SS-EN-ISO-11137-2-AM1 › Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

SS-EN-ISO-11137-2-AM1 - 2015 EDITION AMENDMENT 1 - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


This part of ISO 11137 specifies methods for 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

UL-94
Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances

BS-EN-ISO-13485
Medical devices. Quality management systems. Requirements for regulatory purposes

SOR/98-282
Medical Devices Regulations (Canada)

ORDER

Price:

$124.95        


Want this as a site license?



Designation Name

SS-EN ISO 11137-2:2015/A1:2023

Revision Level

2015 EDITION AMENDMENT 1

Status

Current

Publication Date

April 24, 2023

Language(s)

English

Page Count

16

International Equivalent

EN ISO 11137-2:2015/A1:2023(IDT); ISO 11137-2:2013/Amd 1:2022(IDT)