17/30363625 DC

Действует

BS EN ISO 11138-7. Sterilization of health care products. Biological indicators. Part 7. Guidance for the selection, use and interpretation of results — 72 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 13485:2016

Действует

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.

BS EN 285:2015

Действует

Sterilization. Steam sterilizers. Large sterilizers — 104 стр.

ISO 9000:2015

Действует

Quality management systems -- Fundamentals and vocabulary — 58 стр.

ISO 11138-5:2017

Действует

Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes — 14 стр.

ISO/IEC 17025:2005

Заменен

General requirements for the competence of testing and calibration laboratories — 36 стр.

ISO/IEC 17011:2004

Заменен

Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies — 28 стр.

ISO 9001:2015

Действует

Quality management systems -- Requirements — 40 стр.

ISO 11138-1:2017

Действует

Sterilization of health care products -- Biological indicators -- Part 1: General requirements — 48 стр.

ISO 11138-2:2017

Действует

Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes — 14 стр.

ISO 11138-3:2017

Действует

Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes — 16 стр.

ISO 11138-4:2017

Действует

Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes — 16 стр.

ISO 11737-1:2006

Заменен

Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products — 42 стр.