Swabs for microbiological sampling
Swabs are used for biological sampling. Specially used for processing samples which, after being coloured, will be analysed by microscopy. Also suitable for isolations in culture medium. Another important use is its capacity to spread dishes by dissemination techniques (for example for susceptibility testing by Kirby-Bauer or by E-test).
Swabs class IIa
The swabs for the collection and transport of microbiological samples are considered invasive surgical-type product and with a use, in compliance with the essential requirements of the “Directive 93/42/EEC. Medical devices”. According to the classification rules contained in this Directive, the swabs are part of Class IIa. The Agencia Española del Medicamento y Productos Santarios (AEMPS – ON 0318) is the institution who certifies these swabs.
Quality standards – Requirements fulfilled by swabs
1. UNE-EN ISO 556-1 Sanitary products sterilisation. Requirements to be designed as “STERILE”. Part 1: sterilised sanitary products requirements.
2. UNE-EN ISO 868-2 Packaging materials for medical devices sterilized in its final phase. Part 2: sterilization wrap. Requirements and test methods.
3. UNE-EN ISO 11737-1 Sterilization of medical devices. Microbiological methods. Part 1: determination of a population of microorganisms.
4. UNE-EN ISO 11737-2 Sterilization of medical devices. Microbiological methods. Part 2: sterility tests conducted to validate a sterilization process.
5. UNE-EN ISO 11135-1 Sterilization of medical devices. Ethylene oxide. Part 1: requirements for development, validation and control of the routine of a sterilization process of medical devices.
6. UNE-EN ISO 11137-1 Sterilization of health care products. Radiation. Part 1: requirements for the development, validation, and control of the routine of a sterilization process of PS.
7. UNE-EN ISO 11137-2 Sterilization of health care products. Radiation. Part 2: setting the sterilization dose.
8. UNE-EN ISO 15223-1 Sanitary products. Symbols to use on labels, labelling and information to be supplied. Part 1: general requirements.
9. UNE-EN ISO 14971 Sanitary products. Application of risk on management.
10. UNE-EN ISO 13485 Sanitary products. Systems of quality management. Requirements for regulatory purposes.