BS EN ISO 11137-3:2006

Заменен

Sterilization of health care products. Radiation. Guidance on dosimetric aspects — 28 стр.

Ссылочные документы

ISO 11137-1:2006/Amd.1:2013

Действует

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1 — 10 стр.

ISO 9001:2015

Действует

Quality management systems -- Requirements — 40 стр.

ISO 13485:2016

Действует

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

ASTM E2232-02

Заменен

Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications — 16 стр.

ASTM E2303-03

Заменен

Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities — 9 стр.

BS EN ISO 11137-3:2017

Действует

Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control — 50 стр.

На этот документ ссылаются

BS EN 13544-1:2007

Действует

Respiratory therapy equipment. Nebulizing systems and their components — 44 стр.

BS EN ISO 7198:2017

Действует

Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.

BS EN ISO 11137-3:2017

Действует

Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control — 50 стр.

BS EN 552:1994

Заменен

Sterilization of medical devices. Validation and routine control of sterilization by irradiation — 36 стр.