirty to sterile-packaged and logged. No instrument is ever reused without completing the full validated cycle — no exceptions, no shortcuts.

Scope of Sterilisation

Every Reusable Instrument.
No Exceptions.

Class B is the only standard capable of sterilising the full range of instruments used in modern dentistry. Here is exactly what goes through our autoclave.

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Dental Handpieces
High-speed and low-speed handpieces are hollow instruments containing lubricated bearings and turbines. Class N and S autoclaves cannot sterilise these. Our Class B autoclave validates full steam penetration through every internal component after mandated flushing.
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Endodontic Files & Reamers
Root canal instruments have complex fluted surfaces and extremely fine tips. Residual pulp tissue deep in the flutes is eliminated only through the combination of ultrasonic cleaning and Class B steam penetration.
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Periodontal Scalers & Curettes
Scaling instruments contact subgingival tissue and calculus — areas of high bacterial concentration. All scalers, curettes, and ultrasonic tips are individually packed and Class B sterilised between every patient.
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Surgical Instruments
Extraction forceps, elevators, retractors, and implant surgical kits are double-wrapped and loaded in dedicated surgical trays, then processed through the Class B cycle with full validation before every surgical appointment.
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Orthodontic & Restorative Tools
Pliers, band pushers, bite registration trays, and matrix systems are sterilised between patients. Disposable alternatives are used wherever possible, and reusable items always go through the full Class B cycle.
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Impression Trays & Accessories
Metal impression trays that cannot be disposed of are individually cleaned, inspected for pitting, and Class B sterilised. Single-use plastic trays are used wherever clinically appropriate and never reprocessed.

Quality Assurance

How We Validate That
Sterilisation Actually Works

A Class B autoclave is only as trustworthy as the validation programme that proves it is working correctly. We run a rigorous, multi-layered validation protocol — every day.

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Biological Indicators (Spore Tests)
Geobacillus stearothermophilus spore strips are processed through the autoclave and sent to an independent laboratory monthly. Spore kill confirms the cycle is achieving true sterilisation — not just high temperature.
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Chemical Indicators (Every Pack)
Every sterilisation pouch contains a dual Class 4 chemical indicator — an internal strip that changes colour only when the correct temperature and time combination are achieved inside the pack.
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Bowie-Dick / Helix Test (Daily)
A Helix test device simulates the worst-case hollow instrument geometry. Passed first thing every morning before any patient instruments are processed — confirming air removal and steam penetration are functioning correctly.
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Printed Cycle Records (Every Run)
The Class B autoclave automatically prints a validated cycle strip showing cycle number, date, time, chamber temperature, pressure, and hold-time. Records are filed and available for regulatory inspection at all times.
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Annual Qualified Person Validation
The autoclave undergoes annual performance qualification testing by a trained validation engineer, including leakage rate, air detector, steam penetration (vacuum test), and thermometric verification — to EN 13060 Annex B.
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Instrument Traceability Log
Each sterilised pack is labelled with the cycle number and sterilisation date. Patient records link the instruments used in each appointment to the specific autoclave cycle — enabling full traceability in the unlikely event of a cycle failure.

Single-Use Commitment

What We Never Reuse —
No Matter What

Where single-use is clinically possible, we use it. These items are disposed of after every patient — never reprocessed, never shared.

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Needles & Syringes
All local anaesthetic needles and cartridges are single-use, opened in front of you, and disposed of in approved sharps containers immediately after use. Never recapped, never reused between patients.
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Gloves
Nitrile examination gloves are changed between every patient and whenever a contamination event occurs within a procedure. Non-sterile and sterile gloves are both maintained in adequate supply and never reused.
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Masks & Face Shields
Fluid-resistant surgical masks and face shields are single-use. Masks are changed between patients and immediately if contaminated during a procedure. FFP2 respirators are used for aerosol-generating procedures.
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Suction Tips & Saliva Ejectors
All suction tips, saliva ejectors, and air-water syringe tips are single-use disposable. The internal suction tubing is flushed with disinfectant between every patient to prevent backflow contamination.
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Prophy Cups, Brushes & Paste
Prophylaxis cups, brushes, and polishing paste dispensed for your appointment are single-use. Communal paste pots are not used — your portion is dispensed fresh from a sealed tube for your appointment only.
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Surface Barriers & Bibs
Light handles, headrest covers, bracket table covers, and patient bibs are protected with single-use barrier film or disposable covers, changed between every patient contact and disposed of as clinical waste.

Beyond the Autoclave

Our Clinic Environment —
Controlled at Every Level

Instrument sterilisation is the core — but a complete infection control system requires every surface, every breath of air, and every moment between patients to be managed.

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Hospital-Grade Surface Disinfection
All clinical surfaces — chairs, lights, bracket tables, handles, and switches — are wiped with an EN 14476-validated viricidal disinfectant between every patient contact, with a mandatory contact time before the next patient enters.
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HEPA-Filtered Ventilation
Our treatment rooms are ventilated with HEPA H13 filtration, capturing 99.95% of aerosol particles ≥ 0.3 µm — including dental aerosols generated during ultrasonic scaling, drilling, and high-speed handpiece use.
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Pre-Procedural Mouth Rinse
Before every appointment involving aerosol generation, patients rinse with 0.2% chlorhexidine or 1% hydrogen peroxide — reducing oral bacterial load by up to 99% before a single instrument enters the mouth.
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Dental Unit Waterline Management
Waterlines supplying the air-water syringe, handpiece, and ultrasonic scaler are shocked weekly with chemical treatment and flushed before every patient. Independent waterline tests confirm microbial counts remain within ADA/CDC guidelines.
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UV-C Disinfection (End of Day)
At the close of each clinical session, treatment rooms undergo a UV-C disinfection cycle targeting residual airborne and surface pathogens — a supplementary layer beyond manual cleaning and surface disinfection.
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Segregated Clinical Waste Disposal
Clinical waste, sharps, and pharmaceutical waste are segregated at point of generation into colour-coded bins and collected by a licensed clinical waste contractor — compliant with Biomedical Waste (Management & Handling) Rules, India.

Your Safety Experience

What You Can See and Ask
at Every Appointment

Transparency is part of our infection control commitment. You are entitled to see our sterility evidence — and we encourage you to ask.

Before You Sit Down
The clinical team changes gloves, mask, and apron before you enter. You will observe fresh surface barriers on all touch surfaces. The chair and light will have been cleaned and disinfected since the previous patient.
Visible to you
Instrument Opening
Your instruments arrive at chairside in sealed sterilisation pouches with the chemical indicator strip visible and colour-changed (confirming processed status). They are opened in front of you — never pre-opened or left on an open tray in advance.
Opened in front of you — always
Needle and Cartridge Opening
Your anaesthetic needle and cartridge are taken from sealed packaging and assembled in your presence. The needle cap is removed and the cartridge cracked in front of you — confirming nothing has been pre-loaded from a previous patient.
You see it, you hear it
Ask Us Anything
You are welcome to ask to see the cycle print record for your instruments, the Bowie-Dick test result for the day, or the spore test certificate. We maintain these records and will share them without hesitation.
Records available on request
After Your Appointment
Every used instrument is logged, bagged, and returned to the decontamination room immediately. No used instrument sits in the open treatment room between patients. The room is fully cleaned before anyone else enters.
Zero cross-patient contact

Why Aspen Dental Care

Why Our Sterilisation
Standard Matters to You

Many clinics have a steriliser. Far fewer have a validated Class B programme, documented protocols, and the culture of transparency that makes infection control real rather than assumed.

🏥
Hospital-Equivalent Safety
The SAL 10⁻⁶ achieved by Class B sterilisation is the same standard required in surgical theatres. You receive operating-room-level sterility for every instrument that enters your mouth — not just approximate safety.
🛡️
Protection Against Blood-Borne Viruses
Hepatitis B is 100× more transmissible than HIV via contaminated instruments. Our Class B cycle eliminates all blood-borne viruses including hepatitis B, hepatitis C, and HIV with absolute certainty — every cycle, every instrument.
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Prion Elimination Protocol
Prions (responsible for Creutzfeldt-Jakob disease) are resistant to most disinfection. Our extended cycle at 134°C combined with alkaline pre-cleaning follows WHO guidance for prion risk reduction — an additional layer most dental practices do not address.
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Full Regulatory Traceability
Every instrument processed through our autoclave is linked to a specific cycle record. In the extremely unlikely event of a cycle failure, we can identify precisely which patients were affected and take immediate action — no guesswork.
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Microscope + Sterile Instruments
Our dental operating microscope allows us to verify that instruments are genuinely clean before sterilisation — spotting residual debris in fine-tipped or hollow instruments that visual inspection alone would miss.
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Radical Transparency
You are welcome to visit our decontamination room, inspect our autoclave print records, and review our validation certificates. We believe patients deserve to see the evidence of the safety they are trusting us with.

Questions Answered

Frequently Asked Questions
About Our Sterilisation

Is Class B sterilisation mandatory for dental clinics in India? +
The Dental Council of India and state health departments mandate sterilisation compliance, and the guidelines specify autoclaving as the preferred method. However, the specific autoclave class (N, S, or B) is not always formally enforced at clinic level in India. This is precisely why patient awareness matters — a clinic choosing Class B does so because it is the correct standard, not merely because it is the minimum required. At Aspen, we have chosen the EN 13060 Class B standard because we believe you deserve the highest level of protection available.
Can I ask to see the sterilisation records for my instruments? +
Absolutely — and we actively encourage it. We maintain printed cycle records for every autoclave run, the daily Bowie-Dick test results, monthly spore test certificates, and instrument traceability logs. Ask any member of our clinical team and we will show you the records immediately. A clinic that has nothing to hide has every reason to be transparent about its sterilisation practices.
How do I know the instruments used on me were sterile? +
Every instrument at Aspen Dental Care arrives at chairside sealed in a sterilisation pouch with a colour-changed chemical indicator — visible proof that the contents have been through the autoclave cycle. Instruments are opened from their pouches in front of you at every appointment. You can additionally request the cycle print record for your specific instrument batch — we will produce it without hesitation.
What is the difference between disinfection and sterilisation? +
Disinfection reduces the number of microorganisms to a safe level but does not eliminate all life forms — particularly bacterial spores. Sterilisation is the complete elimination of all microbial life including spores, to a Sterility Assurance Level (SAL) of 10⁻⁶ — meaning fewer than one instrument in a million could harbour any viable microorganism after processing. Only sterilisation — specifically Class B autoclaving — is appropriate for dental instruments that penetrate tissue or contact blood.
Are dental handpieces (drills) sterilised between patients at Aspen? +
Yes — without exception. Dental handpieces are the most critical and most neglected instrument in many clinics. Because they are hollow, Class N and some Class S autoclaves cannot adequately sterilise them. Our Class B autoclave is the only type validated for hollow instrument sterilisation, and every handpiece used at Aspen goes through the full pre-vacuum Class B cycle after every patient. Handpieces are also internally flushed before autoclaving to remove debris from the turbine channels.
What happens if an autoclave cycle fails validation? +
If a cycle print record or biological/chemical indicator shows a failure, the entire cycle is quarantined immediately. No instruments from that cycle are used. The autoclave is taken out of service, a fault investigation is conducted, and instruments are reprocessed in a validated cycle on a back-up unit. Patients whose appointments coincide with a confirmed cycle failure are contacted and assessed in line with the regulatory guidance. In practice, this is an extremely rare event — our validation programme is designed to detect potential issues before they become failures.
Do you use single-use instruments where possible? +
Yes. Wherever a single-use alternative exists and is clinically equivalent, we use it — including needles, suction tips, saliva ejectors, prophy cups, impression materials (where appropriate), and all surface barriers. Reusable instruments are reserved for items where single-use is not practically available or clinically suitable, and these are always processed through the full Class B sterilisation cycle.

Your Safety Is Our First Promise

Book a consultation and experience dentistry where every instrument meets hospital-grade sterility standards — every time, without exception.

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