ISO 11137-2:2006 PDF
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 60
- Дата публикации:
- 19 апреля 2006 г.
- Издание:
- ISO IS 11137 edition 1 version 1
- ICS:
- 11.080.01
ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11137-2:2006
Похожие стандарты
Другие стандарты ISO
ISO 8689-1:2000
ДействующийWater quality — Biological classification of rivers — Part 1: Guidance on the interpretation of biological qu…
Overview ISO 8689-1:2000, titled Water quality - Biological classification of rivers - Part 1: Guidance on the interpretation of biological quality data from surveys of benthic macroinvertebrates, is…
ISO/ASTM51540-04(2012)
ОтменёнStandard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)
Significance and Use4.1 The radiochromic liquid dosimetry system provides a means of measuring absorbed dose in materials (5-7). Under the influence of ionizing radiation, chemical reactions take pla…
ISO/ASTM51204-04
ДействующийStandard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)
Significance and Use4.1 Food products may be treated with ionizing radiation, such as gamma-rays from 60Co or 137Cs sources, for numerous purposes, including control of parasites and pathogenic micro…
ISO/ASTM51431-05
ОтменёнStandard Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food P…
Significance and Use4.1 Food products may be treated with acceleratorgenerated radiation (electrons and X-rays) for numerous purposes, including control of parasites and pathogenic microorganisms, in…
ISO/ASTM52628-20e1
ДействующийStandard Practice for Dosimetry in Radiation Processing
1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance o…
ISO/ASTM52921-13(2019)
ДействующийStandard Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies
Significance and Use 3.1 Although many additive manufacturing systems are based heavily upon the principles of Computer Numerical Control (CNC), the coordinate systems and nomenclature specific to CN…
ISO/ASTMTR52917-EB
ДействующийAdditive Manufacturing — Round Robin Testing — General Guidelines
This document outlines the steps with regard to aspects of design to conduct and run a round robin study (RRS) to assess the degree of variability in an additive manufacturing material or process. Th…
ISO/ASTM52901-17(2023)
ДействующийStandard Guide for Additive Manufacturing – General Principles – Requirements for Purchased AM Parts
Scope 1.1 This document defines and specifies requirements for purchased parts made by additive manufacturing. 1.2 It gives guidelines for the elements to be exchanged between the customer and the pa…