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The draft E DIN EN 13060:2002-05 specifies requirements for small steam sterilizers for medical applications and defines test methods, performance characteristics, and safety aspects.
Scope
The draft standard E DIN EN 13060:2002-05 describes requirements for small steam sterilizers used for medical purposes or for materials that may come into contact with blood or body fluids. They are mainly used for sterilizing medical instruments and have a usable space of less than 1 cu. ft. or a volume of less than 60 liters.
Examples of areas of application:
- Medical, dental, and veterinary practices
- Acupuncture treatments
- Cosmetic surgery
- Tattoo and piercing studios
Specified test loads
- Unpackaged solid products
- Full load with porous products
- Partial load with porous products
- Porous small parts
- Hollow articles type A and type B
- Simply packaged products
- Double-packaged products
Exceptions – Not applicable to:
- Sterilization of liquids
- Sterilization of pharmaceutical products
Contents of the standard
- General technical requirements (dimensions, materials, construction, instruments, displays, control systems, accessories)
- Performance requirements (air leakage, sterilization conditions, drying, germicidal effect, non-condensable gases)
- Safety requirements
- Types of testing: type testing, factory testing, acceptance testing
- Test equipment: temperature, pressure, air leakage, test loads, test specimens
- Test programs for sterilization cycles type B, N, S
Sterilization cycles – type overview
| Type | Description of use |
|---|---|
| B | Sterilization of all packaged or unpackaged solid, hollow, and porous products in accordance with the test loads specified in prEN 13060 |
| N | Sterilization of unpackaged solid products |
| S | Sterilization of products according to manufacturer's instructions, including unpackaged solid products and at least one of the following loads: porous products, hollow articles type A/B, single or double packaged products |
Note: Unpackaged sterilized products of type N are intended for immediate use or non-sterile storage/transport (e.g., to prevent cross-contamination).
Test procedures & test objectives
- Air leakage test: Ensuring a saturated vapor atmosphere without air ingress during vacuum phases. No recontamination during cooling and drying.
- Dynamic pressure test: Limitation of pressure fluctuations to protect the packaging material.
- Empty chamber test: Evaluation of temperature and pressure control without load.
- Test with test load: Verification of complete fulfillment of sterilization conditions in the chamber and load.
- Drying test: Ensures dry results without moisture problems (packaging, shelf life, recontamination).
- Residual air determination: Determination of non-condensable gases in the chamber.
- Microbiological test: Proof that no biological indicators are revived under correct conditions.