Dokumen ini memberikan gambaran kisaran biaya jasa konsultan untuk mendampingi organisasi dalam implementasi ISO hingga tahap audit eksternal/sertifikasi.
ISO DIS 11135 - Draft Ethylene Oxide sterilization standard for medical devices available for comment
For anyone that works in the medical device sector, the following standard is key to demonstrating ethylene oxide sterilization processes are validated and controlled thereby ensuring the sterility of the final product: