The ISO 14644 standard is designed to identify clean rooms and controlled environments with these rooms. The Turkish Standards Institute has prepared the TS 11605 standard based on this standard and making it suitable for the conditions of our country.

ISO 14644 standard It consists of nine parts:

  • Section 1: Classification of air cleanliness
  • Section 2: Test and monitoring conditions for continuous compliance with ISO 14644 standard
  • Section 3: Test methods
  • Section 4: Design, construction and commissioning
  • Section 5: Business
  • Chapter 6: Terms and definitions
  • Part 7: Separating tools (fresh air hoods, gloved boxes, insulators, mini-media, etc.)
  • Chapter 8: Classification of airborne molecular contamination
  • Section 9: Classification of surface particle cleaning

According to this standard clean roomare enclosed chambers which are controlled in terms of atmospheric conditions, ie conditions such as ventilation, temperature, relative humidity and pressure, minimizing the introduction, formation and retention of particles.

Again, according to the standard, the clean zone is a portion of the clean room, which may have the same conditions as the clean room described above, or an open or closed zone.

TS 11605 EN ISO 14644-1 standardis composed of the following four headings and six annexes for information:

1. Scope

2. recipes

3. Classification

4. Demonstration of compliance

Appendix A (For information) Table Graphical representation of classes in 1

Appendix B Discrete particle counter, determination of particle cleanliness using a light dispenser

Annex C Statistical evaluation of particle concentration data

Appendix D (For information) Examples of calculations made for classification purposes

Annex E (for information) Assessments for the counting and sizing of particles outside the size range applicable to the classification

Appendix F (For information) Sequential sampling

Clean room tests, TS 11605 standard taking into account the values ​​and controls are made according to the measurements. These tests performed by authorized testing and inspection organizations or laboratories are predominantly based on human health. As such, it is made by organizations that provide services or production that affect human health in particular. Hospitals, health institutions, pharmaceutical manufacturers, laboratories and food sector companies are the leading ones. These organizations have to test whether their clean rooms meet the standards.

These tests testing and inspection organizations and laboratories are organizations that are authorized by the relevant accreditation bodies and have to operate impartially and independently.

The TÜRCERT certification body provides conformity assessment, certification and training services, while providing testing and inspection services. Clean room testing is one such service. In order to get more information and to have these tests done and to report the results, do not hesitate to contact the experienced managers and employees of the TÜRCERT certification body.